| |

Received: 3 April 2023    Revised: 20 May 2023    Accepted: 7 June 2023

DOI: 10.1111/clr.14116

ORIGINAL ARTICLE

Surgical peri-­implantitis treatment with and without guided

bone regeneration. A randomized controlled trial

Lisa J. A. Heitz-­Mayfield1,2,3  | Fritz Heitz3 | Bernard Koong4 | Tom Huang4 |

Paola Chivers5,6

1
International Research Collaborative,
Oral Health and Equity, School of Human Abstract
Anatomy and Biology, The University
Objective: To evaluate the efficacy of reconstructive peri-­implantitis treatment.
of Western Australia, Crawley, Western
Australia, Australia Materials and Methods: Forty participants, with peri-­implantitis and a contained in-
2
Faculty of Medicine and Health, School traosseous defect, were randomized to access flap (control) or access flap with xen-
of Dentistry, The University of Sydney,
Sydney, New South Wales, Australia
ograft and collagen membrane (test). All received systemic antimicrobials. Blinded
3
Perth Periodontal Specialists, West examiners recorded probing depths (PD), bleeding and suppuration on probing (BOP
Leederville, Western Australia, Australia & SOP), soft tissue levels, and marginal bone levels (MBL) at baseline and 12 months.
4
Envision Medical Imaging, Wembley,
Patient reported outcomes were recorded. The primary outcome was PD change.
Western Australia, Australia
5
Institute for Health Research, The Results: All 40 participants (40 implants) completed the 12-­month study. The mean
University of Notre Dame, Fremantle, (standard deviation) PD reduction (deepest site) was 4.2 (1.8) mm in the control and
Western Australia, Australia
6 3.7 (1.9) mm in the test group. MBL gain (deepest site) was 1.7 (1.6) mm in the control
School of Medical and Health Sciences,
ECU, Joondalup, Western Australia, and 2.4 (1.4) mm in the test group. Absence of BOP & SOP was observed at 60%
Australia
of both control and test implants. Buccal recession was 0.9 (1.6) mm in the control
Correspondence and 0.4 (1.1) mm in the test group. A successful outcome (absence of PD ≥ 5 mm with
Lisa J. A. Heitz-­Mayfield, International
BOP, absence of SOP and absence of progressive bone loss) was achieved for 90%
Research Collaborative, Oral Health
and Equity, School of Human Anatomy of the control and 85% of test group implants. No statistically significant differences
and Biology, The University of Western
in clinical or radiographic parameters were found between treatment groups. 30%
Australia, Crawley, WA, Australia.
Email: heitz.mayfield@iinet.net.au of participants experienced mild gastro-­intestinal disturbances. Reporting followed
CONSORT guidelines.
Funding information
Osteology Foundation, Grant/Award Conclusion: Similar clinical and radiographic improvements at 12 months were ob-
Number: 14075
served with high levels of patient satisfaction for both the access flap and xenograft
covered by collagen membrane groups.
Registered clinical trials.gov. ID:NCT03163602 (23/05/2017).

KEYWORDS
bone grafting, bone regeneration, clinical trials, patient reported outcome measures, peri-­
implantitis, randomized controlled trial, surgical procedures

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in
any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2023 The Authors. Clinical Oral Implants Research published by John Wiley & Sons Ltd.

Clin Oral Impl Res. 2023;00:1–19.  |

wileyonlinelibrary.com/journal/clr     1
 |
2      HEITZ-­MAYFIELD et al.
1  |  I NTRO D U C TI O N
Peri-­implantitis is a plaque associated pathological condition at osse-
ointegrated implants, characterized by clinical signs of inflammation
(BOP) and progressive bone loss, (Berglundh et al., 2018). In addition,
suppuration, deep probing depths (PD > 6 mm), and or peri-­implant
mucosal recession are frequently observed. The primary goals of
peri-­implantitis treatment are to resolve the peri-­implant inflamma-
tion and prevent further bone loss.
Absence of BOP and probing depths ≤5 mm have been shown
to be good predictors for long-­t erm peri-­implant tissue stability
(Karlsson et al., 2019). Therefore, it is reasonable to define a suc-
cessful outcome at the endpoint of peri-­implantitis treatment
as the establishment of shallow peri-­implant probing depths
(PD ≤5 mm), with the absence of BOP/SOP, and no additional
bone loss. Treatment studies, however, report that complete
resolution of peri-­implant inflammation (absence of BOP at all
sites) following treatment, is difficult to achieve (Heitz-­M ayfield
et al., 2018).
If non-­surgical treatment of peri-­implantitis is unsuccessful in
resolving inflammation and reducing probing depths, a surgical ap-
proach, with the aim of gaining access to the exposed implant sur-
face for decontamination, is indicated (Heitz-­Mayfield et al., 2012;
Karlsson et al.,  2019). Furthermore, if the peri-­implant defect has
an associated contained (3-­ or 4-­wall) intra-­osseous component,
a so-­called reconstructive approach (application of a bone graft/
substitute or biologically active material with or without a barrier
membrane), may be applied with the aim of regeneration of the peri-­
implant bone defect in addition to resolving inflammation (Tomasi
et al., 2019).
Systematic reviews have described the outcomes of recon-
structive approaches for treatment of peri-­implantitis reporting
clinical and radiographic improvements following these procedures
(Khoshkam et al.,  2013; Tomasi et al.,  2019). However, few ran-
domized controlled trials addressing the efficacy of reconstruc-
tive surgical therapy are available (Derks, Ortiz-­Vigon, et al., 2022;
Isehed et al., 2018; Jepsen et al., 2016; Renvert et al., 2021; Tomasi
et al., 2019) and further studies are required.
The objective of this randomized controlled trial was to evaluate
the potential clinical benefits of reconstructive surgical therapy of
peri-­implantitis, using a guided bone regeneration (GBR) approach
(xenograft covered with a collagen membrane) compared to access
flap surgery without GBR.
2  |   M ATE R I A L S A N D M E TH O DS
2.1  |  Ethics approval and trial registration
Ethics approval was obtained from the Human Ethics Committee
at The University of Western Australia (RA/4/1/7531) prior to en-
rolment of the first participant. The study protocol was registered
prospectively (23 May, 2017) at clini​caltr​ials.gov (NCT03163602).
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
The reporting of the study follows the CONSORT (2010) guidelines
(Schulz et al., 2011).
2.2  |  Hypothesis and trial design
The hypothesis of this parallel, randomized, single-­blinded controlled
trial was that surgical reconstructive treatment of peri-­implantitis
(xenograft covered by a resorbable collagen barrier membrane), (test
group), would result in greater clinical benefits with respect to; PD
reduction (primary outcome), resolution of inflammation (absence of
BOP/SOP), gain in peri-­implant bone, stability of peri-­implant mu-
cosal levels and patient reported outcomes (PROs), compared to ac-
cess flap surgery (control group).
Participants were randomly assigned to either control or test
group (ratio 1:1) using a computer-­generated randomization table
with a block size of 4. Allocation to treatment group was concealed
in opaque envelopes which were consecutively assigned to partici-
pants by a study assistant (PF), who was not involved in the treat-
ment. The envelope containing the treatment allocation was opened
only after intra-­surgical confirmation of the suitability of the peri-­
implantitis defect for inclusion in the study (i.e. a contained (3-­ or
4-­wall) intra-­osseous defect ≥3 mm in depth).
Examiners were blinded to the treatment group throughout the
study period. When one periodontist (LHM) carried out the peri-­
implantitis treatment the second periodontist (FH) made the base-
line examination and 12-­month re-­evaluation measurements, and
vice-­versa.
The patients, while not blinded to the treatment group, were in-
structed not to disclose the treatment group allocation to the exam-
iner throughout the study period.
2.3  |  Study population and recruitment
Eligible participants were adults (aged ≥ 18 years), with one or more
osseointegrated dental implants diagnosed with peri-­implantitis
requiring surgical intervention. Participants were recruited from a
referral-­based specialist periodontal practice and treatment was
completed by one of two periodontists (FH/LHM) both of whom had
more than 18-­years' experience in periodontal and implant regener-
ative procedures. Participants were provided with written informa-
tion regarding the aims of the study and provided informed consent
prior to enrollment. The study commenced in May 2017 and was
completed in September 2022. The study flow diagram according to
CONSORT guidelines is presented in Figure 1.
2.4  |  Inclusion criteria
Criteria for inclusion were (i) peri-­implantitis defined as clinical inflam-
mation (BOP and/or SOP) with probing depths (PD) ≥ 5 mm in addition
to progressive bone loss resulting in contained, semi-­circumferential
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
HEITZ-­MAYFIELD et al.       3

Enrollment Assessed for eligibility (n= 50)

Excluded (n= 10)

 Not meeting inclusion criteria (n=10)
PD < 5 mm following non-surgical
treatment (n=2).
unsuitable defect morphology (n=8)
 Declined to participate (n= 0)

Randomized (n= 40)

Allocation
Control (n= 20) Access flap Test (n= 20) GBR
 Received allocated intervention (n= 20)  Received allocated intervention (n= 20)

12 Month
N = 20 N = 20
Follow-Up

Analysis

Analysed (n= 20) Control Access flap Analysed (n=20) Test GBR

F I G U R E 1  CONSORT 2010 flow diagram.

