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Radiographic assessment of crestal bone loss in tissue-level implants restored by platform matching

compared with bone-level implants restored by platform switching: A randomized, controlled,

split-mouth trial with 3-year follow-up

Laura Lago, DDS, PhD1

Luis da Silva, MD, PhD1

Isabel Martinez-Silva, PhD2

Benito Rilo, MD, PhD1

1
Department of Prosthodontics, Faculty of Medicine and Dentistry, Santiago de Compostela

University, Santiago de Compostela, Spain.

2
Department of Statistics, University of Vigo Biomedical Research Centre, Vigo, Spain.

Corresponding author:

Dr. L. Lago

Department of Prosthodontics, Faculty of Medicine and Dentistry

Santiago de Compostela University

Entrerríos, s/n, 15782 Santiago de Compostela, Spain

e-mail: lagogonzalezlaura@gmail.com

+34 881 812 349

Submitted February 5, 2018; Accepted June 14, 2018.

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Purpose: This randomized, controlled, split-mouth trial with 3-year follow-up was carried out to compare

radiologic changes of crestal bone level (CBL) between splinted tissue-level implants restored by

platform matching and bone-level implants restored by platform switching. Materials and Methods:

Periapical radiographs were taken to evaluate the peri-implant crestal bone changes at baseline (implant

restoration), at 1 year, and at 3 years after the definitive restoration. Results: Thirty-five patients

requiring a partial fixed dental prosthesis supported by two implants had their sites randomized according

to receiving both implant types. Fifty tissue-level implants restored by platform matching, as control

implants, and 50 bone-level implants restored by platform switching, as test implants, were placed.

Crestal bone changes in the control group were: baseline to 3 years, 0.18 ± 0.46 mm (P = .043). In the test

group, crestal bone changes were: baseline to 3 years, 0.14 ± 0.35 mm (P = .514). The mean differences

between groups were: baseline to 1 year, 0.07 ± 0.23 mm (95% CI: –0.034, 0.185); 1 to 3 years, 0.01 ±

0.01 mm (95% CI: –0.055, 0.074); baseline to 3 years, 0.04 ± 0.11 mm (95% CI: –0.080, 0.150). No

statistically significant differences in CBL at baseline to 1 year (P = .269), 1 year to 3 years (P = .811),

and baseline to 3 years (P = .513) were observed. Conclusion: In this trial, CBL changes in the tissue-

level control group were statistically significant only between baseline and 3-year follow-up. Meanwhile,

CBL changes in the bone-level test group were not statistically significant in the different times studied.

No statistically significant difference in CBL between two implant types was observed. Int J Oral

Maxillofac Implants 2018. doi: 10.11607/jomi.6954

Keywords: platform switching, split-mouth, bone level implant, tissue level implant, marginal bone loss.

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Maintenance of the peri-implant bone crest and stable soft tissue contours are prerequisites for a long-

term success in implant treatment.1 After healing abutment connection and delivery of the final

prostheses, crestal bone remodeling and bone resorption take place. The re-establishment of an

appropriate peri-implant biologic width to protect the osseointegration has been proposed as one of the

main causes of early bone loss.2 However, peri-implant bone loss could be affected by several factors,

such as surgical trauma during implant insertion,3 infection,4,5 occlusal overload,6,7 implant characteristics

at the neck region in contact with the bone,8-10 implant–abutment design,11-13 and position of the

microgap.14,15 Therefore, the amount of crestal bone resorption over time depends on a combination of all

of these factors. The well-known platform-switching concept introduced by Gardner16 and Lazzara &

Porter17 suggested that a reduction in the mismatch between implant-abutment seemed to reduce crestal

bone loss, compared to standard platform-matched implants.18 Subsequently, several studies have found

that both hard and soft tissues have a favorable clinical response to the platform-switching concept.19-25

The most recent systematic reviews and meta-analyses in the literature26-31 are focused on clarifying the

usefulness of implants restored according to the platform-switching concept and their effect on hard and

soft tissue preservation. Although most of them have shown favorable outcomes of the platform-

switching system, some studies reported that there were no differences between the two implant types,

and others reported unfavorable results.32-35 Another important consideration is that long-term follow-ups

were reported for very few studies.18, 23-25, 37, 38

Furthermore, not many split-mouth studies have been

performed in which outcomes concerning the effectiveness of platform-switching after mid– to long-term

follow-up was reported.39-42

The aim of the present trial was to evaluate the peri-implant crestal bone level changes between

tissue-level implant restored with platform matching (control implants) versus a bone level implant

restored with platform switching (test implants) after 3 years of follow-up when placed together in the

same anatomical region following a split-mouth design.

