IMPLANT DENTISTRY / VOLUME 23, NUMBER 3 2014
Evaluation of a Dense
Polytetrafluoroethylene Membrane to
Increase Keratinized Tissue: A
Randomized Controlled Clinical Trial
Eliane Porto Barboza, DScD,* Bianca Stutz, MScD,† Denize Mandarino, MScD,‡ Diogo Moreira Rodrigues, MScD,§
and Vinícius Farias Ferreira, MScDk
lveolar bone resorption is
A a common finding after tooth
extraction.1,2 This can make it
difficult or even impossible to place
dental implants. Therefore, post-
extraction alveolar ridge preservation
is essential to ensure maintenance of
ideal vertical and horizontal ridge di-
mensions and contours required for
ideal 3-dimensional implant place-
ment.3 Preservation of soft tissues after
tooth extraction is important as well.
The presence of an adequate zone of
keratinized tissue has been associated
with a more stable implant-mucosal
barrier.4–7 In addition, a recent study
showed that patients presenting thin
periodontal phenotype had 4.5 times
greater probability to present periim-
plant disease.8
The techniques of guided bone
regeneration have been successfully
applied in the treatment of bone defects
and for increasing the width and height
*Associate Professor, Department of Periodontology,
Fluminense Federal University, Rio de Janeiro, Brazil.
†Private Practice, Rio de Janeiro, Brazil.
‡Adjunct Professor, Department of Periodontology, Fluminense
Federal University, Rio de Janeiro, Brazil.
§Graduate Student, Department of Periodontology, Fluminense
Federal University, Rio de Janeiro, Brazil.
kGraduate Student, Department of Periodontology, State
University of Rio de Janeiro, Rio de Janeiro, Brazil.
Reprint requests and correspondence to: Eliane Porto
Barboza, DScD, Associate Professor, Fluminense
Federal University, Department of Periodontology, Rua
Mario Braga 29, Valonguinho, Niterói, Rio de Janeiro
24040-110, Brazil, Phone/Fax: 55 21 2220-6940,
E-mail: barbozae@uol.com.br
ISSN 1056-6163/14/02303-289
Implant Dentistry
Volume 23  Number 3
Copyright © 2014 by Lippincott Williams & Wilkins
DOI: 10.1097/ID.0000000000000060
289
Background: The presence of an
adequate zone of keratinized tissue has
been associated with implant health.
This study evaluated the increasing
of the zone of keratinized tissue
using dense polytetrafluoroethylene
(d-PTFE) membranes over extraction
sites, without primary closure.
Materials and Methods: Fifteen
sites received d-PTFE membranes.
The control sites received no mem-
branes. All cases were sutured with
no attempt to achieve primary clo-
sure. Before surgery, initial meas-
urements of buccal and lingual
keratinized tissue were taken from
the mucogingival line (MGL) to the
most coronal gingival margins.
Final measurements were taken from
of the alveolar ridge in many animal and
human studies.9–17 The membrane mate-
rial with the longest history of use for
this purpose is expanded polytetra-
fluoroethylene (e-PTFE), a nonresorb-
able synthetic polymer. Despite the
high predictability of bone regeneration
using e-PTFE barriers, the main disad-
vantage of this material is that membrane
exposure can result in bacterial contam-
ination, inflammation, and subsequent
infection, leading to early removal of
the membrane. Several investigators
have reported a reduced amount of bone
fill in these situations.18–20
the buccal MGL to the lingual MGL,
60 and 90 days after extractions.
Results: In the test group,
a mean increase in the zone of
keratinized tissue of 7.06 6 2.63
mm and 6.6 6 2.84 mm was
observed in 60 and 90 days, respec-
tively. In the control group, a mean
increase of 2.46 6 1.59 mm and
1.40 6 1.40 mm was observed in
60 and 90 days, respectively.
Conclusion: Nonexpanded d-
PTFE membranes can predictably
be used to increase the zone of
keratinized tissue in preparation to
implant placement. (Implant Dent
2014;23:289–294)
Key Words: biomaterial, keratinized
tissue, guided bone regeneration
An alternative to an e-PTFE or
resorbable membrane is a dense polyte-
trafluoroethylene membrane (d-PTFE).