(3-­wall) or circumferential (4-­wall) intraosseous defects with a depth 2.6  |  Calibration

of ≥3 mm, (ii) a minimum width of 2 mm of keratinized peri-­implant mu-
cosa on the buccal and lingual aspects in order to facilitate flap man-
agement, (iii) an implant-­supported prosthesis with sufficient access
for oral hygiene measures and peri-­implant probing. Where more than
one implant per participant was diagnosed with peri-­implantitis, and
required surgical intervention, the implant with the deepest probing
depth was chosen for the analysis.
An investigator meeting was held prior to the commencement of the
study to standardize the examination, defect inclusion criteria, and
treatment protocols during the routine treatment of a patient with
peri-­implantitis who was not involved in the study.
2.7  |  Interventions

2.5  |  Exclusion criteria 2.7.1  |  Pre-­surgical treatment

Exclusion criteria were (i) systemic conditions potentially affecting
healing such as uncontrolled diabetes mellitus or prescribed medica-
tions such as bisphosphonates (ii) systemic antimicrobial use within
the past 6 months, (iii) smokers reporting >10 cigarettes per day (iv)
patients reporting allergy to chlorhexidine digluconate, amoxicillin,
or metronidazole.
Participants received periodontal treatment, as required, in the
remaining dentition prior to enrolment. All patients were required
to have a full mouth plaque score (FMPS) ≤ 25% and a full mouth
bleeding score (FMBS) ≤ 25% prior to the surgical intervention. Non-­
surgical peri-­implantitis treatment, including individualized oral hy-
giene instructions (OHI) and removal of calculus and biofilm using
 |
4      HEITZ-­MAYFIELD et al.
hand instruments and air-­powder abrasion with erythritol powder
(EMS Air-­Flow Master, E.M.S. Electro Medical Systems S.A. CH-­
1260), was provided approximately 4–­6 weeks prior to baseline
measurements and surgical treatment.
2.7.2  |  Baseline measurements (prior to surgery)
The following baseline measurements were made; (i) FMPS (pres-
ence of dental plaque along the peri-­implant mucosal/gingival mar-
gin expressed as a percentage of examined sites within the mouth,
four sites per implant/tooth), (ii) FMBS (presence of BOP, within 10 s,
expressed as a percentage of examined sites within the mouth, four
sites per implant/tooth), (iii) probing depths at all teeth/implants
within the mouth (four sites per implant/tooth).
At the implant to be treated the following clinical measurements
were recorded at four sites per implant (distal, buccal, mesial, oral); (i)
presence/absence of plaque, (ii) presence/absence of BOP, (iii) pres-
ence/absence of SOP, and (iv) peri-­implant soft tissue level measured
from a fixed reference (e.g. incisal edge of the prosthesis or pros-
thesis margin). A standardized graduated manual probe (PAUNC15
G. Hartzel & Son) was used with a light probing force (approx 0.2 N).
Measurements were recorded to the nearest mm. The prosthesis mar-
gin, at the implant to be treated, was classified as sub-­or supra-­mucosal.
Intraoral digital radiographs, at the implant to be treated, were
made using a long-­cone paralleling technique with the aid of a RINN
holder (Dentsply International). Small field of view (5 × 5 cm) cone
beam CT scans were also made with OP300 Maxio (Instrumentarium)
at 90 kVp and 23.4mAs, with a voxel size of 0.085 mm.
2.7.3  |  Surgical treatment procedures
The implant-­supported prostheses were not removed prior to sur-
gery, with the exception of one participant where the prosthesis was
disconnected to provide improved access. Following local anesthe-
sia, mucoperiosteal flaps were elevated at the implant site in order
to gain access to the intra-­osseous peri-­implant defect and exposed
implant surface. Vertical releasing incisions were used if required.
Inflamed tissue was removed from the intra-­osseous defects using
titanium curettes. The exposed implant surfaces were thoroughly
cleaned using an ultrasonic device with fine titanium tips (IP2L, IP2R;
Acteon) under continuous sterile saline irrigation.
The peri-­implantitis defects were evaluated to verify that they
were suitable for inclusion (i.e. contained (3-­ or 4-­wall) defect with
depth ≥ 3 mm) prior to allocation to treatment group. Intra-­surgical
measurements at four aspects per implant (mesial, distal, buccal,
oral) were recorded including the intraosseous defect depth and
width, and the distance from the restorative margin to the base of
the defect. The intraosseous defect morphology was also described
(circumferential [i.e. 4-­wall]/semi-­circumferential [i.e. 3-­wall]).
In the control group mucoperiosteal flaps were positioned, with-
out apical displacement, to achieve primary closure and sutured using
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
non-­resorbable monofilament 5/0 sutures for transmucosal healing. In
the test group the intraosseous component of the peri-­implant defect
was filled with a xenograft (deproteinized bovine bone mineral [DBBM],
Bio-­Oss granules [0.25–­1 mm], Geistlich Pharma AG). No attempt to
overfill the intraosseous defect was made. A resorbable bi-­layer col-
lagen barrier membrane (Bio-­Gide, Geistlich Pharma AG) was adapted
to cover the graft material extending 1–­2 mm beyond the defect. Flaps
were positioned to achieve primary closure and sutured using non-­
resorbable monofilament 5/0 sutures for transmucosal healing.
All participants received 2 × 500 mg paracetamol following the
surgical procedure and were advised to take analgesics for the first
24 h and then as required.
Participants completed a VAS questionnaire relating to surgical
pain experienced (Appendix 1).
2.7.4  |  Post-­surgical protocol
Systemic antimicrobials (amoxicillin 500 mg, 3 times daily + metroni-
dazole 400 mg, 3 times daily) were prescribed for 7 days commenc-
ing on the day of surgery. In both treatment groups post-­operative
care instructions were provided in written and oral form including
(i) no routine brushing at the treated site for a period of 4 weeks, (ii)
twice daily rinsing with 10 mL of 0.2% chlorhexidine mouth-­rinse for
60 s for a period of 4 weeks, (iii) application of 0.2% chlorhexidine
digluconate solution using an extra-­soft post-­surgical toothbrush
(TePe Munhygienprodukter AB) commencing on day 3 after surgery
until 4 weeks. At 4 weeks participants were instructed to resume
routine oral hygiene procedures (brushing and interproximal clean-
ing) and chlorhexidine rinsing was discontinued.
2.7.5  |  One-­week post-­operative visit
Sutures were removed at 1 week and participants completed a VAS
questionnaire (Appendix 1). Any adverse events were recorded and
the surgical site was assessed for signs of oedema, flap dehiscence,
barrier membrane or graft exposure, or infection (suppuration).
2.7.6  |  Four-­week post-­operative visit
At 4 weeks the surgical site was assessed and supra-­gingival/mu-
cosal chlorhexidine stain or plaque was removed if present using a
rubber cup and polishing paste.
2.7.7  |  Supportive peri-­implant care (SPIC)
Participants were reviewed at 3 monthly intervals following sur-
gery and full-­mouth supportive care was provided. Supportive
peri-­implant care (SPIC) included (i) reinforcement of oral hygiene in-
structions and risk-­factor control (ii) professional mechanical plaque