MATERIALS AND METHODS

This randomized, controlled, trial following a split-mouth design was carried out in the Prosthodontic

Unit, Faculty of Medicine and Dentistry at the University of Santiago de Compostela, Spain, using

partially edentulous subjects referred to this department for rehabilitation treatment in the posterior

region. This study was prepared in accordance with the guidelines outlined in the CONSORT statement

(http://www.consort-statement.org).43 A copy of the checklist has been included.

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Inclusion criteria

The inclusion requirements were: patients requiring dental rehabilitation with two implants for two

splinted crowns or a short-fixed prosthesis (one pontic); patients age of at least 20 years; a minimum of 6

months’ healing since any prior tooth loss; all edentulous areas located in the posterior area and with a

natural tooth on both side of the gap; at least 6 mm of bone in horizontal dimension and at least 8 mm of

bone in vertical dimension, no bone grafts and/or membranes; bone types II and III;44 at least 4 mm of

keratinized gingiva; full-mouth bleeding score and full-mouth plaque score <25%; and natural teeth or

fixed restoration in the opposite arch.

Exclusion criteria

The exclusion criteria were: bone types I and IV;44 bruxism or temporomandibular disorders (TMD)

symptoms; signs of active periodontitis; poor oral hygiene; unsuccessful previous implant treatment at the

intervention area; smoking habits (>10 cigarettes/day), and current substance abuse, and pharmacotherapy

contraindications for implant surgery.

Study design and sample size calculation

Using results obtained in a previous study45, considering a difference of 0.5 mm between tissue-level

control group and bone-level test group in mean crestal bone changes (SD=0.66 in control group and

SD=0.9 in test group) assuming 98% power, a 5% significance level, and a correlation between groups of

0.407 with 95% IC (0.226-0.560), the sample size required was 50 paired data (implants).

A split-mouth trial was performed in the posterior area where tissue-level implant, as control group, and

bone-level implants, as test group, were placed according to a randomization procedure. All patients

recruited signed an informed consent. The study protocol was designed in accordance with the revised

Declaration of Helsinki of 199746 and approved by the Research Ethics Committee at the University of

Santiago de Compostela.

Randomization

Each patient will receive, at least, a bone level implant (as test implant) and a tissue level implant (as

control implant) in the same quadrant in posterior area. The mesial implant position, selected according to

predefined randomization tables, was assigned and performed by a statistician. The assignment was

performed by an independent examiner, who received a sealed opaque envelope with the corresponding

position for the implant that would be located in the mesial position immediately before bone preparation.

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The examiner did not participate in the surgery or examination. Due to the nature of the treatment, the

surgeon was aware of the type of implant and the location.

Clinical Procedures

Surgery and prosthetic procedures were performed according to established protocols.47 Patients received

a bone volume analysis using cone beam computed tomography (CBCT). All patients recruited received

amoxicillin (1 g) and clavulanic acid (250 mg) from 1 hour before surgery to 8 days after surgery

(500/125 mg, twice a day). Local anesthesia was induced using articaine with epinephrine (1:200.000;

Artinibsa, Barcelona, Spain). All implants were placed using a supracrestal at midcrestal level incision.

