JOMI on CD-ROM (1997 © Quintessence Pub. Co.), 1997 Vol. 12, No.

1 (17 - 24): Success and Failure Rates of Osseointegrated Implants in Functio

Success and Failure Rates of Osseointegrated

Implants in Function in Regenerated Bone for 6 to 51
Months: A Preliminary Report
Paul A. Fugazzotto, DDS

Six hundred twenty-six titanium plasma-sprayed cylindrical implants that had been functioning in
regenerated bone for a period of up to 51 months were evaluated according to Albrektsson’s
criteria. These implants had been placed either with concomitant guided bone regeneration
procedures or in bony ridges that had previously been augmented. According to Albrektsson’s
criteria, absolute success rates of 97.6% overall, 98.8% in the maxilla, and 98.2% in the mandible
were recorded, as were cumulative success rates of 94.9% in the maxilla and 91.9% in the
mandible. The overall cumulative success rate was 93.8%. One patient, who underwent protracted
chemotherapy 14 months after implant function began, accounted for 33% (3 of 9) of the total
implant loss in the study. If this patient is excluded from the study, the cumulative success rates are
94.9% (maxilla), 96.7% (mandible), and 95.8% (overall). These findings support the theory that
regenerated bone will achieve osseointegration with titanium plasma-sprayed cylindrical implants,
and that this osseointegration can be maintained under function over time.
(INT J ORAL MAXILLOFAC IMPLANTS 1997;12:17–24)
Key words: function, guided bone regeneration, implant, IMZ

G uided bone regeneration (GBR) procedures have evolved from the immediate placement of an
implant into an extraction socket to a variety of techniques aimed at regenerating lost hard tissues in
different clinical situations.1-4 These procedures have greatly expanded the applicability of implant
therapy through the preservation of existing bone at the time of tooth extraction, the regeneration of bone
over implant dehiscences and/or fenestrations, or the regeneration of lost alveolar ridge prior to implant
placement.5-9
The short-term success of these procedures is well documented in a number of case report and animal
and human studies.10-13 However, the long-term efficacy of such techniques has not yet been
established. Questions remain concerning the rate of maturation of the regenerated hard tissues, the
response of such tissues to applied forces, and the optimal time frame in which to functionally load such
tissues.12,14,15 Studies indicate continued remodeling of the regenerated hard tissues for up to 1 year
postoperatively, with as much as 1.7 mm of bone loss around the implants after 1 year in function. 16,17
“Progressive loading” theoretically allows the regenerated bone to better adapt to applied loads, thus
increasing long-term success. These questions have not been answered definitively.
A question of potentially even greater importance is that of the stability of implants in function in
regenerated bone over time. There is a paucity of publications documenting the long-term clinical
success or failure of such procedures. The purpose of the present study was to present preliminary
statistics related to implants in function in regenerated bone from 6 to 51 months.
Materials and Methods

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JOMI on CD-ROM (1997 © Quintessence Pub. Co.), 1997 Vol. 12, No. 1 (17 - 24): Success and Failure Rates of Osseointegrated Implants in Functio