HEITZ-­MAYFIELD et al.
removal (PMPR) at the treated implant site using air-­powder abra-
sion with erythritol powder and (iii) professional mechanical calcu-
lus/plaque removal at the dentition/other implants as required.
2.7.8  |  Patient reported outcome measures
Patient reported outcomes (PROs) were recorded at baseline, im-
mediately after surgery and at 1 week and 12 months after surgery.
Participants were provided with written questions and asked to mark
a single line on a VAS scale from 0 to 100 mm. The participants re-
ceived training in how to fill out a VAS prior to completing the ques-
tionnaires. Questionnaires were completed without interference
from the treatment team. The questions addressed the following; (i)
satisfaction with appearance of the implant restoration (baseline and
12 months), (ii) pain experienced during the surgical procedure (iii) pain
experienced during the first week after surgery, (iv) disruption to nor-
mal daily activities during the first week after surgery, (v) whether the
participant would choose to have an implant if they had known they
would need to undergo the peri-­implantitis surgery (Appendix 1).
2.7.9  |  Re-­evaluation
Clinical measures (PD, presence or absence of plaque, BOP and
suppuration, peri-­implant soft tissue level) made at baseline (prior
to surgery) were repeated at 3, 6, 9, and 12 months at the treated
implant site. FMPS was recorded at 3, 6, 9 and 12 months and FMBS
at 12 months.
At 12 months intraoral digital radiographs and small field of view
cone bean CT scans of the treated implant were made in the same
manner as at baseline.
2.8  |  Statistical methods and data analyses
An a priori power calculation for an independent t-­test, assuming
a 0.5 mm difference in PD change (SD: 0.5) between test and con-
trol treatment and based on a power of 80% with α of 0.05 esti-
mated a sample size of 17 patients in each group would be required.
Accounting for potential loss to follow-­up of 10%, a total sample of
40 patients were recruited for the study. Based on data from Roos-­
Jansaker et al. (2007) which identified a mean PD change of 2.9 mm
(SD: 2.0) after surgical treatment of peri-­implantitis with a bone sub-
stitute and membrane, a paired t-­test power calculation indicated a
total sample of 6 would be sufficient to detect a PD difference from
baseline for either treatment group.
All characteristics were described as frequency (f) and percent (%),
or mean (M) and standard deviation (SD) for the total sample, control
and test groups. Patient, implant site, and implant characteristics were
described at baseline. Post-­surgical follow-­up measures and patient-­
reported outcomes (VAS scores) were described if present at each time
point (f, %). Due to COVID-­19, the 1-­week and 4-­week follow-­up times
|
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
      5
varied, hence reporting includes the VAS days to first follow-­up, and
weeks to second follow-­up (M, SD, and range [min to max]). Control
versus test group differences were examined if appropriate by Fisher's
exact Chi Square (χ2), with time to follow-­up and VAS scores compared
using Mann–­Whitney U test (as data violated assumption of normality
Shapiro–­Wilk test; standardized test statistic reported). All other re-
peated outcome measures were described at 3, 6, 9 and 12 months.
Baseline to 12-­month post-­treatment change scores were calcu-
lated for FMPS, FMBS, and full mouth percent sites with PD ≥ 5 mm.
At the treated implant, pre-­post treatment change scores were cal-
culated for PD (4 sites), BOP (count at 4 sites), SOP (count at 4 sites),
peri-­implant soft tissue level (4 sites), deepest PD, MBL (distal and
mesial), deepest MBL and VAS appearance. The baseline score was
subtracted from the score at 12 months. Shapiro–­Wilk test exam-
ined change scores for normality. Only the change scores for FMPS,
FMBS and percent sites with probing depth ≥5 mm did not violate the
normality assumption and between group (control/test) differences
were examined using an independent t-­test, with differences calcu-
lated between groups (control minus test) and summarized (M, SD,
95% CI (confidence intervals)). All other characteristics were exam-
ined using the Mann–­Whitney U test. VAS appearance success (de-
fined as no change from baseline or improved score) was described (f,
%). Chi-­square analysis examined whether success differed based on
whether implants were in the aesthetic zone (defined as region 13–­
23); and whether deepest PD at 12 months (categorized as <5 mm,
5-­6 mm and >6 mm) differed between control and test groups.
A generalized linear model (normal probability distribution with
identity link function) was used to evaluate the effect of defect
geometry on treatment outcomes (change in: deepest PD, BOP,
deepest MBL, soft tissue level) with test of model effects for de-
fect description (Wald χ2, p-­value) and significant parameter effects
(beta (β) and 95% CI) reported.
2.8.1  |  Composite outcome scores
Four composite scores (success/unsuccessful) from five studies (Derks,
Ortiz-­Vigon, et al., 2022; Heitz-­Mayfield et al., 2018; Jepsen et al., 2016;
Regidor et al., 2023; Renvert et al., 2018) based on key outcomes (PD,
BOP, SOP, recession and MBL changes) were used to summarize out-
comes. In addition, a novel composite score was constructed which also
included a patient reported outcome measure. Each were described (f,
%) for the total, test and control groups with between group differences
examined using Fisher's exact Chi Square (χ2).
2.8.2  |  Radiographic marginal bone level
assessments
Two experienced oral and maxillofacial radiologists (BK & TH) per-
formed the radiologic analysis together and reached consensus
agreement for the points of measurement. Radiologists were blinded
to the treatment group and to the time point.
 |
6      HEITZ-­MAYFIELD et al.
For intraoral digital radiograph assessment at baseline and
12 months, the radiologists used consensus agreement to evaluate
the mesial and distal marginal bone levels in relation to a fixed ref-
erence point on the implant (Figures 2 & 3). Radiographic images
were calibrated using the known dimensions of the implant, or if
unknown, the digital x-­r ay sensor dimensions. Measurements were
made in mm, using RadiAnt DICOM viewer (Medicant). For CBCT
assessment, Aquarius Net (TeraRecon) viewing software was
used to evaluate the data in all relevant planes. Due to the sub-
stantial artefact present the buccal and lingual bone levels could
not be identified on the majority of the small field of view cone
beam CT scans. Therefore, these findings are not reported in this
publication.
In order to determine the reliability of the consensus agreement
protocol to obtain intraoral radiographic measurements and mea-
surement error, the radiologists examined 20 radiographs (from 10
participants, baseline and 12 months, at 2 sites, mesial and distal) on
two occasions, 2 weeks apart. Intraclass correlation coefficient (ICC)
was used to determine test–­retest and intra-­rater reliability. A two-­
way mixed-­effect model with absolute agreement was specified.
ICC values were interpreted as poor <0.5, moderate 0.5 to <0.75,
good 0.75 to <0.9 and excellent ≥0.9 (Koo & Li, 2016). Radiograph
measurements in this study reported excellent reliability (ICC = 1.00,
95% CI: 0.999 to 1.000). Between occasion absolute differences
ranged from 0 to 0.20 mm, M = 0.06 SD = 0.05 95% CI: 0.04–­0.07.
IBM SPSS v28 (IBM Corp, 2021) was used for analysis, with stan-
dardized test statistics, exact 2-­sided p-­value reported and p < .05
considered statistically significant.
3  |  R E S U LT S
All participants completed the 12-­month study period. There was
equal representation of test and control; and male and female
F I G U R E 2  Control group (a) baseline radiograph. Control group (b) 12 months radiograph.
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
participants (20:20). Participant characteristics at baseline are sum-
marized in Table 1. Participants had a mean age of 56.6 (11.7) years
at the time of surgery. While 65% of participants had a history of
periodontitis, only 7.5% reported that periodontitis was the reason
for tooth loss at the treated implant site. Participants had low FMPS
11.9% (6.4) and FMBS 8.4% (4.3). Only 10% of participants were
smokers.
Characteristics of the treated implants at baseline are summa-
rized in Table 2 including the location of the implant within the oral
cavity, the implant brand if known, implant surface (modified or non-­
modified), prosthesis-­connection type (screw-­retained or cement
retained), prosthesis margin location (supra-­ or sub-­mucosal) and
clinical measures (plaque, PD, deepest PD, BOP, SOP). The intra-­
surgical osseous defect measurements at the deepest site and de-
fect morphology are also described in Table 2.
3.1  |  One and four weeks post-­operative follow-­up
Participants had scheduled follow-­up evaluations 1 week and
4 weeks post-­surgery, although actual timing of follow-­up was varied
(Table S1). At the first follow-­up, 1-­week post-­surgery, almost one-­
third of patients experienced a systemic antimicrobial adverse event
(mild gastro-­intestinal disturbance), and these were proportionally
higher in the test group (χ2 = 6.1 p = .031; Table S1).
At the surgical site oedema was the most frequently observed
adverse event at the one-­week follow-­up (n = 5). No between group
difference was detected for oedema, at both the one-­week and the
4-­week post-­surgical follow-­ups. In the test group two participants
presented at the one-­week postoperative visit with slight (<1 mm)
exposure of the collagen membrane without exposure of the graft
material.
While the patient-­reported VAS score relating to disruption of
normal daily activities during the first week after surgery was low in