In contrast to porous expanded PTFE,
d-PTFE has been shown to withstand
exposure in the mouth with a low risk of
infection.21,22 Consequently, large hori-
zontal flaps and vertical releasing inci-
sions are not necessary to completely
cover the membrane in certain clinical
situations, such as to provide coverage
for particulate grafting materials in rela-
tively intact extraction sites. This is an
important advantage of d-PTFE mem-
brane because it may be esthetically
290 EVALUATION OF A DENSE PTFE MEMBRANE
advantageous to intentionally leave
PTFE exposed to preserve and poten-
tially improve soft tissue architecture.22
The purpose of this study was to
clinically evaluate the increase of the
zone of keratinized tissue, using
d-PTFE membranes without primary
closure over mandibular posterior
extraction sockets.
MATERIAL AND METHODS
This study was performed in com-
pliance with the principles outlined in
the Declaration of Helsinki concerning
experimentation involving human sub-
jects. Quality assessment was carried
out based on the Randomized Con-
trolled Trial (RCT) checklist of the
CONSORT statements.23 All proce-
dures and materials in this study were
approved through the relevant indepen-
dent committee on the Ethics of Human
Research of Fluminense Federal Uni-
versity (CEP/HUAP #186/05), and the
volunteer subjects were informed about
the study protocol and required to sign
a consent form. Thirty patients partici-
pated in this RCT, which took place in
the Dental Clinical Research Center at
Fluminense Federal University, Rio de
Janeiro, Brazil. All patients were in
good general health, aged 20 to 60
years, presenting 30 mandibular poste-
rior teeth with indications for extraction
because of root fracture, perforation or
periapical lesions, and presenting adja-
cent teeth.
Exclusion criteria included debili-
tating or systemic disease, smokers,
allergies, chronic medication, which
affect bone metabolism, poor oral
hygiene, or any contraindications for
surgical treatment.
Patients underwent periodontal
therapy (when necessary) and were
given oral hygiene instruction to reduce
the microbial flora and provide an
environment conductive to healing.
Surgical Procedures
The volunteer subjects were ran-
domly assigned to the tests or control
groups using an envelope system dis-
tribution provided by the principal
investigator. In the test group, 15
extraction sites received d-PTFE mem-
branes. The control group included 15
extraction sites that received no
TO INCREASE KERATINIZED TISSUE  BARBOZA ET AL
membranes. The surgical protocol and
measurements were the same for both
test and control groups. The same
surgeon performed all surgeries.
Before tooth extractions, initial
measurements (t0) were taken in both
test and control groups. A customized
acrylic template containing vertical
grooves, at the mid-facial and mid-lin-
gual, was used as a fixed reference guide
to allow reproducible measurements Fig. 1. Acrylic template for measurements
(Fig. 1). From these reference points, standardization.
the measurements of the buccal and the
lingual keratinized tissues were taken
from the mucogingival line (MGL) to
the most coronal gingival margins,
using a periodontal probe (UNC-15;
Hu-Friedy Mfg. Inc., Chicago, IL). To
evaluate the reliability of this measure-
ment method, before this study, the oper-
ator recorded the distance from the MGL
to the most coronal gingival margin on 2
different days. These measurements
were compared, and the agreement was Fig. 2. Test group. Membrane in place. Note
significant at the level of 0.01. that no attempt was made to achieve primary
Tooth extractions were performed closure.
under local anesthesia. An intrasulcular
Fig. 3. A, Membrane aspect right before its removal; B, newly formed tissue immediately after
membrane removal.
incision was made extending to the
adjacent teeth. No vertical releasing in-
cisions were performed to preserve the
MGL in its original position. If necessary,
teeth were sectioned within the socket to
preserve the bone walls. After the extrac-
tions, all sockets were carefully curetted
to remove any residual soft tissues. The
randomization envelope was opened,
and the assigned treatment test (d-PTFE
Fig. 4. Test group 60 days after tooth
membranedCytoplast Regentex TXT- extraction. Note the preservation of the MGL
200; Osteogenics Biomedical Inc., Lub- on its original position and the increase in the
bock, TX) or control (no membrane) was zone of keratinized tissue.
revealed to the surgeon.