Appropriate drills were used to prepare the implant site according to the implant type. The distance of the

implant to the adjacent teeth was 1.5 mm, and at least 3 mm between two implant types. Healing

abutments were connected at the time of surgery. A sterile surgical silk 4-0 sutures (LorcaMarín, Murcia,

Spain) were used for suturing the flaps. Healing caps were left uncovered. Periapical radiographs were

taken. All subjects were provided with oral hygiene instruction. Two weeks after surgery, the sutures

were removed. When osseointegration was concluded (at least 2 months after implant placement),

prosthetic rehabilitation began at the same time for both implant types, using the appropriate components

for each one. Final restorations, consisting of two crowns or a short span were splinted, were cemented

(Panavia F Kuraray Medical Inc., Okayama, Japan). In each revision, soft tissues were clinically

evaluated according plaque index, bleeding index, and probing pocket depth.

Radiographic assessment

Crestal bone level changes by periapical radiographs (Kodak Ultraspeed Dental Film; Eastman Kodak,

Rochester, NY, USA), were assessed with the dental radiology system Siemens Heliodent model X1744

MD set at 70 kV and 7 mA (Sirona Dental System GmbH, Bensheim, Germany). Radiographs were taken

according to the long-cone, paralleling technique, using a positioner (X-ray Holders KerrHawe SA,

Bioggio, Switzerland) with a bite registration (Aquasil Soft Putty/Regular Set, Dentsply DeTrey GmbH,

Konstanz, Germany). The accuracy of this technique showed a precision value of 0.44 mm.45 Each

radiograph was photographed by a Nikon D1 Digital Reflex camera with Macro 100 mm type F (Nikon

Medical Objective, Nikon Corp, Tokyo, Japan). A reproducible source of light was applied using a

Circular Macro Speedlight flash SB-29 (Nikon,). Each photograph was processed in a Hewlett Packard

processor (Intel® CoreTM Duo, InsideTM, Hewlett Packard Corp, Palo Alto, CA, USA). Images were

processed with software NIH ImageJ (Wayne Rasband, National Institutes of Health, Bethesda, MD,

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USA). Taken as reference point the distance from the implant shoulder to the first bone-to-implant

contact (DIB)48, 49
, measurements were performed at mesial and distal sites (Fig. 1). Three observers

defined landmarks. If all three opinions differed, the landmarks were considered too difficult to measure

and so were discarded from the study.

Statistical analysis

Taking as statistical unit single implant to compare the DIB values in bone-level implants and in tissue-

level implants respectively, in the three times studied (baseline-1 year-3 year) the Kruskal–Wallis and the

Mann–Whitney tests were used. As the first approximation to the model, the analysis of the DIB values

was determined by repeated measures ANOVA and the Bonferroni post-hoc test was used for the time

factor. To calculate the value of crestal bone level (CBL) in the different interval times between implant

test and implant control, mixed model analyses was used. Changes score baseline-1 year and baseline-3

year between tissue level and bone level implants, F-Snedecor, p-value and effect sixe (n2p) were

compared with an analysis of covariance (ANCOVA). Differences between implants were considered

significant at p < 0.05. Statistical analysis of the data was performed using the R software (R Core Team

[2016]).

RESULTS

In total, 123 patients were screened for eligibility, 35 subjects were incorporated in the trial (15 males and

20 females) between the ages of 25 and 70 years (mean 49.5 years). A number of 88 patients were

excluded for the following reasons: 43 patients did not want to participate in a clinical trial, 19 subjects

were under treatment with oral bisphosphonates, 5 patients due to poor oral hygiene, 10 patients were

heavy smokers, 6 patients for periodontitis and 5 patients with TMD. No patients were lost during the

course of the study. Patients were recruited between January 2012 to June 2012, and implants were placed

from July 2012 to December 2012. Data were collected at baseline, in December 2013 (1-year), and in

December 2015 (3-year). Of the 35 patients recruited, 22 patients received a pair of implants in one

quadrant. 10 patients received two pairs of implants in two quadrants. 2 patients received three pairs of

implants in three quadrants and 1 patient received four pairs of implants in the four quadrants. Each pair

of implants consisted of a bone-level implant and a tissue-level implant. Bone-level implants (as test

group) and tissue-level implants (as control group) were compared at baseline (implant restoration), at 1-

year, and at 3-year.

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(1) Implant control group. A total of 50 implants of the Standard Plus Type model (Institut Straumann

AG, Waldenburg/SP, Switzerland).