HEITZ-­MAYFIELD et al.
F I G U R E 3  Test group (a) baseline radiograph. Test group (b) 12 months radiograph.
both groups, the test group reported significantly higher VAS pain
score (U = 6.1 p = .001) and VAS disturbance of daily activity (U = 2.3
p = .024) score at the one-­week follow-­up (Table S1).
3.2  |  12-­month treatment outcomes
Treatment outcomes, 12 months after surgery, are presented in
Table  3 with the changes from baseline summarized in Table  4. At
12 months, the mean (SD) probing depth reduction at the deepest
site was 4.2 (1.8) mm in the control and 3.7 (1.9) mm in the test group.
The mean difference between control and test groups for the
change in probing depth at the deepest site, 12 months post-­surgery
was 0.45 mm, standard error (SE) 0.84, 95% confidence interval (CI)
−1.24 to 2.14 (parametric independent t-­test).
Mean MBL gain at the deepest site was 1.7 (1.6) mm in the con-
trol and 2.4 (1.4) mm in the test group (Table 4). Absence of BOP at
all sites was observed in 60% of control and 70% of test implants
(Table 3). Absence of inflammation (absence of BOP/SOP at all sites)
was observed in 60% of both control and test implants. The buccal
peri-­implant mucosal recession was 0.9 (1.6) mm in the control and
0.4 (1.1) mm in the test group (Table 4).
No statistically significant differences in clinical or radiographic
parameters were found between treatment groups.
3.3  |  Changes from baseline to 12 months
post-­surgery
The mean probing depth at each site (distal, buccal, mesial and oral)
from baseline to 12 months post-­surgery are depicted in Figure  4,
with the mean soft tissue level shown at Figure  5. Figure  6 sum-
marizes progression from baseline to 12 months post-­surgery for
the deepest probing depth (Figure  6a), mean percentage of plaque
|
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
      7
present (Figure  6b), mean bleeding on probing present (Figure  6c)
and mean of suppuration present (Figure 6d) at the treated implant. A
comparison of probing depths <5 mm, 5–­6 mm and >6 mm is depicted
at Figure 7 with no statistically significant differences between con-
trol and test groups detected at 12 months (χ2 = 1.3 p = 1.000).
3.4  |  12-­month patient reported outcomes (PROs)
Patient reported outcomes were favorable in both treatment groups
(Tables 3 and 4, Figure 8). More than three quarters of all patients
(n = 33, 82.5%) reported the same (n = 4) or an improvement (n = 29)
in VAS appearance scores at 12 months (success), with seven report-
ing a negative change (control = 5, test = 2, ranging from −1 to −31
change in VAS points). No significant association was detected for
VAS appearance success for implants within the aesthetic zone (de-
fined as region 13–­23; χ2 = 0.4, p = .751), nor between groups (con-
trol/test; χ2 = 1.6, p = .407). The majority of patients reported high
VAS scores for the question “If you had known you would need to
have the peri-­implantitis treatment would you have still chosen to
have an implant.” (Table 3, Figure 8).
3.5  |  Composite outcome scores
Composite outcome scores, including clinical and radiographic meas-
ures, as defined in five previous studies are summarized in Table 5.
In addition, a novel composite score was constructed combining
clinical, radiographic and the patient reported outcome “satisfaction
with the appearance of the implant restoration.” The degree of suc-
cess varied, from 30% to 90%, depending on the criteria used for the
composite score (Table 5). However, irrespective of the score defini-
tion, no statistically significant differences were observed between
test and control groups.
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
8      HEITZ-­MAYFIELD et al.

TA B L E 1  Patient characteristics at baseline for total, control and test groups.

Total Control (n = 20) Test (n = 20)

Characteristic Categories f/n %/ M (SD) Min–­max f/n %/M (SD) Min–­max f/n %/M (SD) Min–­max

Gender Male 20 50.0 12 60.0 8 40.0

Female 20 50.0 8 40.0 12 60.0
Age at surgery (years) 40 56.6 (11.7) 33.2–­78.8 20 54.5 (13.5) 33.2–­78.1 20 58.7 (9.6) 41.8–­78.8
Smoking history Non-­smoker 23 57.5 11 55.0 12 60.0
Former smokera 13 32.5 7 35.0 6 30.0
Smokerb 4 10.0 2 10.0 2 10.0
Medical history Nothing of note 30 75.0 15 75.0 15 75.0
Diabetes 2 5.0 1 5.0 1 5.0
Hypertension 2 5.0 0 0 2 10.0
Other 6 15.0 4 20.0 2 10.0
Medications None 22 55.0 10 50.0 12 60.0
≤5 medications 15 37.5 7 35.0 8 40.0
>5 medications 3 7.5 3 15.0 0 0
History of periodontitis No 14 35.0 7 35.0 7 35.0
Yes 26 65.0 13 65.0 13 65.0
Tooth loss due to No 37 92.5 19 95.0 18 90.0
periodontitis Yes 3 7.5 1 5.0 2 10.0
Full mouth plaque score 40 11.9 (6.4) 2–­25 20 11.3 (6.3) 2–­22 20 12.5 (6.6) 2–­25
(%)
Full mouth bleeding 40 8.4 (4.3) 2–­16 20 8.7 (4.2) 2–­16 20 8.2 (4.4) 2–­15
score (% sites)
Probing depth ≥5 mm 40 2.7 (2.4) 0–­10 20 2.4 (2.2) 0–­8 20 3.0 (2.7) 0–­10
(% sites)
Number of implants per patientc 40 2.0 (1.6) 1–­7 20 1.9 (1.4) 1–­7 20 2.2 (1.8) 1–­7
Number of implants 1 38 95.0 20 100.0 18 90.0
with peri-­implantitis 2 2 5.0 0 0 2 10.0
per patient
N years treated implant in function 40 9.6 (4.6) 1–­20 20 10.3 (3.9) 2–­20 20 8.8 (5.1) 1–­20
VAS score (0–­100) appearance of the 40 76.8 (27.7) 0–­100 20 80.9 (26.6) 0–­100 20 72.7 19–­100
implant restoration (28.8)

Abbreviations: f, frequency; %, percent; M, mean; SD, standard deviation.

a
Former smokers ranged from 2 to 45 years (M = 13.6, SD = 11.8 years).
b
Smokers smoke 3–­10 cigarettes per day (M = 7.0, SD = 3.6) and had been smoking for 30–­4 0 years (M = 35, SD = 7.1 years).
c
Implants: one n = 23 (57.5%), two n = 7 (17.5%), three n = 6 (15.0%), five n = 1 (2.5%), six n = 1 (2.5%), seven n = 2 (5.0%).

3.6  |  Effect of defect geometry 4  |  D I S C U S S I O N

The generalized linear models did not detect any significant ef-
fects of defect geometry (circumferential/semi-­circumferential)
on PD reduction at the deepest site (Wald χ2 < 0.1, p = .834), or
MBL change at the deepest site (Wald χ2 =–­1.0, p = .317), or soft
tissue level (distal Wald χ2 = 2.2, p = .137; buccal Wald χ2 = −2.3,
p = .130; mesial Wald χ2 = 0.9, p = .324). However, a significant
effect was detected in the soft tissue level lingual model (Wald
χ2 = −6.2, p = .013). Here a circumferential defect was associ-
ated with a 0.64 mm higher change in lingual recession (β = 0.64,
SE = 0.26, 95% CI: 0.14–­1.15).
This RCT showed that following surgical peri-­implantitis treatment,
with or without GBR, clinically significant improvements could be
achieved for both treatment groups at 12 months. Shallow peri-­
implant probing depths, reduction or resolution of inflammation,
and stable marginal bone levels or bone gain, with minimal soft tis-
sue recession were achieved for the majority of patients resulting in
conditions which could be maintained with regular supportive peri-­
implant care (SPIC).
The most frequently reported outcomes in studies addressing
the treatment of peri-­implantitis are probing pocket depth (PD) and
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
HEITZ-­MAYFIELD et al.       9

TA B L E 2  Implant site and implant characteristics at the treated implant at baseline for total, control and test groups.

Total Control (n = 20) Test (n = 20)