 IMPLANT DENTISTRY / VOLUME 23, NUMBER 3 2014 291

The membranes were trimmed and
placed over the extraction sockets. In
these cases, mini full-thickness flaps
(around 3 mm) were performed on
buccal and lingual aspects of the teeth
to allow membrane placement. In all
cases, membranes were intentionally
left exposed. Both test and control
groups were sutured with no attempt
to achieve primary closure (Fig. 2).
MEDICATION AND
POSTOPERATIVE CARE
Patients were prescribed systemic
antibiotic (amoxicillin 500 mg 3 times
a day for 7 days after surgery) and
analgesics (acetaminophen 750 mgd6/6
hours for 3 days). All patients rinsed
twice daily with 0.12% chlorhexidine
digluconate solution (Periogard; Col-
gate-Palmolive, São Paulo, Brazil)
until membrane removal. Sutures were
removed 7 days after surgery.
In the test group, membranes were
removed 28 days after surgery. No
surgical procedures were necessary
during membrane removal. The epithe-
lial tissue formed between flap and
membrane was removed using peri-
odontal curettes to make it possible to
expose the connective tissue. The
neoformed tissue was not disturbed
(Fig. 3, A and B).
Sixty and ninety days after tooth
extractions, patients were re-evaluated
and new measurements were taken
(t1 and t2, respectively). Aspects such
as color, texture, and presence or
absence of signs of inflammation or
infection were also observed. In the
test and control groups, new measure-
ments were performed similarly, with
the aid of a very thin milimetric ruler
placed from the buccal MGL to the lin-
gual MGL, using the reference point.
The increase in the zone of keratinized
tissue was evaluated by comparison of
initial and final measurements (t1 − t0
for 60 days and t2 − t0 for 90 days). A
statistical analysis was performed with
the Mann-Whitney test. A 5% level of
significance and a 95% confidence
interval were set for all statistical
procedures. The statistical software
SPSS for Windows (SPSS 13.0;
SPSS Inc., Chicago, IL) was used
throughout.
RESULTS
None of the patients involved in this
study reported any unusual pain or
discomfort, abscess, swelling, or allergic
reactions during the course of treatment.
Although plaque accumulation was
observed on surfaces of the intentionally
exposed membranes, no signs of tissue
inflammation or exudate were detected.
Soft tissue presenting macroscopic char-
acteristics of normal keratinized gingiva,
such as color, consistency, and texture
was observed in all cases. Clinically, the
original MGL position seemed to be
preserved (Fig. 4).
The results of this study are shown in
Table 1 (test group) and Table 2 (control
group). A mean increase of 7.06 6
2.63 mm and 2.46 6 1.59 mm was
observed after 60 days (t1) in the test
and control groups, respectively (Tables
1 and 2). After 90 days (t2), a mean
increase of 6.6 6 2.84 mm and 1.40 6
1.40 mm was observed in the test and
control groups, respectively. A decrease
was observed in these measurements
in both groups between 60 and 90 days
(t2 − t1). The test and control group
showed a mean decrease of 0.46 6
1.12 mm and the control group 1.06 6
0.59 mm, respectively (Tables 1 and 2).
Tissue measurements did not present
normal distribution allowing nonpara-
metric test (Shapiro-Wilk P . 0.05).