Following a thorough review of medical histories, patients were deemed unsuitable to receive implant
therapy based on the following criteria: (1) the presence of uncontrolled diabetes, immune diseases, or
other contraindicating systemic conditions; (2) radiation therapy to the head and neck region in the
12-month period prior to proposed therapy; (3) chemotherapy in the 12-month period prior to proposed
therapy; (4) uncontrolled periodontal disease, or an unwillingness to undergo needed periodontal therapy,
around remaining teeth; (5) severe psychologic problems; and (6) an unwillingness to commit to a
long-term, posttherapy maintenance program.
A complete examination of oral hard and soft tissues was carried out for each patient, and an overall
dental treatment plan was formulated in conjunction with the treating restorative dentists. Panoramic
radiographs were taken of all patients, as were formatted computerized axial tomography scans when
they were deemed clinically necessary. Diagnostic casts, waxups, and surgical guides were also utilized
as needed.
Three hundred thirty-one patients were treated. Of these patients, 185 were female (55.9%) and 146
were male (44.1%). Patient age ranged from 17 to 82 years. All surgical therapy and preoperative and
postoperative measurements were recorded by the author. All radiographs were taken by one of two
dental assistants and were exposed utilizing a Rinn kit (Rinn, Elgin, IL) to standardize the radiographs as
much as possible in a clinical practice setting.The following materials were utilized when deemed
clinically necessary:
1. IMZ titanium plasma-sprayed (TPS) implants (Interpore International, Irvine, CA) of 3.3, 4.0, or 4.25
mm in diameter and in various lengths
2. Titanium plasma-sprayed hex-head cylindrical implants (Interpore International) of 4.0 mm diameter
and in various lengths, for the replacement of missing single teeth
3. Expanded polytetrafluoroethylene (e-PTFE) membranes (WL Gore, Flagstaff, AZ) of various
configurations
4. Demineralized freeze-dried bone allografts (DFDBA) (Musculoskeletal Foundation, Holmoel, NJ)
with a particle size of 500 to 800 µm
5. Resorbable tricalcium phosphate (TCP) (Miter, Warsaw, IN)
Following full-thickness buccal and lingual and/or palatal flap reflection, therapy proceeded along
one of the following courses (Table 1):
1. Tooth extraction, debridement of the extraction socket, and immediate implant placement. The
residual socket was filled with DFDBA, and the area was covered with an e-PTFE membrane.
2. Implant placement with a resultant buccal fenestration. The fenestration was covered with a mixture
of equal parts DFDBA and TCP. An e-PTFE membrane was then placed over the fenestrated area.
Efforts were made to have the membrane overlay 2 to 3 mm of bone around the perimeter of the
fenestration. Fenestrations ranged from less than 2 mm to more than 12 mm in length (Table 2). A
fenestration denoted as “beyond apex” represented a situation where only the most coronal 2 to 3 mm
of the implant were completely in bone, and the remainder of the implant body, including the apex,
was devoid of a buccal plate of bone. (For clinical examples, see Fugazzotto et al.18)
3. Implant placement with a resultant buccal dehiscence. The dehiscence was covered with the
aforementioned mixture of DFDBA and TCP, and an e-PTFE membrane. The membrane overlay 2 to

