Professional Documents
Culture Documents
Denis Cecchinato
Jorge Ferrus
clinical trial to evaluate bone
E. Bjarni Pjetursson preservation using implants with
Niklaus P. Lang
Jan Lindhe different geometry placed into
extraction sockets in the maxilla
Authors’ affiliations: Key words: controlled clinical trial, dental implants, extraction socket, immediate place-
Mariano Sanz, Jorge Ferrus, Postgraduate ment, implant geometry
Periodontology, Faculty of Odontology, University
Complutense of Madrid, Madrid, Spain
Denis Cecchinato, Institute Franchi, Padova, Italy Abstract
E. Bjarni Pjetursson, Niklaus P. Lang, Department
of Periodontology, School of Dental Medicine,
Aim: The primary objective of this study was to determine the association between the size
University of Berne, Berne, Switzerland of the void established by using two different implant configurations and the amount of
Jan Lindhe, Department of Periodontology, the buccal/palatal bone loss that occurred during 16 weeks of healing following their
Sahlgrenska Academy at Göteborg University,
Göteborg, Sweden installation into extraction sockets.
Material and methods: The clinical trial was designed as a prospective, randomized-
Correspondence to: controlled parallel-group multicenter study. Adults in need of one or more implants
Mariano Sanz replacing teeth to be removed in the maxilla within the region 15–25 were recruited.
Facultad de Odontologia
Following tooth extraction, the site was randomly allocated to receive either a cylindrical
Universidad Complutense
Plaza Ramon y Cajal (group A) or a tapered implant (group B). After implant installation, a series of
E-28040 Madrid measurements were made to determine the dimension of the ridge and the void between
Spain
Tel.: þ 34 91 34 1901 the implant and the extraction socket. These measurements were repeated at the re-entry
Fax: þ 34 91 394 1910 procedure after 16 weeks.
e-mail: marianosanz@odon.ucm.es
Results: The study demonstrated that the removal of single teeth and the immediate
placement of an implant resulted in marked alterations of the dimension of the buccal
ridge (43% and 30%) and the horizontal (80–63%) as well as the vertical (69–65%) gap
between the implant and the bone walls. Although the dimensional changes were not
significantly different between the two-implant configurations, both the horizontal and
the vertical gap changes were greater in group A than in group B.
Conclusions: Implant placement into extraction sockets will result in significant bone
reduction of the alveolar ridge.
documented that similar patterns of os- tions, mostly affecting the buccal bone Berne, Switzerland, Department of Perio-
seointegration occur in both humans (Wil- wall, may have significant adverse effects dontology, Universidad de Complutense,
son et al. 1998; Paolantonio et al. 2001) on the final esthetic result (Evans & Chen Madrid, Spain, Department of Perio-
and animals (Anneroth et al. 1985; Barzilay 2008). Some authors have attempted to coun- dontology, Institute of Odontology at
et al. 1996; Karabuda et al. 1999). How- teract this resorptive process by applying Sahlgrenska Academy, University of
ever, an experiment in dogs (Araújo et al. grafting materials or other bone-regenerative Gothenburg, Sweden, and Institute Franci,
2005) showed that Type 1 placement of techniques on the buccal bone wall (Covani Padova, Italy. The study protocol, as well
implants in post-extraction sockets was et al. 2004; Fugazzotto 2005). Results from as the informed consent forms, were ap-
associated with marked osteoclastic activ- recent clinical studies, however, demonstrate proved by the human review boards from
ity that resulted in dimensional alterations that in spite of using different regenerative the respective participating institutions.