The Mann-Whitney test showed
statistically significant differences

Table 1. Test Group Description and Measurements

t0 t1 t2 t1 − t0 t2 − t0 t2 − t1
Patient Gender Age Tooth (mm) (mm) (mm) (mm) (mm) (mm)
1 F 45 30 8 14 12 6 4 −2
2 M 27 29 15 19 19 4 4 0
3 F 60 30 10 16 16 6 6 0
4 F 40 19 5 7 7 2 2 0
5 F 35 19 8 14 14 6 6 0
6 F 52 18 8 14 14 6 6 0
7 M 48 30 10 17 13 7 3 −4
8 M 48 19 10 20 19 10 9 −1
9 F 48 30 10 19 19 9 9 0
10 F 47 29 8 14 14 6 6 0
11 F 28 28 13 22 22 9 9 0
12 M 22 30 19 32 32 13 13 0
13 M 35 31 17 26 26 9 9 0
14 M 28 18 13 20 20 7 7 0
15 F 45 20 13 19 19 6 6 0
Mean 40.53 11.13 18.2 17.73 7.06 6.6 −0.46
Minimum 22 5 7 7 2 2 −4
Maximum 60 19 32 32 13 13 0
SD 10.89 3.81 5.83 6.07 2.63 2.84 1.12
t0, initial measurement: sum of the measurements from the most center of gingival margin to MGL of both buccal and lingual keratinized tissue; t1, measurements 60 days after tooth extraction; t2, measurements
90 days after tooth extraction; t1 − t0, increase of the zone of keratinized tissue after 60 days post-extraction; t2 − t0, increase of the zone of keratinized tissue 90 days post-extraction.
292 EVALUATION OF A DENSE PTFE MEMBRANE TO INCREASE KERATINIZED TISSUE  BARBOZA ET AL

Table 2. Control Group Description and Measurements

t0 t1 t2 t1 − t0 t2 − t0 t2 − t1
Patient Gender Age Tooth (mm) (mm) (mm) (mm) (mm) (mm)
1 F 43 30 8 12 11 4 3 −1
2 F 43 31 7 10 9 3 2 −1
3 F 43 18 9 12 11 3 2 −1
4 F 45 30 10 11 11 1 1 0
5 F 45 29 7 10 9 3 2 −1
6 M 45 31 8 10 8 2 0 −2
7 M 56 30 4 2 2 −2 −2 0
8 F 32 29 7 10 8 3 1 −2
9 F 20 19 10 11 10 1 0 −1
10 F 20 30 11 14 12 3 1 −2
11 F 40 30 10 14 13 4 3 −1
12 F 40 31 10 14 13 4 3 −1
13 F 40 18 9 13 12 4 3 −1
14 F 41 30 11 13 12 2 1 −1
15 F 40 29 8 10 9 2 1 −1
Mean 39.53 8.6 11.06 10 2.46 1.4 −1.06
Minimum 20 4 2 2 −2 −2 −2
Maximum 56 11 14 13 4 3 0
SD 9.33 1.88 2.96 2.77 1.59 1.40 0.59
t0, initial measurement: sum of the measurements from the most center of gingival margin to MGL of both buccal and lingual keratinized tissue; t1, measurements 60 days after tooth extraction; t2, measurements
90 days after tooth extraction; t1 − t0, increase of the zone of keratinized tissue after 60 days post-extraction; t2 − t0, increase of the zone of keratinized tissue 90 days post-extraction.

Table 3. Statistical Analysis Results In contrast, the high-density struc-

ture of d-PTFE reduces the risk of
Shapiro-Wilk Mann-Whitney bacterial penetration through the mem-
t Group n P df Mean Rank P brane, thus eliminating the need for
t0 Test 15 0.339 15 18.47 0.60 primary closure.22 Therefore, the devel-
Control 15 0.151 15 12.53 opment of large flaps and vertical
t1 Test 15 0.347 15 21.67 ,0.05 releasing incisions to achieve primary
Control 15 0.001 15 9.33 closure are not required. In this study,
t2 Test 15 0.476 15 21.77 ,0.05 clinical observations showed that there
Control 15 0.011 15 9.23 were no signs of postoperative wound
t0, initial measurement: sum of the measurements from the most center of gingival margin to MGL of both buccal and lingual
infection, and the tissue surrounding the
keratinized tissue; t1, measurements 60 days after tooth extraction; t2, measurements 90 days after tooth extraction. intentionally exposed membranes was
found to be healthy.