Min–­ Min–­ Min–­

Characteristic Categories f/n %/M (SD) max f/n %/M (SD) max f/n %/M (SD) max

Implant location Mandible 14 35.0 5 25.0 9 45.0

Maxilla 26 65.0 15 75.0 11 55.0
Aesthetic zone (region 18 45.0 10 50.0 8 40.0
13–­23)
Non-­esthetic zone 22 55.0 10 50.0 12 60.0
Plaque at implant site Distal present 2 5.0 2 10.0 0 0
Buccal present 2 5.0 0 0 2 10.0
Mesial present 0 0 0 0 0 0
Lingual present 2 5.0 2 10.0 0 0
Bleeding on probing Distal present 34 85.0 16 80.0 18 90.0
Buccal present 30 75.0 16 80.0 14 70.0
Mesial present 31 77.5 17 85.0 14 70.0
Lingual present 34 85.0 17 85.0 17 85.0
Suppuration on Distal present 22 55.0 10 50.0 12 60.0
probing Buccal present 30 75.0 14 70.0 16 80.0
Mesial present 18 45.0 10 50.0 8 40.0
Lingual present 12 30.0 5 25.0 7 35.0
Suppuration at implant (%) 40 51.3 0–­100 20 48.8 0–­100 20 53.8 0–­100
(30.5) (32.9) (28.4)
Probing depth Distal (mm) 40 6.1 (2.0) 2–­13 20 6.3 (2.3) 2–­13 20 5.9 (1.8) 2–­9
Buccal (mm) 40 5.0 (1.9) 1–­8 20 5.2 (1.7) 2–­8 20 4.8 (2.0) 1–­8
Mesial (mm) 40 5.7 (1.9) 2–­10 20 6.4 (1.6) 3–­10 20 5.1 (1.9) 2–­9
Lingual (mm) 40 5.2 (2.1) 1–­13 20 5.7 (2.1) 3–­13 20 4.7 (2.0) 1–­8
Probing depth deepest (mm) 40 7.2 (1.5) 5–­13 20 7.6 (1.6) 6–­13 20 6.8 (1.3) 5–­9
Implant design Bone level 32 80.0 18 90.0 14 70.0
Tissue level 8 20.0 2 10.0 6 30.0
Implant brand Nobel Biocare 24 60.0 14 70.0 10 50.0
Straumann 10 25.0 3 15.0 7 35.0
Other a 6 15.0 3 15.0 3 15.0
Implant surface Modified 39 97.5 19 95.0 20 100
Non-­modified 1 2.5 1 5.0 0 0
Prosthesis type Screw-­retained 27 67.5 11 55.0 16 80.0
Cement-­retained 13 32.5 9 45.0 4 20.0
Prosthesis margin Supramucosal 5 12.5 2 10.0 3 15.0
Submucosal 35 87.5 18 90.0 17 85.0
Intrasurgical defect RM to base (mm) 40 6.8 (2.0) 3–­12 20 6.8 (2.2) 4–­12 20 6.9 (1.9) 4–­10
deepest Depth (mm) 40 5.2 (1.7) 3–­12 20 5.3 (1.9) 3–­12 20 5.1 (1.4) 3–­8
Width (mm) 40 2.8 (0.8) 2–­5 20 2.8 (0.8) 2–­4 20 2.7 (0.8) 2–­5
Defect configuration Circumferential 18 45.0 10 50.0 8 40.0
Semi-­circumferential 22 55.0 10 50.0 12 60.0

Abbreviations: f, frequency; %, percent; M, mean; SD, standard deviation; RM, restoration margin.
a
One each of Ankylos, Astra, Implant direct, Southern Dental, unknown, Zimmer/Screw vent.

bleeding on probing (BOP) changes (Derks, Ichioka, et al.,  2022). measures of inflammation (presence or absence of BOP/SOP), prob-
A recent consensus meeting on bone regeneration recommended ing depth and bone level changes and changes in peri-­implant muco-
the use of a composite outcome variable which describes clinical sal levels (Jepsen et al., 2019).
 TA B L E 3  Treatment outcomes 12 months post-­surgery (N = 40).
|

Total (n = 40) Control group (n = 20) Test group (n = 20) Group difference
10     

M (SD) Md [IQR] Min–­max M (SD) Md [IQR] Min–­max M (SD) Md [IQR] Min–­max Test statistic a p-­value

Full mouth plaque 12.4 (5.8) 12.0 [7–­16] 3–­23 14.1 (5.9) 14.5 [8.5–­19.0] 5–­23 10.8 (5.4) 10.0 [7.0–­14.0] 3–­23 −1.7 .086
score (%)
Full mouth bleeding 3.9 (3.3) 3.0 [1–­6] 0–­12 4.5 (3.7) 3.0 [2.0–­7.3] 0–­12 3.4 (2.9) 3.0 [1.0–­6.0] 0–­10 −0.7 .461
score (%)
Full mouth PD ≥5 mm 0.2 (0.7) 0.0 [0–­0] 0–­4 0.2 (0.5) 0.0 [0–­0] 0–­2 0.3 (0.9) 0.0 [0–­0] 0–­4 0.5 .799
score (%)
Treated implant
Probing depth
Distal (mm) 3.0 (1.3) 3.0 [2.0–­4.0] 1–­4 3.1 (1.0) 3.0 [2.0–­4.0] 1–­5 2.9 (1.6) 2.0 [2.0–­4.0] 1–­7 −1.1 .301
Buccal (mm) 2.2 (0.8) 2.0 [2.0–­3.0] 1–­4 2.4 (0.8) 2.0 [2.0–­3.0] 1–­4 2.1 (0.8) 2.0 [1.3–­3.0] 1–­3 −1.2 .265
Mesial (mm) 2.7 (0.9) 3.0 [2.0–­3.0] 1–­5 2.9 (1.0) 3.0 [2.0–­3.0] 1–­5 2.5 (0.8) 3.0 [2.0–­3.0] 1–­4 −1.2 .265
Lingual (mm) 2.0 (0.7) 2.0 [2.0–­2.0] 1–­4 2.1 (0.7) 2.0 [2.0–­3.0] 1–­3 2.0 (0.8) 2.0 [1.3–­2.0] 1–­4 −0.8 .461
Probing depth 3.3 (1.2) 3.0 [2.3–­4.0] 1–­7 3.4 (0.9) 3.0 [3.0–­4.0] 2–­5 3.1 (1.5) 3.0 [2.0–­4.0] 1–­7 −1.3 .221
deepest (mm)
Visual analogue 93.5 (13.1) 98.0 31–­100 95.0 (8.2) 98.0 [94.5–­100.0] 67–­100 92.0 (16.8) 99.0 [91.3–­100.0] 31–­100 0.4 .678
scale (VAS) [92.5–­100.0]
appearance
Visual analogue 82.3 (26.9) 96.5 0–­100 b 85.8 (22.5) 96.5 [77.3–­100.0] 21–­100 78.9 (30.8) 95.0 [57.3–­100.0] 0–­100 −0.1 .904
scale (VAS) [74.5–­100.0]
choose implant

Treated implant

Total (n = 40) Control group (n = 20) Test group (n = 20) Group difference

Characteristic Categories N f (%) N f (%) N f (%) Chi-­square testc p-­value

BOP present 0 sites 26 (65.0) 12 (60.0) 14 (70.0) 3.25 .401

1 site 8 (20.0) 3 (15.0) 5 (25.0)
2 sites 5 (12.5) 4 (20.0) 1 (5.0)
3 sites 1 (2.5) 1 (5.0) 0 (0)
4 sites 0 (0) 0 (0) 0 (0)
Suppuration present 0 sites 37 (92.5%) 19 (95.0) 18 (90.0) 1.2 1.000
1 site 1 (2.5%) 0 (0) 1 (5.0)
2 sites 2 (5.0) 1(5.0) 1 (5.0)
3 sites 0 (0) 0 (0) 0 (0)
4 sites 0 (0) 0 (0) 0 (0)
a
Mann–­Whitney U test reported.
b
One patient responded 0, but responded 100 for VAS appearance.
c
Indicates Fisher–­Freeman–­Halton Exact Chi-­square test.
HEITZ-­MAYFIELD et al.

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
 HEITZ-­MAYFIELD et al.

TA B L E 4  Outcomes at 12 months post-­surgery as a change from baseline (n = 40).

Total (n = 40) Control group (n = 20) Test group (n = 20) Group difference

Test
Characteristic Categories M (SD) Md [IQR] Min–­max M (SD) Md [IQR] Min–­max M (SD) Md [IQR] Min–­max statistic a p-­value

a
FMPS (change in %) 0.6 (7.9) 0.5 [−7.0 to 6.0] −15 to 16 2.8 (7.3) 2.0 [−1.8 to 7.0] −11 to 16 −1.7 (8.0) −0.5 [−8.5 to 3.8] −14 to 15 1.9 .070

FMBS (change in % sites) −8.0 (7.7) −8.0 [−14.0 to −2.3] −25 to 8 −6.8 (7.7) −7.5 [−14.0 to −0.3] −19 to 6 −9.2 (7.6) −8.0 [−15.0 to −4.3] −8 to 25 1.0 a .338

Total BOP change (count at −2.7 (1.1) −3.0 [−4.0 to −2.0] −4.0 to −1.0 −2.6 (1.1) −3.0 [−3.8 to −2.0] −4.0 to −1.0 −2.8 (1.1) −3.0 [−4.0 to −2.0] −4.0 to −0.6 .583
four sites) −1.0

Total SOP change (count at −1.9 (1.2) −2.0 [−3.0 to −1.0] −4 to 0 −1.9 (1.3) −2.0 [−3.0 to −1.0] −4 to 0 −2.0 (1.1) −2.0 [−3.0 to −1.0] −4 to 0 −0.5 .640
four sites)

Total SOP (change in %) −48.1 (30.2) −50.0 [−75.0 to −25.0] −100 to 0 −46.3 (32.7) −50.0 [−75.0 to −25.0] −100 to 0 −50.0 (28.1) −50.0 [−75.0 to −25.0] 0 to 100 −0.5 .640