(width and height) of the buccal and lingual approaches, buccal bone resorption occurs, This clinical trial was registered at
socket walls. although to a minor extent (Chen et al. (Clinicaltrials.gov.: http://clinicaltrials.gov/
In contrast, it was suggested that implant 2007). ct2/show/NCT00711282?term=NCT007
placement into an extraction socket may Tapered or root-shaped implants are fre- 11282&rank=1)
counteract the hard tissue resorption that quently used in Type 1 procedures. Such
occurs following tooth extraction (Denis- implants are designed with wide cone- Study population
sen et al. 1993; Watzek et al. 1995). The shaped marginal and narrower cylindrical Adult ( 18 years of age) subjects in need
validity of this hypothesis was questioned apical portions with the aim of filling the of one or more implants replacing teeth to
(Botticelli et al. 2004) in a clinical study, in space between the titanium rod and the be removed in the maxilla within region
which 21 implants were installed into ex- residual bone walls. Recent evidence from 15–25 were included if they fulfilled the
traction sockets in 18 patients. At surgical animal studies (Araújo et al. 2006), how- following criteria:
re-entry, after 4 months of healing, it was ever, has shown that the presence of a
found that most marginal gaps that were narrow space between the implant and Presence of at least 20 teeth with
present following implant placement were the severed socket wall may not prevent expected functional occlusion after
filled with newly formed hard tissue, but bone loss occurring following tooth extrac- restoration.
also that the buccal–lingual dimensions of tion. Hence, there is a risk that the surface Presence of an intact extraction socket
the ridge were markedly reduced (buccal of such wide implants may become ex- following removal of the natural tooth
450%, lingual about 30%). posed to the mucosa during healing and defined by:
Often the placement of an implant im- that this, in turn, may compromise treat- An anatomy suitable for both
mediately after tooth extraction is asso- ment outcomes. cylindrical and conical/cylindrical
ciated with a residual bone defect between The primary objective of this study was to implants.
the neck of the implant and the residual determine the association between the size A marginal border of the facial
bone walls. The use of barrier membranes of the void established by using two different bone crest that deviated 2 mm
and grafting materials has been proposed to implant configurations and the amount of from that of the expected normal
treat the residual peri-implant defects. The buccal/palatal bone loss occurring during location of the site/region.
rationale for the use of regenerative proce- healing following implant installation into A potential facial fenestration at
dures is to prevent the migration of cells extraction sockets. This was accomplished least 3 mm apical of the marginal
from the connective and epithelial tissues by determining alterations of the horizontal bone crest.
into the gap between the implant surface and vertical dimensions of the buccal and
Subjects were excluded if they indicated
and surrounding bone walls, thus favoring palatal void and surrounding bone structures
the presence of any of the following:
osteogenic cells in the bone-regenerative at placement and after initial healing (16
process (Paolantonio et al. 2001). The use weeks after implant placement). Untreated rampant caries and uncon-
of these regenerative materials has been trolled periodontal disease.
proposed depending on the size of this Absence of adjacent (mesial and/or dis-
residual bone defect, and several authors Material and methods tal) natural tooth root.
have recommended a threshold of 1–2 mm Uncontrolled diabetes or any other sys-
of horizontal gap between the implant sur- Study design temic or local disease or condition that
face and the buccal bone wall to indicate The study was designed as a prospective, would compromise post-operative heal-
the use of grafting or guided bone regenera- randomized-controlled parallel-group mul- ing and/or osseointegration.
tion (Chen et al. 2007; Lang et al. 2007). ticenter study documenting the response of Need for systemic corticosteroids or
The validity of this ‘critical dimension’ two implants with different configurations any other medication that would com-
has, however, never been demonstrated. in the treatment of subjects in need of one promise post-operative healing and/or
Moreover, because this technique is being or more single implants replacing teeth to osseointegration.
applied to the replacement of teeth in the be removed in the maxilla. Four centers are Unable or unwilling to return for fol-
maxillary anterior region, where esthetic involved in the current clinical study, low-up or unlikely to be able to comply
outcomes are of great importance (Kan namely, Department of Periodontology with study procedures according to in-
et al. 2003), these reported ridge altera- and fixed Prosthodontics, University of vestigators’ judgment.
14 | Clin. Oral Impl. Res. 21, 2010 / 13–21 c 2009 John Wiley & Sons A/S
Sanz et al Bone alterations after immediate implant installation
Smokers with a cigarette consumption diameters, 3.5, 4, 4.5 and 5 mm, based on the bone crest (S–IC buccal and S–IC
in excess of 10 cigarettes, or equivalent, their cervical diameter. Two of the im- palatal) (Fig. 4).
per day during the healing period. plants, the 3.5 and 4 mm variety, are cy- S to OC, the horizontal distance be-
lindrical (group A). The 4.5 and 5 mm tween the implant surface and the outer
implants are cylindrical in the apical por- surface of the bone crest (S–OC buccal
Treatments
tion while the cervical portion is tapered and S–OC palatal) (Fig. 4).