(2) Implant test group. A total of 50 implants, of the Bone Level Type model (Institut Straumann AG,

Waldenburg/SP, Switzerland). Implant distribution is shown in Table 1.

Patients were followed up to 3-year. Clinical assessment was <25% in all cases, and probing pocket depth

did not exceed 3 mm. Mean scores of the indices were very low and no differ between the groups (Table

2). There were not implant failures in both groups and no complications were reported during the course

of the study (Fig. 2).

Radiographic changes

Outcomes for DIB in control group were: at baseline, 1.78 ± 0.21 mm; at 1 year, 1.94 ± 0.54 mm; at 3

years, 1.96 ± 0.52 mm. Mesial and distal values for DIB in tissue level implants and changes score

between times are showed in Table 3. For CBL values: baseline–1 year, 0.15 ± 0.49 mm (p = 0.052); 1–3

years, 0.07 ± 0.23 mm (p = 0.237); baseline–3 years, 0.18 ± 0.46 mm (p = 0.043).

Outcomes for DIB in test group were: at baseline, 0.27 ± 0.52 mm; at 1 year, 0.35 ± 0.59 mm; at 3 years,

0.42 ± 0.65 mm. Mesial and distal values for DIB in bone level implants and changes score between times

are showed in Table 3. CBL values were: baseline–1 year, 0.08 ± 0.26 mm (p = 0.081); 1–3 years, 0.06 ±

0.22 mm (p = 0.514); baseline–3 years, 0.14 ± 0.35 mm (p = 0.102). The mean differences between

control and test group were: baseline–1 year, 0.07 ± 0.23 mm (95% IC: -0.034, 0.185); 1–3 years, 0.01 ±

0.01 mm (95% IC: -0.055, 0.074); baseline–3 years, 0.04 ± 0.11 mm (95% IC: -0.080, 0.150). No

statistically significant differences in CBL were found at baseline-1 year (p = 0.269), 1 year-3 year (p =

0.811), and baseline-3 year (p = 0.513) (Table 4).

DISCUSSION

The platform-switching configuration has previously been reported in the literature. Although some

studies have reported that there were no differences between the two implant configurations and others

found unfavorable results,32-35 several systematic reviews reported favorable outcomes in terms of bone

stability and soft tissue maintenance. Atieh et al.26 in their systematic review and meta-analysis involving

a total of 10 RCTs, concluded significantly lower bone loss in platform switching group (MD: -0.37 mm).

Annibali et al.27 in their systematic review with a follow-up of no longer than 36 months, reported no

differences in implant success rate between platform matching and platform switching (0–2.02 mm vs. 0–

0.99 mm). Strietzel et al.28 reported that most studies analyzed in their systematic review and meta-

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analysis showed more favorable results for platform switching. Likewise, Herekar et al.29 showed better

performance for platform switching (mean difference: −0.34 mm). The same findings were reported by

Chrcanovic et al.30 (MD: −0.29 mm) and the most recent systematic review by Santiago et al.31 (MD:

−0.41 mm).

The present trial was focused to elucidate evidence-based data available in the literature. The study

follows a split-mouth design, where comparisons are made on a within patient not a between-patient

basis. A potential advantage of this design is that the patient serves as his/her own control, which can

increase statistical efficiency.50 In this study, posterior edentulous regions were selected for placing

implants simultaneously in the same anatomical region, using two types of implants with different

prosthetic abutments. This implies not only that the surgical protocol will be similar, but also the healing

conditions and maintenance of oral hygiene levels will be equal. Likewise, the transmission of the loads

will also be very similar because the crowns are splinted; a factor that could not be considered if a classic

contralateral design was used. In this study the loads cannot be randomized, but the possible bias that

represents the different occlusal loads on the implants were minimized. Split-mouth studies applied to the

field of implant dentistry are less frequent, and most of them have been used to analyze different surgical

techniques51-53 (submerged versus. non-submerged); prosthetic loading received54 (immediate versus

conventional); or different implant configuration and connection types55,56 (external versus internal).