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3 mm of bone around the perimeter of the dehiscence, covered the head of the implant, and overlay
the palatal/lingual bone by 3 to 4 mm. The extent of the treated dehiscence ranged from less than 2
mm to 14 mm (Table 3). As a result, four dehisced implants that were treated demonstrated
dehiscence of the buccal aspect of the implant to within 1 mm of the implant apex.
4. Buccal ridge augmentation of an area deemed to be of insufficient buccolingual/palatal dimension to
stabilize an implant in an acceptable position for subsequent restoration (ie, the residual ridge was
resorbed to such an extent that, regardless of the size of the fenestration/dehiscence that would be
considered permissible, the implant could not be primarily fixed in a restorable position). The same
mixture of DFDBA and TCP was placed. If deemed necessary, threaded stainless steel support screws
(Implant Innovations) were first positioned in the residual ridge to support the e-PTFE membrane,
which was then placed. The e-PTFE membrane extended 4 to 5 mm beyond the augmented area
buccally and 2 to 3 mm over the residual crest of the ridge lingually/palatally.
5. Coronal ridge augmentation in a residual ridge deemed to be of sufficient dimension buccolingually,
but inadequate apico-occlusally to accept implants of an adequate length to support the planned
prosthesis long term. The situation was treated in the same manner as a buccal augmentation, except
that the support screws were placed on the crest of the residual ridge. The support screws protruded
from the crest of two of the ridges for 3 mm, from the crest of six of the ridges for 4 mm, and from
the crest of one of the ridges for 5 mm.
All flaps were sutured with Gore-Tex sutures (WL Gore). Every effort was made to achieve passive
primary closure, including the utilization of a number of flap design modifications.19,20 This type of
closure was achieved in 267 of 331 patients.
Postoperative management included Peridex rinses twice a day for 21 days, 500 mg of amoxicillin
four times a day for 10 days (400 mg of enteric-coated erythromycin three times a day for 10 days was
given to penicillin-sensitive patients), 600 mg of ibuprofen four times a day for 5 days unless medically
contraindicated, and pain medication (Tylenol with codeine III [McNeil Pharmaceutical, Spring House,
PA] or Percocet [Du Pont, Wilmington, DE]) as needed for pain. Patients were not allowed to use any
removable prostheses until the suture removal visit 10 to 12 days after surgery. At that time, removable
prostheses were adjusted, relined, and placed for esthetic purposes only. Patients were not allowed to
function with these restorations for 6 weeks postoperatively. Ridge augmentation patients were never
allowed to use removable prostheses over operated sites until regeneration had been deemed complete.
Peridex rinses were continued for the total course of membrane retention if membrane exposure
occurred. Exposed membranes were only removed before 12 weeks if persistent clinical signs of
infection were noted. Of the 64 membranes that were not primarily covered at the time of surgery, 34
were removed at 4 to 6 weeks; 18 were removed at 6 to 8 weeks; and 12 were removed after 12 weeks.
Six other membranes became partially uncovered at 8 to 10 weeks postoperatively. All membranes
except those noted above were removed at the time of implant uncovering and/or placement, 6 to 9
months postoperatively.
Table 1 shows the distribution of implant placement by treatment indication. Of the 626 implants
placed, 114 were TPS hex-head implants replacing missing single teeth, and the rest were conventional
IMZ TPS cylindrical implants. Fenestration and dehiscence dimensions are documented in Tables 2 and
3.
At the time of implant uncovering, measurements were made from the top of the implant body (not
the top of the hex when hex-head implants were placed) to the crest of the residual bone at the

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midbuccal, midlingual, midmesial, and middistal aspects of the implant. Immediately following
restoration of the implants, radiographs were taken and clinical probing depths were recorded to the base
of the sulcus and the bone crest (utilizing local anesthetic as necessary) at the midbuccal, midlingual,
midmesial, and middistal aspects of the implants.
All patients were seen at least every 6 months posttherapy. At that time, all prostheses were removed,
the individual implants were examined for mobility, and clinical parameters (Gingival Index, the
presence of bleeding upon probing, and probing depth to the base of the sulcus on the aforementioned
aspects of the implants) were recorded. Radiographs were taken at yearly intervals and were compared to
those taken at the time of implant restoration under 2× magnification. In preparation for this study,
probing depth to the bone crest was measured (again with local anesthetic as necessary) on the
midbuccal, midlingual, midmesial, and middistal aspects of the implants in all patients. These
measurements were more representative of the stability of the regenerated bone over time than were
radiographic examinations, because the majority of the treated defects were on the buccal aspects of the
implants and thus could not be well assessed radiographically.
Implants were deemed successful if they met the following criteria:
1. The implant was immobile.
2. There was an absence of pain and/or suppuration.
3. There was no evidence of a peri-implant radiolucency.
4. Vertical bone loss was less than 1.5 mm in the first year in function, and less than 0.2 mm annually in
subsequent years in function.
Results
A total of 626 implants were placed in 331 patients. Of these implants, two maxillary single-tooth
replacements were lost, one after 5 months of function (in the first molar position) and one after 7 months
of function (in the position of the central incisor). Five mandibular implants were lost (Tables 4 to 7).
Three had supported a fixed prosthesis in a buccally augmented ridge and were lost after 14 months of
function. The patient with this prosthesis had begun chemotherapy 7 months after the implants had been
in function asymptomatically. The chemotherapy was still continuing at the time of implant loss. Because
these three implants supported a four-unit fixed prosthesis, their loss resulted in failure of the prosthesis.
Two implants that had supported a three-unit fixed prosthesis in a buccally augmented mandibular
posterior ridge area were lost after 17 months of function. Two additional maxillary implants (one
supporting a first premolar and the other supporting a first molar), while immobile and still functioning
asymptomatically, were classified as failures because of bone loss exceeding the established criteria of
less than 0.2 mm of bone loss annually. Therefore, although only 7 implants were actually lost during the
course of the study, there was a total of 9 criteria failures of 626 implants, yielding an absolute success
rate of 98.6%. After 51 months in function, the cumulative success rates of TPS implants placed in
regenerated bone were 94.9% for the maxilla and 91.9% for the mandible, yielding an overall cumulative
success rate of 93.8% (Table 8). However, if the one patient who subsequently underwent chemotherapy
is excluded from the statistics, the absolute success rates become 98.8% (maxilla), 99.3% (mandible),
and 99.5% (overall). The cumulative success rates, with the exclusion of the patient who underwent
chemotherapy, become 94.9% (maxilla), 96.7% (mandible), and 95.8% (overall).
Discussion