Before implant placement, the selected
(conical) (group B). The apical diameter is R to D constituting the vertical defect
tooth was carefully extracted with the use
3.5 mm on the 4.5 implants and 4 mm on distance from the rim of the implant to
of a periotome. In the removal of multi-
the 5 implant. the base of the defect (R–D buccal and
rooted teeth, sectioning of the tooth in a
The implants were placed in accordance R–D palatal) (Fig. 5).
mesial/distal dimension was accomplished
with the guidelines described in the Astra
with a high-speed hand-piece and an appro-
Tech Manualt ‘Surgical Procedures.’
priate burr.
After implant insertion, a gap occurred
Provided the extraction socket met the
between the implant surface and the hard
inclusion criteria, the site was allocated to
tissue walls of the extraction socket. This
either treatment group A (Test) or B (Con-
defect could be present at the buccal, me-
trol). An independent randomization sche-
sial, palatal and distal aspects of the im-
dule was generated for each center in
plant. In order to describe the size of the
blocks and designed to ensure a balanced
defect, the following landmarks were de-
distribution of treatments. In each center,
fined (Fig. 3):
the randomized treatment code was avail-
able in closed non-transparent envelopes. Surface of implant (S).
Fig. 1 presents the randomization and Rim of implant (R).
treatment allocation flow chart. Top of the bone crest (C).
Two types of implant configurations Inner border of the bone crest (IC),
were used (Fixture Microthreadt OsseoS- 1 mm apical of C.
peedt, Astra Tech AB, Mölndal, Sweden). Outer border of the bone crest (OC),
Such implants (Fig. 2) are available in four 1 mm apical of C.
Base of the defect (D).
16 | Clin. Oral Impl. Res. 21, 2010 / 13–21 c 2009 John Wiley & Sons A/S
Sanz et al Bone alterations after immediate implant installation
size of the void established by using differ- the re-entry procedure at 4 months. Six The dimensional alterations that
ent implant geometries. A void between subjects had two randomized implants, one occurred during healing are reported in
the titanium surface and the inner aspect of in each subject was excluded by tossing a Tables 2–5.
the socket will allow formation of a stable coin. Hence, a total of 93 implant sites in
coagulum, the proper maturation of which 93 subjects were included in the analysis
Dimension S–OC (Table 2)
will be followed by hard tissue formation. (45 in group A and 48 in group B).
The mean reduction of S–OC during the 16
The use of a conical/cylindrical implant The demographic and key baseline char-
weeks that followed implant installation
(Control – group B) obviously reduced the acteristics of the study subjects, including
was 1.2 and 1.0 mm (groups A and B) at
size of the void. The assumption is that a implant diameter, reason for extraction,
the buccal aspect and 0.6 and 0.4 mm in
cylindrical implant (Test – group A), by smoking during healing and thickness of
groups A and B at the palatal aspect. This
providing more space for the coagulum, the buccal bone walls, are summarized in
represents a 43% and 30% buccal and an
will have a positive effect on the preserva- Table 1. In general, the baseline character-
18% and 11% palatal reduction in groups
tion of the bone and that this in turn will istics of the two groups were similar. Me-
A and B. These differences between
result in less marked decrease of the S to chanical (primary) implant stability (lack of
the two groups were not statistically
OC dimension. With this assumption, the mobility, when the healing abutment was
significant.
sample size was calculated using the re- applied) was obtained in 97% of the cases.
sults from an earlier study (Botticelli et al. All implant sites except two healed un-
2004) that also assessed the horizontal eventfully. In one site the patient reported Dimension S–IC (horizontal gap) (Table 3)
distance from the implant surface to the pain after surgery and at one site the clin- The horizontal gap underwent marked
other surface of the bone crest at 4 months ician reported the occurrence of swelling changes during healing at both the buccal
after implant installation. They reported a and inflammation at suture removal. The and the palatal aspects of the implant.