between test and control groups (P , oral cavity, is that the highly porous In this study, tooth extraction was
0.05) for t1 and t2. Note that the initial areas of the membrane, if exposed, are performed, endeavoring to keep all
measurement (t0) presented no signifi- vulnerable to heavy bacterial coloniza- bone walls intact in both groups. In
cant difference between groups tion. This bacterial contamination may addition, in the test group, d-PTFE
(Table 3). result in infection and soft-tissue com- membrane was placed with no bioma-
plications,24–26 which may compromise terial filling the sockets. The architec-
the results of the regeneration procedure ture of the existing bony walls was
DISCUSSION or result in a total failure of the sufficient to maintain the clot and
This clinical study demonstrated procedure. support d-PTFE membrane in place,
that the use of a d-PTFE membrane, Therefore, to achieve predictable preventing a possible collapse of the
without primary closure, allowed a sig- results, e-PTFE membranes are required membrane. These results are in agree-
nificant increase of the zone of kerati- to remain completely covered by the soft ment with a study29 that also used
nized tissue after tooth extraction. tissues for a period of time sufficient to d-PTFE membranes without graft ma-
In the last decade, a host of mem- allow bone regeneration and matura- terials in alveolar sockets exhibiting all
brane materials including e-PTFE tion.27 It is precisely this requirement bone walls.
membranes, collagen, and resorbable for primary closure that makes e-PTFE In the test group, the membrane
polymers have been used in guided bone and many resorbable membranes unsuit- was removed 28 days after surgery.
regeneration. Among the disadvantages able for use to cover extraction sites This protocol was based on a variety of
of e-PTFE, used as a biomaterial in the where they may become exposed.21,28 studies21,22,24,29–32 in which membrane

removal occurred between 21 and 28
days. However, the optimum time for
membrane removal is still controver-
sial. An animal study33 reported no sig-
nificant difference in regenerative
results when nonresorbable barriers
were removed after 1 month and when
they were removed after longer periods.
Another advantage of d-PTFE
membranes is that the high density of
this material makes membrane removal
easy, avoiding the need for a difficult
second surgery. Removal is simplified
by the fact that the membrane is already
exposed and visible at the surgical site,
and no local anesthetic or flap dissec-
tion is required. In this study, mem-
branes were easily removed with no
injuries to the underlying neoformed
tissues or discomfort to patient.
In this study, data analysis showed
an increase of the zone of keratinized
tissue in both groups. However, soft
tissue enhancement was higher in the
test group, with a mean increase of
7.06 6 2.63 mm, whereas in the control
group the mean was 2.46 6 1.59 mm,
after 60 days (t1 − t0). The results of this
study are in agreement with previous
studies that demonstrated the high pre-
dictability of using d-PTFE membranes
in alveolar ridge maintenance with con-
comitant increase of the zone of kerati-
nized tissue.22,24,32,34
It is known that techniques used to
achieve primary closure over e-PTFE or
resorbable membranes contribute to the
loss of keratinized tissue. In contrast,
the use of d-PTFE membranes without
primary closure allows the clinician to
preserve or to increase the zone of
keratinized tissue over extraction
sites.34 This study showed that it is pos-
sible to increase the keratinized tissue
zone in preparation for implant place-
ment. A recent study8 showed that
patients presenting thin periodontal
phenotype had 4.5 times greater proba-
bility to present periimplant disease. In
addition, a lack of keratinized mucosa
surrounding an implant was associated
with more plaque accumulation, tissue
inflammation, mucosal recession, and
loss of attachment.35 Nevertheless,
ridge maintenance procedure using
intentionally exposed d-PTFE mem-
branes leads to keratinized tissue for-
mation, preparing the post-extraction
IMPLANT DENTISTRY / VOLUME 23, NUMBER 3 2014
sites to implant placement, with less
risk of periimplant disease.
CONCLUSIONS
The use of d-PTFE membranes,
intentionally exposed in post-extraction
sites, predictably led to an increase of the
zone of keratinized tissue. Post-extraction
sites with d-PTFE membranes showed
higher keratinized tissue formation than
sites that did not receive the membrane.
DISCLOSURE
The authors claim to have no
financial interest, either directly or
indirectly, in the products or informa-
tion listed in the article.
ACKNOWLEDGMENTS
The authors thank Osteogenics
Biomedical for providing the d-PTFE
membranes.
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