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Although the use of GBR procedures has extended the feasibility of implant placement to sites previously
viewed as untenable, few studies have examined the success and failure of implants placed in regenerated
bone, in function.5-7,12 High success rates for the initial stage of bone regeneration around implants
have been reported.7,11,13,18 However, questions abound as to when and how to optimally place such
implants. The present study was undertaken to evaluate the function of 626 consecutively placed titanium
plasma-sprayed implants, either with simultaneous GBR procedures, or after lost alveolar ridge structures
had been regenerated. Often extensive GBR procedures were carried out during the course of therapy
(see Tables 2 and 3). A large number of the implants eventually placed into function either could not
have been placed or could not have been placed in a restorable position without the use of GBR
procedures.
The statistics presented demonstrated that TPS cylindrical implants successfully functioned in
regenerated bone over the course of this preliminary study (51 months). Of 626 implants placed and
restored, 619 are immobile and functioning well (98.9%), and 617 (98.6%) are classified as successful
when judged by the Albrektsson criteria, even when the implant loss of the patient who underwent
chemotherapy is included. This is in spite of the fact that many of the implants were placed in the earlier
stages of the development of the clinical application of GBR procedures, before many of the techniques
and much of the armamentarium that exists today was readily available. The advent of more sophisticated
flap designs to help ensure the achievement of passive primary closure,19,20 titanium-reinforced
membranes (WL Gore) to maintain and protect both the created space and the maturing blood clot, and
membrane fixation tacks (Friatec, Stuttgart, Germany) have greatly improved the clinical management of
regenerative procedures.
Examination of the individual failures is, to some degree, potentially informative. The lost implants
may be classified as follows:
• One implant (4.0 mm in diameter and 8.0 mm in length) placed into an immediate extraction socket.
This implant supported an individual maxillary molar.
• One implant (4.0 mm in diameter and 8.0 mm in length) placed into an immediate extraction socket.
This implant supported an individual maxillary molar. While still immobile, the implant suffered a
loss of more than 3 mm of osseous support during the course of the study.
• One implant (4.0 mm in diameter and 11.0 mm in length) in the maxillary central incisor position,
with a treated buccal dehiscence, which was restored with a single crown.
• One implant (4.0 mm in diameter and 13.0 mm in length) in the maxillary first premolar position,
with a treated buccal dehiscence, which was restored with a single crown. While still immobile, this
implant demonstrated loss of more than 4 mm of osseous support during the course of the study.
• Two implants (4.0 mm in diameter and 11.0 mm in length) that had been placed in a buccally
augmented ridge in the positions of the mandibular first premolar and the mandibular first molar
(mesial root). These implants supported a three-unit fixed splint.
• Three implants (3.3 mm in diameter and 10.0 mm in length) placed in a buccally augmented ridge in
the positions of the mandibular first premolar, the mandibular first molar (mesial root), and the
mandibular second molar (mesial root). These implants supported a four-unit fixed splint. The
implants were functioning well with no evidence of osseous loss around them until the patient began
chemotherapy 7 months after the implants were restored. Within 7 months after the initiation of

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chemotherapy, the implants were lost.