56% reduction of this distance. The as- following complications were reported at re- Thus, on the buccal aspect, the reduction
sumption was that this reduction, when a entry: incomplete buccal bone fill (1 site), amounted to 1.6 (80%) and 1.4 mm (63%)
cylindrical implant was used (Test), would incomplete buccal bone fill and implant (groups A and B), while on the palatal
be 20% less. Assuming an intra-patient mobility (1 site) and loss of the entire buccal aspects, the change amounted to 0.9
standard deviation of the change of bone wall (1 site). Bone regeneration was (70%) and 0.4 mm (58%), respectively.
0.9 mm in both groups and 80% power, used in the first two cases and the implant The reductions in the gap size, both in
together with a foreseen dropout of 8%, was explanted in the third situation. the buccal and the palatal aspects, were
120 patients needed to be included.
Demographics and other baseline char-
acteristics were presented by means of Table 1. Baseline characteristics of the study sample
descriptive statistics. Continuous variables Treatment group
were presented by means of number of A (n ¼ 45) B (n ¼ 48) Total (n ¼ 93)
observations (N), minimum (min), med-
Sex (n and % of subjects)
ian, maximum (max), mean and standard Male 28 62% 20 42% 48 52%
deviation (SD) and discrete variables by Female 17 38% 28 58% 45 48%
frequency and percentage. Age (years)
Mean (SD) 50.4 (13.1) 51.8 (13.5) 51.1 (13.2)
Inter-group comparisons were performed
Median 51 53 52
using Student’s t-test. A two-sided P-value Range 19 –73 23–80 19–80
of P 0.05 was considered to be statisti- Smoking during healing (n and % of subjects)
cally significant. No 31 69% 31 65% 62 67%
Yes 14 31% 17 35% 31 33%
Teeth extracted (n and % of subjects)
Central incisor 5 11% 5 10% 10 11%
Results Lateral incisor 9 20% 10 21% 19 20%
Canine 3 7% 7 15% 10 11%
First and second premolars 28 62% 26 54% 54 58%
Fig. 1 presents the study population. It Main reason for extraction (n and % of subjects)
consisted of 108 subjects, 104 treated, 95 Trauma 5 11% 5 10% 10 11%
randomized and 93 subjects who remained Caries/endodontic 33 73% 30 63% 63 68%
Periodontitis 6 13% 10 21% 16 17%
in the study at re-entry (16 weeks; Fig. 1).
Other 1 2% 3 6% 4 4%
In these 93 subjects, 99 implants had been Thickness of buccal bone wall
placed: 50 in group A and 49 in group B. Mean (SD) 1 (0.5) 0.9 (0.5) 1 (0.5)
The 93 randomized subjects were distrib- Median 1 1 1
Range 0.5–2 0.5–3 0.5–3
uted as follows: 25 in Center 1, 37 in
Implant diameter (n and % of subjects)
Center 2 and 31 in Center 3. Four subjects 3.5 1 2% 0 0% 1 1%
discontinued before treatment. Nine sub- 4 44 98% 0 0% 44 47%
jects did not meet the inclusion/exclusion 4.5 0 0% 42 88% 42 45%
5 0 0% 6 12% 6 6%
criteria. Two subjects discontinued before
Table 2. Crestal bone resorption that occurred in groups A and B between surgery and 1.6 mm (58%). Differences between groups
re-entry (16 weeks) as described by changes of the dimension S–OC were not statistically significant.
S–OC A (N ¼ 45) B (N ¼ 48) P A þ B (N ¼ 93)
Buccal
At surgery 3.1 1.2 3 1.1 0.64 3 1.1 Dimension R–C (vertical crest reduction)
At 16 weeks 1.9 1.2 2 1.2 0.53 1.9 1.2 (Table 5)
Difference 1.2 0.9 1 1.1 0.26 1.1 1 The reduction of the height of the marginal
Mean % reduction 43 34 30 39 0.08 36 37 bone crest was more pronounced at the
Median % reduction 40 33 37 buccal than at the palatal aspect of the
Palatal
At surgery 2.5 0.8 2 0.9 0.0074n 2.2 0.9
extraction site (1.0 vs. 0.5 mm). There
At 16 weeks 1.9 0.8 1.6 0.8 0.08 1.8 0.8 was, however, no difference between
Difference 0.6 0.9 0.4 0.7 0.23 0.5 0.8 groups A and B regarding this outcome
Mean % crest reduction 18 37 11 35 0.34 14 36 variable.