Publications concerning the type of platform used are fewer. Telleman et al.39 used a split-mouth study to

evaluate radiographically peri-implant bone changes between implants restored by platform matching

(control implants) and implants restored by platform switching (test implants) randomly located on either

side of the posterior maxilla. After 1 year of functional loading, test implants showed 0.53 ± 0.54 mm and

control implants 0.85 ± 0.65 mm (p = 0.003). However, it is important to note that the differences

between the two implant types were only statistically significant when the comparison was made between

two or more implants, but not in cases of single restorations. Vandeweghe & De Bruyn40 radiographically

assessed crestal bone changes around 15 implants of 7 mm diameter, placed in the posterior jaw and

restored with an abutment located in an eccentric position in relation to the implant axis. After 12-months

follow-up, outcomes were 0.94 ± 0.42 mm for platform matched and 0.66 ± 0.47 mm for platform

switched (p = 0.002). The differences were only significantly when the mucosal thickness was higher than

4.22 mm. This suggests that the benefit of the platform modification is apparent when there is enough

thickness of the mucosa. Meloni et al.35 analyzed radiographic changes in both implant types in 18

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patients (36 implants) following a split-mouth design. After 1-year follow-up, no differences were

observed between the two groups (0.56 ± 0.22 mm vs. 0.50 ± 0.27 mm; p = 0.38). The only difference

between the implant control and implant test groups in this study was the platform type used. Pozzi et al.41

analyzed crestal bone changes of two implant types with different prosthetic interfaces and different neck

configurations placed in the posterior jaw. Implants with platform switching showed better radiological

outcomes than implants with platform matched between baseline and 1 year (0.51 ± 0.34 mm vs. 1.10 ±

0.52 mm, respectively). The same authors42 after 3 years, reported that implants with platform switching

offered a bone loss of 0.66 ± 0.39 mm, and 1.25 ± 0.47 mm for implants restored by platform matching.

Esposito et al.55 evaluated advantages and disadvantages of 154 implants with internal connection and

platform switched abutments and 173 implants with external connection and platform matched. The

authors reported no differences between both groups (difference = 0.24 mm, p = 0.062). The same

authors published a new randomised controlled trial with 5-year follow-up about advantages and

disadvantages of 107 implants with platform switched abutments and internal connection and 96 implants

with platform matched and external connection. After 5-year post-loading, Esposito et al.56 concluded that

there were no statistically significant differences in crestal bone level changes between both groups

(difference = 0.14 mm, p = 0.505). It should be noted that the authors analyzed two identical implants

placed at the bone level with external/internal connection and different platform type. Although the

characteristics of the implants differed between connection types, their results for comparison purposes

were the same as the present study.

In the present trial, both implant types showed good outcomes regarding maintenance of crestal bone

level with no statistically significant differences at 3 years of follow-up. It should be noted that in the

literature it is not possible to find other studies with the same implant system, follow-up period and

methodology used in the present trial, making it difficult to establish comparisons. It is also important to

note that the results obtained must be interpreted with caution. The differences in the maintenance of bone

levels between one system and another are minimal; therefore, they could have little clinical relevance.

Thus, the advantages offered by each implant type due to other features such as emergency profile may be

more important than maintenance of the bone level. Since most commercial systems offer several types of

implants at tissue and bone level, we believe that the external validity of the study may be useful to the

dentist when making clinical decisions.

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The main limitations of the present trial were: implant-abutment design was different between the two

implants evaluated; due to strict inclusion criteria, the study could have a little external validity; many

patients received more than a pair of two implant types in different edentulous areas, and to assess bone

quality with CBCT could be challenge.

CONCLUSION

In the present trial, crestal bone level changes in tissue-level control group were statistically significant

only between baseline and 3-year follow-up. Meanwhile, crestal bone level changes in bone-level test

group were not statistically significant in different times studied. No statistically significant difference in

CBL between two implant types was observed.

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Table 1. Implant distribution. Tissue level (TL) and Bone level (BL)

MAXILLA

2nd MOLAR 1st MOLAR 2nd PREMOLAR 1st PREMOLAR

TL 7 15 2 2

BL - 6 8 12

Total 7 21 10 14

MANDIBULAR

2nd MOLAR 1st MOLAR 2nd PREMOLAR 1st PREMOLAR

TL 15 8 1 -

BL 1 10 7 6

Total 16 18 8 6

Table 2. Clinical parameters for tissue level (TL) and bone level (BL) implants.