Soft tissue Distal (mm) 0.9 (1.6) 1.0 [0 to 2.0] −3 to 5 1.1 (1.9) 1.0 [0.0 to 2.0] −3 to 5 0.8 (1.2) 1.0 [0 to 1.8] −3 to 2 −0.6 .547
level
Buccal (mm) 0.6 (1.4) 0.0 [0 to 1.0] −1 to 5 0.9 (1.6) 1.0 [0 to 1.0] −1 to 5 0.4 (1.1) 0.0 [0 to 1.0] −3 to 1 −1.2 .253
change
recession Mesial (mm) 1.1 (1.5) 1.0 [0 to 2.0] −2 to 5 1.5 (1.5) 1.0 [0 to 2.0] −1 to 5 0.7 (1.3) 1.0 [0 to 1.0] −4 to 2 −1.6 .134

Lingual (mm) 0.7 (0.9) 1.0 [0 to 1.0] −1 to 3 0.8 (0.8) 1.0 [0 to 1.0] 0 to 3 0.7 (1.0) 0.5 [0 to 1.8] −2 to 1 −0.3 .779

Probing depth Distal (mm) −3.1 (2.2) −3.0 [−4.0 to −1.3] −11 to 0 −3.2 (2.4) −3.0 [−4.0 to −2.0] −11 to 0 −3.0 (2.0) −2.5 [−4.8 to −1.0] 0 to 7 0.3 .758
change
Buccal (mm) −2.8 (1.9) −2.5 [−4.0 to −1.0] −7 to 0 −2.8 (1.9) −2.5 [−4.0 to −1.3] −7 to 0 −2.7 (2.0) −2.5 [−4.0 to −1.0] 0 to 7 0.2 .841

Mesial (mm) −3.0 (2.0) −3.0 [−4.0 to −1.25] −7 to 0 −3.5 (1.8) −3.5 [−4.0 to −2.0] −7 to 0 −2.6 (2.2) −2.0 [−3.8 to −1.0] 0 to 7 1.7 .102

Lingual (mm) −3.1 (2.1) −3.0 [−4.0 to −2.0] −11 to 0 −3.6 (2.1) −3.0 [−4.8 to −2.0] −11 to −1 −2.7 (2.0) −2.0 [−4.0 to −1.0] 0 to 7 1.5 .157

Change in probing depth −3.9 (1.9) −4.0 [−5.0 to −3.0] −10 to 0 −4.2 (1.8) −4.0 [−4.8 to −3.0] −10 to −2 −3.7 (1.9) −3.0 [−5.0 to −2.3] 0 to 7 1.0 a .355
deepest (mm)

Change in Distal (mm) 1.8 (1.5) 1.7 [0.8 to 2.6] −1.1 to 6.7 1.6 (1.8) 1.5 [0.4 to 2.2] −1.1 to 6.7 2.0 (1.2) 1.7 [1.1 to 2.8] 0.3 to 4.8 1.0 .341
marginal
Mesial (mm) 1.8 (1.7) 1.5 [0.5 to 3.1] −0.5 to 7.1 1.4 (1.7) 0.8 [0.4 to 1.9] −0.5 to 7.1 2.1 (1.6) 2.3 [0.7 to 3.4] −0.4 to 1.7 .091
bone
4.8
level

Change in marginal bone level 2.0 (1.5) 1.8 [0.9 to 3.1] −0.6 to 6.7 1.7 (1.6) 1.7 [0.7 to 2.2] −0.6 to 6.7 2.4 (1.4) 2.4 [1.1 to 3.4] 0.3 to 4.8 1.7 .091
deepest (mm)

Change in visual analogue scale 16.7 (26.3) 5.0 [0–­32.3] −31 to 100 14.2 (25.0) 5.0 [−0.8 to 23.8] −6.0 to 100 19.3 (27.8) 8.0 [2.0 to 44.5] −31.0 to 0.9 .383
(VAS) appearance 75.0

Note: Change was calculated as score at 12 months subtract score at baseline. Negative values indicate a reduction in score from baseline, while positive values indicate an increase in score from baseline.
a
Indicates the parametric independent t-­test, otherwise non parametric Mann–­Whitney U test reported.
|       11

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
 |
12      HEITZ-­MAYFIELD et al.
F I G U R E 4  Mean probing depth at four sites at the treated implant from baseline to 12 months post-­surgery.
Various criteria have been used for reporting composite out-
comes of surgical peri-­implantitis treatment (Derks, Ortiz-­Vigon,
et al., 2022; Heitz-­Mayfield et al., 2018; Jepsen et al., 2016; Regidor
et al., 2023; Renvert et al., 2018). When the results from the present
study were expressed using composite success outcomes as doc-
umented in five previous studies (Derks, Ortiz-­Vigon, et al.,  2022;
Heitz-­Mayfield et al., 2018; Jepsen et al., 2016; Regidor et al., 2023;
Renvert et al., 2018), the success outcomes from the present study
were at least as favorable as the results from those studies.
It should be emphasized that the participants enrolled in this
study had high levels of self-­performed plaque control, low full
mouth bleeding scores, and low full mouth percent of sites with PDs
≥5 mm throughout the study period. In addition, all participants re-
ceived 3 monthly supportive care which commenced 3 months after
the surgical intervention.
The importance of including patient reported outcome mea-
sures in studies evaluating implant treatment has been highlighted
(Abrahamsson et al.,  2017). Hence, in the present study a novel
composite success outcome was constructed which included a
patient reported outcome, as follows (i) shallow probing depths
(PD ≤ 4 mm) at all sites, (ii) absence of SOP at all sites, (iii) absence
of BOP at all sites (iv) increase in marginal bone level of ≥1 mm
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
at the deepest site and (v) buccal mucosal recession ≤1 mm OR
patient-­reported satisfaction with the aesthetic appearance at
12 months assessed by a VAS score ≥ baseline VAS score. When
this composite success outcome was considered 42.5% of the pa-
tients had a successful outcome with no statistically significant
difference between access flap (control), and reconstructive treat-
ment (test).
The peri-­implant defect configuration has been suggested to
be an important factor in the outcome of reconstructive/regener-
ative treatment for management of periodontal and peri-­implant
intraosseous defects (Schwarz et al.,  2010). An analysis evaluating
the defect geometry and its effect on the treatment outcome failed
to identify this as a contributing factor to a successful outcome.
However, it should be emphasized that the present study included
only contained semi-­circumferential (3-­wall) or circumferential (4-­
wall) peri-­implantitis defects with an intraosseous depth of at least
3 mm. Furthermore, the implant sites had a minimum of 2 mm of ke-
ratinized mucosa on the lingual and buccal aspects facilitating sur-
gical handling.
While the need for a barrier membrane in reconstructive peri-­
implantitis treatment was not investigated in the present study the
rationale for covering the xenograft with a collagen membrane was

HEITZ-­MAYFIELD et al.
F I G U R E 5  Mean soft tissue level at four sites from baseline to 12 months post-­surgery. (increase in soft tissue level indicates soft tissue
recession).
based on the well-­established principle of guided bone regener-
ation (Dahlin et al.,  1988). Other studies have not demonstrated a
significant benefit of the adjunctive use of a resorbable membrane
to cover bone substitute materials for the reconstructive treatment
of peri-­implantitis (Regidor et al., 2023; Roos-­Jansaker et al., 2007,
2014).
A recent multicenter RCT evaluating the efficacy of a similar
bone graft material (collagenated deproteinized bovine bone min-
eral) for the reconstructive treatment of peri-­implantitis reported
no statistically significant difference in the probing depth reduc-
tion or bone level changes between access flap and the recon-
structive approach (Derks, Ortiz–­V igon et al., 2022). In that study
the baseline probing depths were deeper than those of the present
study, while the bone level gains at 12 months following treatment
were less than that of the present study. Patient-­reported out-
comes reported in the study by Derks, Ortiz–­V igon et al.  (2022)
were favourable and similar to those of the present study for both
treatment modalities.
Changes in peri-­implant mucosal levels are infrequently re-
ported in peri-­implantitis treatment studies and most studies re-
port only the buccal peri-­implant mucosal level changes. In the
present study peri-­implant mucosal level change (recession) was
evaluated at four sites per implant as interproximal recession may
|
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
      13
influence patient satisfaction with the appearance of the resto-
ration post-­t reatment. When the restoration margin was located
submucosally the incisal edge of the prosthesis was used as refer-
ence for the peri-­implant mucosal level measurement. As the path
from incisal edge to the peri-­implant mucosal margin is almost al-
ways convex there is likely measurement error inherent in using
a straight periodontal probe to measure the mucosal level. Thus,
the reported recession measurements should be interpreted with
this in mind.
Adverse events (mild, transient, gastrointestinal disturbances)
were experienced in the first week after surgery by approximately
30% of the participants. This was likely due to the systemic an-
timicrobials prescribed. There is evidence from one RCT that
systemic antibiotics have a beneficial effect on the treatment out-
come at 12 months for implants with a modified surface (Carcuac
et al.,  2016). The majority of patients in the present study had
implants with a modified surface justifying the use of systemic
antimicrobials. However, the decision to prescribe systemic anti-
microbials should be made on an individual basis considering the
possibility of adverse effects and the limited evidence supporting
their use.
Patient reported outcome measures in both groups were favor-
able indicating a high patient acceptance of treatment. While the
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
14      HEITZ-­MAYFIELD et al.