Median % crest reduction 33 0 0
n
Statistically significant.
Buccal and palatal measurements are reported separately (mean and SD). Discussion
18 | Clin. Oral Impl. Res. 21, 2010 / 13–21 c 2009 John Wiley & Sons A/S
Sanz et al Bone alterations after immediate implant installation
Table 5. Change of the position of the marginal bone crest and amount of cresta resorption palatal) that had occurred between baseline
in groups A and B between surgery and re-entry (16 weeks) as described by changes of the and 4 months amounted to about 60–70%.
dimension R–C
R–C A (N ¼ 45) B (N ¼ 48) P A þ B (N ¼ 93)
Also, this extent of defect reduction corro-
borates the findings of Botticelli et al.
Buccal
At surgery 0.4 1.1 0.1 0.9 0.17 0.3 0.1
(2004) and illustrates that only minor mar-
At 16 weeks 0.6 1.7 0.8 2.2 0.53 0.7 1.9 ginal defects may remain 4 months after
Difference 1 1.7 1 2.2 0.96 1 2 Type 1 treatment.
Palatal The primary objective of the present trial
At surgery 0.2 1.6 0 1.3 0.65 0.1 1.4
At 16 weeks 0.3 1.1 0.4 1.3 0.67 0.4 1.2 was to compare the ridge and gap alterations
Difference 0.5 1.6 0.5 1.4 0.91 0.5 1.5 that occurred following Type 1 placement
of implants with different configurations
Buccal and palatal measurements are reported separately (mean and SD).
(cylindrical vs. conical/cylindrical), i.e. im-
plants that, in the marginal portion, occu-
tooth loss. This confirms findings from a observations of studies in dogs (Araújo pied different volumes of the extraction
clinical study (Botticelli et al. 2004). It was et al. 2005). In hemi-sectioned mandibular socket. In this context, it must be observed,
observed that 4 months after the removal of premolars, distal roots were extracted. In however, that the vast majority of the
single teeth (maxillary and mandibular one quadrant, implants were placed into implants used had a marginal diameter of
canines and premolars) and immediate the post-extraction sockets (implant sites), either 4 mm (group A) or 4.5 mm (group B),
implant placement, the buccal–lingual di- while in the contralateral site, the sockets i.e. a difference between the groups of only
mension of the marginal portion of the were left without additional therapy (coa- 0.25 mm in the buccal, palatal, mesial and
edentulous sites was substantially reduced gulum sites). In biopsies sampled after 3 distal directions.
(about 2.8 mm or 40%). In the current months of healing, it was observed that the Two variables (S–OC; buccal, palatal
study, the corresponding ridge reduction buccal–lingual diminution that had oc- and R–C; buccal, palatal) were used to
at 4 months was somewhat smaller curred in the alveolar ridge at the implant study dimensional changes of the ridge
(1.6 mm or about 25%) than that reported and coagulum sites was similar. In this that occurred in the two treatment groups.
by Botticelli et al. (2004). The reason for context, it should be observed that the It was observed that during the 4 months of
this discrepancy in treatment outcome is buccal–lingual reduction occurred only in healing, there was a marked horizontal
presently not understood, but may be re- the marginal third of the extraction site contraction of the marginal ridge in both
lated to the larger number of patients and (Araújo et al. 2008, Araújo & Lindhe groups. In group A, S–OC (buccal þ palatal)
sites treated as well as the larger number of 2009), i.e. in a location where the volume was reduced by1.8 mm, with a similar
clinicians who were involved in the present of the extracted root is large and the buccal/ change in group B (1.4 mm). Also, the
clinical trial. lingual bone walls are comparatively thin. ‘vertical’ reduction (R–C) of the buccal
In the current study, the hard tissue Following Type 1 implant placement, a and palatal walls of the socket was similar
resorption that occurred during healing marginal defect often occurs between the in the two treatment groups and amounted
following tooth extraction and Type 1 im- walls of the socket and the titanium device to about 1 mm at the buccal and 0.5 mm at
plant placement was twice as large at the (e.g. Lang et al. 2007; Hämmerle et al. the palatal aspects. In other words, the
buccal as at the palatal aspect of the ridge 1998; Wilson et al. (1998); Botticelli et al. reduction of the ridge that occurred follow-
(36% vs. 14%). This is in agreement with 2004). This defect is rapidly filled with a ing tooth extraction in the current study
the findings of Botticelli et al. (2004), who coagulum that is subsequently replaced was apparently independent of the geome-
observed that the corresponding buccal with bone (Araújo et al. 2006). In the try of the implants used to substitute for
hard tissue dimension amounted to current study, it was observed that the the tooth.