It is difficult to draw definite conclusions as to the causes of the failures because the number of
failures is relatively small. At best, the data may afford insights into potential pitfalls with therapy, rather
than offer absolute criteria for exclusion of a given approach. None of the failed or failing implants
demonstrated a significant increase in gingival inflammation, Plaque Index, etc. The exact cause of
failure of the three implants in one augmented ridge after 14 months of successful function is unknown,
although the author suspects that the initiation of chemotherapy played a significant role in this failure.
Of the six remaining failures, four were restored with single porcelain-fused-to-gold crowns. Of
these, two were fairly rapidly occurring absolute failures, raising the possibility that the implants had not
adequately osseointegrated. Another was a failing 8.0-mm-long implant that supported a
porcelain-fused-to-gold crown on a maxillary first molar. Although there were no overt signs of clinical
inflammation, loss of osseous support occurred at an unacceptable rate. This would seem to indicate a
potential occlusal overload problem. The clinical scenario surrounding this implant could certainly be
compatible with such a diagnosis. The implant is short; it is placed in an area that often exhibits poorer
quality bone; the restoration is one with an occlusal table much larger than the diameter of the supporting
implant; and the restored tooth bears significant occlusal forces in normal function.
The fourth single-tooth replacement that failed was the 4.0-mm-wide, 13.0-mm-long implant in the
position of a maxillary first premolar. The patient with this implant has been diagnosed as exhibiting
parafunctional habits, and he wears a processed acrylic resin nightguard. No prosthesis is worn during
the day. Although a relationship between implant loss and parafunctional habit cannot be definitively
demonstrated, no other causative agents have been noted.
Significant occlusal loads may have also played a role in the loss of the two implants supporting a
three-unit fixed splint in the posterior mandible. These implants (both 4.0 mm in diameter and 11 mm in
length) were placed in the positions of the distal root of the mandibular second molar and the second
premolar to support a three-unit ceramometal restoration opposing a fixed splint on natural teeth. If this
load exceeded the threshold of the TPS-to-bone bond (even with the use of a resilient element interposed
between the implants and prosthesis), disintegration would likely occur over time. This would help to
explain their loss after 17 months in function because there was no evidence of an increase in Plaque
Index, or other signs of a lack of patient compliance.
It should be noted that in a theoretical attempt to control force transmission to the bone-implant
interface under function, all implants, with the exception of the single-tooth replacements, were restored
with a resilient element, as mandated by the IMZ protocol. Single-tooth replacements exhibited the
highest degree of failure (4 of 114 single-tooth replacements, yielding a failure rate of 3.5%, compared to
5 of 512 that were restored with intramobile elements yielding a failure rate of 0.97%). Although the
author is by no means stating that the use of an intramobile element is essential for implant success in
regenerated bone, the use of such a component may help to protect the bone when implants of inadequate
length or too few a number have been placed.
Summary
The stability of regenerated bone around implants in function was examined for up to 51 months. The
extent of regenerated bone varied from simple rebuilding of lost alveolus over a fenestrated implant, to
extensive ridge augmentation procedures. All regenerative procedures were carried out via a combination
of particulate material and Gore-Tex membranes. This regenerated bone was demonstrated to be capable
of supporting implants and responding to functional forces in a healthy, predictable manner.

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Paul A. Fugazzotto

Private Practice,
Milton,
Massachusetts.

TABLES

Table 1

Tables 7
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Table 2

Table 3

Tables 8
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Table 4

Table 5

Tables 9
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Table 6

Table 7

Tables 10
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Table 8

Success and Failure Rates of Osseointegrated Implants in Function in Regener

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