F I G U R E 6  Mean deepest probing depth, percentage of plaque present, number of sites with bleeding on probing and number of sites
with suppuration from baseline to 12 months post-­surgery. (a) Mean deepest probing depth. (b) Mean percentage of plaque present across 4
sites (distal, buccal, mesial and lingual). (c). Mean number of sites with bleeding on probing present (4 sites distal, buccal, mesial and lingual).
(d). Mean number of sites with suppuration present (4 sites, distal, buccal, mesial and lingual).

participants in this study were not required to pay for the treat-
ment received it should be emphasized that the financial costs for
the patient are greater with a reconstructive approach due to the
costs of the regenerative materials used. Therefore, the long-­term
treatment outcomes should be evaluated in a cost-­effectiveness
analysis.
4.1  |  Limitations of the study
It is understood that a sample of 40 participants is relatively small;
however, this was deemed manageable for a single center enrolling
patients to be treated within a reasonable time period. It has been
suggested that multicenter trials should be designed to increase the
sample size. Furthermore, the sample size calculation was made
based on PD changes and it may be argued that a composite out-
come variable would be more appropriate. As there was limited in-
formation available regarding the ideal composite outcome variable
at the time of designing the study it was decided to use the pri-
mary outcome of PD change. It is also recognized that the standard
deviation of 0.5 used in the a priori sample size calculation is smaller
than what was obtained, raising the possibility of an underpowered
study.
It is also recognized that evaluation of bone regeneration on a
radiograph following placement of a radiopaque graft material in
the intraosseous defect may be difficult (Jepsen et al., 2016). In the
present study two experienced oral and maxillofacial radiologists,
blinded to the treatment group allocation and to the time point, as-
sessed the radiographs to minimize bias. Furthermore, the radiolo-
gists evaluated the radiographs by consensus and the reliability of
repeated measurements was found to be excellent.
The difficulty in visualizing the marginal bone levels on the
cone beam CT scans in this study, due to substantial artefact, sug-
gests that the intraoral periapical radiograph remains the stan-
dard of care for evaluating marginal bone levels at implants, while
recognizing the limitation of being unable to view the buccal and
oral aspects.
A further limitation was that this study was conducted during the
time of COVID-­19 restrictions and some scheduled appointments
for some patients were delayed by several weeks.
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
HEITZ-­MAYFIELD et al.       15

20

18

16

14

12
Count

10

0
Control Test Control Test Control Test Control Test Control Test
Baseline Baseline 3 months 3 months 6 months 6 months 9 months 9 months 12 months 12 months
PD <5mm 0 0 16 17 15 17 17 17 18 18
PD 5-6 mm 4 11 3 2 4 2 2 1 2 1
PD >6mm 16 9 1 1 1 1 1 1 0 1

F I G U R E 7  Comparison of probing depths <5 mm, 5–­6 mm and >6 mm at each timepoint for control and test groups.

F I G U R E 8  Patient reported pain, appearance, disruption to daily activity and satisfaction scores between control and test groups.
Outcomes were scored on a Visual Analogue scale (0–­100 mm).

5  |   CO N C LU S I O N approach using a xenograft (DBBM) covered by a resorb-

able collagen membrane achieve successful clinical and radio-
In the presence of a contained (3-­o r 4-­w all) intraosseous graphic outcomes with a high level of patient satisfaction at
peri-­i mplantitis defect both access flap and a reconstructive 12 months.
 | 16     

TA B L E 5  Composite outcome success scores (n = 40) using composite success criteria as reported in published studies.

Total success Control success Test success Between group

Reference study Composite outcome success criteria f (%) f (%) f (%) differences χ 2 (p-­value)

Heitz-­Mayfield et al. (2018) • Absence of PD ≥ 5 mm with BOP 35 (87.5) 18 (90.0) 17 (85.0) 0.2 (1.000)
• Absence of suppuration all sites
• Absence of progressive bone loss
Jepsen et al. (2016) • Absence of progressive bone loss 23 (57.5) 11 (55.0) 12 (60.0) 0.1 (1.000)
• PD ≤ 4 mm
• Absence BOP at all sites
• Absence of suppuration all sites
Renvert et al. (2018) • Defect fill ≥1 mm (bone fill) 19 (47.5) 8 (40.0) 11 (55.0) 0.9 (.527)
• PD values at implant ≤5 mm
• Absence BOP all sites
• Absence suppuration all sites
Derks, Ortiz-­V igon, et al. (2022) and • Absence of BOP all sites 19 (47.5) 9 (45.0) 10 (50.0) 0.10 (1.000)
Regidor et al. (2023) • Absence of SOP all sites
• PD ≤5 mm
• ≤1 mm recession of mucosal margin on the buccal aspect
Proposed novel composite success • PD ≤ 4 mm 17 (42.5) 7 (35.0) 10 (50.0) 0.92 (.523)
criteria • absence BOP all sites
• absence suppuration all sites
• Increase in marginal bone level of ≥1 mm at deepest site
• Buccal mucosal recession ≤1 mm OR patient reported success
satisfaction with appearancea

Abbreviations: BOP bleeding on probing; PD probing depth.

a
Patient reported success was determined as no change or improvement in visual analogue scale for satisfaction with appearance as compared to baseline.
HEITZ-­MAYFIELD et al.