1.9 0.9 mm while the change at the horizontal component of the buccal gap, During installation, implants were dur-
lingual/palatal aspect was considerably which, was 2.1 1.1 mm at baseline, had ing installation obviously placed in the
smaller (0.9 0.6 mm). The data of the reduced to 0.6 0.7 mm (reduction 71%) palatal part of the socket. This is evidenced
present study also corroborate findings by at the 4-month re-entry examination inter- by the fact that S–C buccal at the aspect
Pietrokovski & Massler (1967), who car- val. The corresponding percentage reduc- was 2.1 mm (group A) and 2.2 mm (group
ried out measurements on casts of 149 tion of the palatal gap was similar and B), while the corresponding dimension at
dentate jaws in which one tooth was miss- amounted to 66%. This change of the the palatal aspect (S–C; palatal) was mark-
ing on one side while the contra-lateral dimension of the marginal gap confirms edly smaller (1.4 mm group A and 0.8 mm
tooth was present. Their measurements, the data presented by Botticelli et al. group B). This also means that the buccal
which included both soft and hard tissues, (2004). They reported that the gap, which void at baseline was larger than the void at
indicated that tissue resorption following was on average 2.0 mm (buccal) and the palatal aspect and that consequently
tooth loss in the maxillary incisor, canine 1.5 mm (lingual) wide at baseline, had the space that potentially could be filled
and premolar region was much more pro- been reduced to 0.4 mm for both aspects with hard tissue was larger buccally than
nounced in the buccal than in the palatal at the re-entry assessments after 4 months. palatally. Hence, it is not surprising to find
compartment of the alveolar ridge. The In the present study, the degree of ver- that the amount of hard tissue fill was
results of the present study also support tical bone fill (change R–D, buccal þ substantially larger at the buccal (1.6 and
1.4 mm) than at the palatal aspect (0.9 and tissue changes that occurred at the mesial ridge alterations following tooth extraction
0.4 mm). The residual (at 4 months) hor- and distal septa between the extraction site on models (hard and soft tissues com-
izontal gap at the palatal aspect was similar and adjacent teeth following single tooth bined), found that the contraction – in the
(0.4 vs. 0.5 mm) in the two groups while at extraction and concluded that only minor marginal 1/3rd of the ridge which, at the 3-
the buccal aspect of the extraction site the alterations took place at such interproximal month interval, was 30% had increased to
residual void was twice as large in group B locations during a 12-month period of heal- 50% after 12 months. In other words,
as in group A (0.8 vs. 0.4 mm). This ing. The present findings are also in agree- during the first 3 months, 3.6 mm of the
difference between the conical and the ment with the results obtained by Botticelli horizontal dimension was lost while during
cylindrical implants is presently not under- et al. (2004), who demonstrated that less the subsequent 9 months an additional
stood. change had occurred at mesial and distal 2.4 mm disappeared.
In the current study, single maxillary aspects of the socket than at buccal and
teeth were removed while the adjacent lingual portions 4 months following single
teeth were retained during the healing tooth extraction and Type 1 implant place- Acknowledgements: The study has
period. It was observed that whereas the ment. been supported by a research grant
height of the buccal and lingual bone crests The hard tissue changes that occurred in from Astra Tech AB. The authors wish
of the extraction site was reduced, the the current clinical trial during the first 4 to acknowledge the diligent support
mesial and distal socket walls remained months of healing were quite substantial regarding study monitoring and data
unchanged. This finding is in agreement but additional change may in fact occur management provided by Ann-Sofie
with data from the study by Schropp et al. during later phases of tissue remodeling. Andersson and Frederik Ceder at the
(2003) referred to above. They examined Thus, Schropp et al. (2003), who studied Astra Tech.
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