BL IMPLANTS BASELINE 1 YEAR 3 YEAR

mean ± SD mean ± SD mean ± SD

Plaque index 0.2 ± 0.5 0.10 ± 0.2 0.4 ± 0.8

(0-3)
Sulcus bleeding index 0.05 ± 0.6 0.2 ± 0.5 0.3 ± 0.3
(0-3)
Pocket probing depth 1.7 ± 0.7 mm 2.2 ± 0.5 mm 2.2 ± 0.6 mm
(mm)

TL IMPLANTS BASELINE 1 YEAR 3 YEAR

mean ± SD mean ± SD mean ± SD

Plaque index 0.4 ± 0.6 0.2 ± 0.4 0.3 ± 0.5

(0-3)
Sulcus bleeding index 0.2 ± 0.3 0.2 ± 0.4 0.1 ± 0.4
(0-3)
Pocket probing depth 2.2 ± 0.4 mm 2.1 ± 0.6 mm 2.4 ± 0.5 mm
(mm)

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Table 3. DIB (mm) outcomes for tissue level (TL) and bone level (BL) implants at mesial and
distal sites.

TL implants BL implants F-Snedecor p-value Effect size

Mean Mean n p2
[IC 95%] [IC 95%]
Baseline mesial 1.77 mm 0.14 mm
[1.72-1.83] [0.04-0.23]

1-year mesial 1.94 mm 0.21 mm

[1.79-2.09] [0.08-0.33]

3-year mesial 1.94 mm 0.25 mm

[1.80-2.07] [0.11-0.38]

Change score 0.17 mm 0.07 mm 1.305 0.256 0.013

Baseline-1 year [0.02-0.31] [0.00-0.14]

Change score 0.17 mm 0.11 mm 0.553 0.459 0.006

Baseline-3 year [0.03-0.30] [0.03-0.19]

Baseline distal 1.80 mm 0.42 mm

[1.73-1.87] [0.24-0.59]

1-year distal 1.95 mm 0.51 mm

[1.78-2.11] [0.31-0.70]

3-year distal 2.00 mm 0.60 mm

[1.83-2.16] [0.38-0.82]

Change score 0.15 mm 0.09 mm 0.540 0.464 0.005

Baseline-1 year [0.02-0.28] [0.01-0.17]

Change score 0.20 mm 0.19 mm 0.017 0.896 <0.001

Baseline-3 year [0.07-0.33] [0.07-0.31]

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Table 4. CBL (mm) outcomes for tissue level (TL) and bone level (BL) implants at the three
interval times. Results for CBL at mesial (CBL m) and distal (CBL d) sites for tissue level (TL)
and bone level (BL) implants.

TIME CBL MEAN DIFFERENCE

INTERVAL MEAN ±SD ±SD

TL BL
0.15 ± 0.49 mm (p = 0.052) 0.08 ± 0.26 mm (p = 0.081) 0.07 ± 0.37 mm
Baseline – (p = 0.269)
1 year CBLm CBLd CBLm CBLd
0.16 ± 0.52 0.14 ± 0.46 0.07 ± 0.25 0.09 ± 0.28
mm mm mm mm

1 year – 0.07±0.23 mm (p =0.237) 0.06±0.22 mm (p =0.102) 0.01 ± 0.22 mm

3 years CBLm CBLd CBLm CBLd (p = 0.811)
0.04 ± 0.21 0.99 ± 0.25 0.03 ± 0.10 0.09 ± 0.30
mm mm mm mm

Baseline – 0.18±0.46 mm (p =0.043) 0.14±0.35mm (p =0.514) 0.04 ± 0.16 mm

3 years (p = 0.513)
CBLm CBLd CBLm CBLd
0.19 ± 0.46 0.19 ± 0.46 0.10 ± 0.27 0.18 ± 0.42
mm mm mm mm

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Figure legends

Figure 1. Reference points for measurement and periapical radiograph sequence through the times

studied.

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Figure 2. Flow chart.

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