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

HEITZ-­MAYFIELD et al.
AU T H O R C O N T R I B U T I O N S
LHM and FH contributed to study design and conception. LHM, FH
collected the data. BK and TH analyzed the radiographs. LHM, FH,
BK and PC contributed to the data analysis and data interpretation.
LHM led the writing of the manuscript and all authors contributed to
the revision of the manuscript.
AC K N OW L E D G M E N T S
This study was funded by a research grant from the Osteology
Foundation (Grant Nr. 14-­075). Open access publishing facilitated
by The University of Western Australia, as part of the Wiley -­ The
University of Western Australia agreement via the Council of
Australian University Librarians.
C O N F L I C T O F I N T E R E S T S TAT E M E N T
L.J.A. Heitz-­Mayfield reports speaking honoraria from the Osteology
Foundation, ITI Foundation, Geistlich Pharma AG, Straumann Group.
Authors F Heitz, B Koong, T Huang and P Chivers report no conflicts
of interest.
DATA AVA I L A B I L I T Y S TAT E M E N T
Data are available on reasonable request to the corresponding
author.
ORCID
Lisa J. A. Heitz-­Mayfield  https://orcid.org/0000-0001-5755-8265
Paola Chivers  https://orcid.org/0000-0003-2278-4857
REFERENCES
Abrahamsson, K. H., Wennstrom, J. L., Berglundh, T., & Abrahamsson,
I. (2017). Altered expectations on dental implant therapy; views
of patients referred for treatment of peri-­implantitis. Clinical
Oral Implants Research, 28(4), 437–­4 42. https://doi.org/10.1111/
clr.12817
Berglundh, T., Armitage, G., Araujo, M. G., Avila-­Ortiz, G., Blanco,
J., Camargo, P. M., Chen, S., Cochran, D., Derks, J., Figuero, E.,
Hämmerle, C. H. F., Heitz-­Mayfield, L. J. A., Huynh-­Ba, G., Iacono,
V., Koo, K. T., Lambert, F., McCauley, L., Quirynen, M., Renvert,
S., … Zitzmann, N. (2018). Peri-­implant diseases and conditions:
Consensus report of workgroup 4 of the 2017 world workshop on
the classification of periodontal and Peri-­implant diseases and con-
ditions. Journal of Clinical Periodontology, 45(Suppl 20), S286–­S291.
https://doi.org/10.1111/jcpe.12957
Carcuac, O., Derks, J., Charalampakis, G., Abrahamsson, I., Wennström,
J., & Berglundh, T. (2016). Adjunctive systemic and local antimicro-
bial therapy in the surgical treatment of peri-implantitis: A random-
ized controlled clinical trial. Journal of dental research, 95(1), 50–­57.
https://doi.org/10.1177/00220​3 4515​601961
Dahlin, C., Linde, A., Gottlow, J., & Nyman, S. (1988). Healing of bone
defects by guided tissue regeneration. Plastic and Reconstructive
Surgery, 81(5), 672–­676. https://doi.org/10.1097/00006​534-­19880​
5000-­0 0004
Derks, J., Ichioka, Y., Dionigi, C., Trullenque-­Eriksson, A., Berglundh, J.,
Tomasi, C., & Graziani, F. (2022). Prevention and management of
peri-­implant mucositis and peri-­implantitis: A systematic review
of outcome measures used in clinical studies in the last 10 years.
Clinical Oral Implants Research, 34 Suppl 25, 55–­67. https://doi.
org/10.1111/clr.13925
|
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
      17
Derks, J., Ortiz-­V igon, A., Guerrero, A., Donati, M., Bressan, E., Ghensi,
P., Schaller, D., Tomasi, C., Karlsson, K., Abrahamsson, I., Ichioka,
Y., Dionigi, C., Regidor, E., & Berglundh, T. (2022). Reconstructive
surgical therapy of peri-­implantitis: A multicenter randomized con-
trolled clinical trial. Clinical Oral Implants Research, 33, 921–­944.
https://doi.org/10.1111/clr.13972
Heitz-­Mayfield, L. J., Salvi, G. E., Mombelli, A., Faddy, M., Lang,
N. P., & Group, I. (2012). Anti-­infective surgical therapy
of peri-­implantitis. A 12-­month prospective clinical study.
Clinical Oral Implants Research, 23(2), 205–­210. https://doi.
org/10.1111/j.1600-­0501.2011.02276.x
Heitz-­Mayfield, L. J. A., Salvi, G. E., Mombelli, A., Loup, P. J., Heitz, F.,
Kruger, E., & Lang, N. P. (2018). Supportive peri-­implant therapy
following anti-­infective surgical peri-­implantitis treatment: 5-­year
survival and success. Clinical Oral Implants Research, 29(1), 1–­6.
https://doi.org/10.1111/clr.12910
Isehed, C., Svenson, B., Lundberg, P., & Holmlund, A. (2018). Surgical
treatment of peri-­implantitis using enamel matrix derivative, an
RCT: 3-­ and 5-­year follow-­up. Journal of Clinical Periodontology,
45(6), 744–­753. https://doi.org/10.1111/jcpe.12894
Jepsen, K., Jepsen, S., Laine, M. L., Anssari Moin, D., Pilloni, A., Zeza,
B., Sanz, M., Ortiz-­V igon, A., Roos-­Jansåker, A. M., & Renvert, S.
(2016). Reconstruction of Peri-­implant osseous defects: A multi-
center randomized trial. Journal of Dental Research, 95(1), 58–­66.
https://doi.org/10.1177/00220​3 4515​610056
Jepsen, S., Schwarz, F., Cordaro, L., Derks, J., Hammerle, C. H. F.,
Heitz-­M ayfield, L. J., Meijer, H. J. A., Naenni, N., Ortiz-­V igón,
A., Pjetursson, B., Raghoebar, G. M., Renvert, S., Rocchietta,
I., Roccuzzo, M., Sanz-­S ánchez, I., Simion, M., Tomasi, C.,
Trombelli, L., & Urban, I. (2019). Regeneration of alveolar ridge
defects. Consensus report of group 4 of the 15th European
workshop on periodontology on bone regeneration. J Clin
Periodontol, 46(Suppl 21), 277–­2 86. https://doi.org/10.1111/
jcpe.13121
Karlsson, K., Derks, J., Hakansson, J., Wennstrom, J. L., Petzold, M., &
Berglundh, T. (2019). Interventions for peri-­implantitis and their
effects on further bone loss: A retrospective analysis of a registry-­
based cohort. Journal of Clinical Periodontology, 46(8), 872–­879.
https://doi.org/10.1111/jcpe.13129
Khoshkam, V., Chan, H. L., Lin, G. H., MacEachern, M. P., Monje, A.,
Suarez, F., Giannobile, W. V., & Wang, H. L. (2013). Reconstructive
procedures for treating peri-­implantitis: A systematic review.
Journal of Dental Research, 92(12 Suppl), 131S–­138S. https://doi.
org/10.1177/00220​3 4513​509279
Koo, T. K., & Li, M. Y. (2016). A guideline of selecting and reporting
Intraclass correlation coefficients for reliability research. Journal
of Chiropractic Medicine, 15(2), 155–­163. https://doi.org/10.1016/j.
jcm.2016.02.012
Regidor, E., Ortiz-­Vigon, A., Romandini, M., Dionigi, C., Derks, J., & Sanz,
M. (2023). The adjunctive effect of a resorbable membrane to a xe-
nogeneic bone replacement graft in the reconstructive surgical ther-
apy of peri-­implantitis–­a randomized clinical trial. Journal of Clinical
Periodontology, 50, 765–­783. https://doi.org/10.1111/jcpe.13796
Renvert, S., Giovannoli, J. L., Roos-­Jansaker, A. M., & Rinke, S. (2021).
Surgical treatment of peri-­implantitis with or without a deprotein-
ized bovine bone mineral and a native bilayer collagen membrane:
A randomized clinical trial. Journal of Clinical Periodontology, 48(10),
1312–­1321. https://doi.org/10.1111/jcpe.13513
Renvert, S., Roos-­Jansaker, A. M., & Persson, G. R. (2018). Surgical treat-
ment of peri-­implantitis lesions with or without the use of a bone sub-
stitute-­a randomized clinical trial. Journal of Clinical Periodontology,
45(10), 1266–­1274. https://doi.org/10.1111/jcpe.12986
Roos-­Jansaker, A. M., Persson, G. R., Lindahl, C., & Renvert, S. (2014).
Surgical treatment of peri-­implantitis using a bone substitute with or
without a resorbable membrane: A 5-­year follow-­up. Journal of Clinical
Periodontology, 41(11), 1108–­1114. https://doi.org/10.1111/jcpe.12308
 |

16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
18      HEITZ-­MAYFIELD et al.

Roos-­Jansaker, A. M., Renvert, H., Lindahl, C., & Renvert, S. (2007).

Surgical treatment of peri-­implantitis using a bone substitute with S U P P O R T I N G I N FO R M AT I O N
or without a resorbable membrane: A prospective cohort study. Additional supporting information can be found online in the
Journal of Clinical Periodontology, 34(7), 625–­632. https://doi. Supporting Information section at the end of this article.
org/10.1111/j.1600-­051X.2007.01102.x
Schulz, K. F., Altman, D. G., Moher, D., & Group, C. (2011). CONSORT
2010 statement: Updated guidelines for reporting parallel group
randomised trials. International Journal of Surgery, 9(8), 672–­677.
How to cite this article: Heitz-­Mayfield, L. J. A., Heitz, F.,
https://doi.org/10.1016/j.ijsu.2011.09.004
Schwarz, F., Sahm, N., Schwarz, K., & Becker, J. (2010). Impact of defect Koong, B., Huang, T., & Chivers, P. (2023). Surgical peri-­
configuration on the clinical outcome following surgical regenerative implantitis treatment with and without guided bone
therapy of peri-­implantitis. Journal of Clinical Periodontology, 37(5), regeneration. A randomized controlled trial. Clinical Oral
449–­455. https://doi.org/10.1111/j.1600-­051X.2010.01540.x
Implants Research, 00, 1–19. https://doi.org/10.1111/
Tomasi, C., Regidor, E., Ortiz-­V igon, A., & Derks, J. (2019). Efficacy of
reconstructive surgical therapy at peri-­implantitis-­related bone clr.14116
defects. A systematic review and meta-­analysis. Journal of Clinical
Periodontology, 46(Suppl 21), 340–­356. https://doi.org/10.1111/
jcpe.13070

APPENDIX 1
Question. How satisfied are you with the appearance of your implant restoration?

0 100

Not at all Completely

satisfied satisfied

Question. How painful was the procedure?

0 100

Not painful at all Worst pain

imaginable

Question. During the first week after the surgery how much pain did you experience?

0 100

Not painful at all Worst pain

imaginable

Question. During the first week how did the treatment at your implant affect your normal daily activities?

0 100

Not at all Unable to perform

normal daily activities
16000501, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/clr.14116 by Readcube (Labtiva Inc.), Wiley Online Library on [30/06/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
|      19

Question. If you had known you would need to have the peri-­implantitis treatment would you have still chosen to have an implant?

Definitely yes

Completely
satisfied
100
100

Question. How satisfied are you with the appearance of your implant restoration?
Definitely not

0
0

Not at all
satisfied
HEITZ-­MAYFIELD et al.