J Clin Periodontol 1997: 24: 747-752 ' Copyright Munki^gaard 1997

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1SS.\- 0303-6979

Clinical comparison of Raui G, Caffesse, Luis F, Mota,

Carlos R, Quifiones and
Edith C. Morrison

resorbable and non-resorbable ^The University of Texas-Houston, HeaHh

Science Center, Dental Branch. Department of
Stomatology. Division ot Periodontlcs.
6516 John Freeman Avenue. Rm 309, Houston,

barriers for guided periodontal TX 77030-3402. USA

tissue regeneration
Caffesse RG, Mota LF, Quinones CR, Morrison EC: Clinical comparison of
resorbable and non-resorbable barriers for guided periodontal tissue regeneration,
J Clin Periodontol 1997: 24: 747-752, Munksgaard, 1997.

Abstract. The purpose of this study was to compare the clinical results of guided
periodontal tissue regeneration (GPTR) using a resorbable barrier manufac-
tured from a copolymer of polylactic and polyglycolic acids (Resolut Regenera-
tive Material) with those of non-resorbable e-PTFE barrier (Gore-Tex Peri-
odontal Material). 12 subjects participated. 6 with similarly paired class II fur-
cations and 6 with 2 similar 2, 3-wall periodontal lesions. The resorbable and non-
resorbabie barriers were randomly assigned to 1 defect in each subject. Non-
resorbable barriers were removed in six weeks. Plaque index (Pll), gingival index
(GI). probing depth (PD), clinical attachment level (CAL) and gingival recession
(R) were recorded at baseline, (i,e., immediately prior to surgery) and at 12 months
postsurgicaJly. The clinical healing was similar and uneventful in both groups.
Intrabony pockets depicted significant changes from baseline (jt)<0.05) for prob-
ing depth reduction and gain in clinical attachment levels. No differences were
found between treatments. Class 11 furcations showed signficant improvements
Key words: guided tissue regeneration;
from baseline (p=s0.05) for probing depth reduction and clinical attachment gain. resorbable membranes: clinical evaluation:
No differences were detected between treatments. It is concluded that the re- e-PTFE: non-resorbable membranes: PLA-PGA
sorbable barrier tested is as effective as the nonresorbable e-PTFE barrier for the copolymer
treatment of class II furcations and intrabonv defects. Acoepted for publication 28 February 1997

Guided periodontai tissue regenera-
tion(GPTR) has been successfully ap-
plied in clinical periodontai therapy
since 1982 (Nyman et al. 1982, Gottlow
et al. 1986. Becker el al. 1987. Nyman
et al 1987). The basic principle behind
tbe concept of GPTR is that the post-
treatment clinical results achieved are
dependent on the source from which the
cells repopulating the exposed root sur-
face and adjacent bony defect originate.
To date, a non-resorbable expanded
polytetrafluorethylene material (e-
PTFE) (i.e., Gore-Tex Periodontal
Material, W.L. Gore & Associates, Inc.,
FlagstafT, AZ, USA) has been widely
used for periodontal regenerative pro-
cedures, fhis material has been shown
to he safe and effective in the treatment
of class II furcation and intrabony peri-
odontal defects (Gottlow et al. 1986;
Caffesse & Becker 1991: Caffesse et al.
1990b; Cortellini et al 1993b; Machtei
et al. 1993). Although this material pos-
sesses the ideal characteristics of a bar-
rier (i.e.. biocompatibility, cell occlusiv-
ity, space making properties, ability to
stabilize the surrounding tissues during
healing, and the capacity to limit epi-
thelial migration) (Scantlebury 1993), a
second surgical procedure is necessary
for its retrieval due to its non-resorb-
ability. Due to this, a series of biore-
sorbable materials have been the object
of intensive research during recent years
(Blumenthal 1993; Chang et al. 1990;
Fleischer et al. 1988; Minabe et al.
1989; Kodama et al. 1989; Pitaru et al.
1987; Blumenthal 1988; Chung et al.
1990; Hugoson et al. 1995; Van Swol et
al. 1992; Blumenthal 1993b).
Recently, a bioresorbable barrier (Re-
solut Regenerative Material, W.L.
Gore & Associates. Inc.. Flagstaff. AZ,
USA) has been manufactured following
the design criteria used for the non-re-
sorbable barrier. This newly developed
resorbable barrier is composed of a syn-
thetic copolymer of polyglicolic and
polylactic acids (i.e. copolymers which
have a history of safe use as bioabsorb-
able sutures and surgical meshes). The
polymer components of this barrier hy-
drolyze, are safely resorbed in body
tissue and have been found to be inert,
nonantigenic, nonpyrogenic and elicit
only a mild tissue reaction during bi-
 748 Caffesse et al.

oabsorption. Histological and histo-

metrical evaluation of this bioresorb-
abie barrier in beagle dogs found com- 1 RESOLUT (n= 12)
parable results to those achieved with
the non-resorbable e-PTFE barrier. I3 GORE-TEX (n= 12)
Evaluations performed at 1, 3, and 6
months, demonstrated a minimal in- 9 16 1.7
1,5 1.5 1,5

11
flatnmatory reaction and the refor- a 1,4
mation of a connective tissue attach-
ment with these barriers. New ce-
mentum with inserting collagen fibers
occurred on the previously denuded
root surfaces isolated by either the non-
resorbable or the resorbable barriers
(Caffesse et al. 1994; Warrer et al.
1994). Furthermore, studies in monkeys Ba.seline Avg of I si 8 wks 12 Months
by Quinones et al, (1994) and Huerzeler sd = .5 / ..S stl = .3 / .4 sd = .5 / .5
et al. (1994) proved the benefits of this
barrier in facilitating periodontal re- Fig. J. Oral hygiene. Comparison of Resolut* regenerative material and Gore-Tex''^" regenera-
tive material.
generation when compared to open flap
debridement in interproximal intrabony
defects and class II furcations, respec-
tively.
This resorbable barrier, has been al-
ready approved by the FDA for GPTR RESOLUT ( n = 12)
procedures, and has been on the market
for some time in the USA and several D GORE-TEX ( n = 12)
countries of Europe. The purpose of the 2 --
present study was to evaluate the clin- 73
ical response and efficacy of this re-
I

m
sorbable barrier and to compare it to 1.1
the proven non-resorbable e-PTFE bar- 1.0 1.0
rier in the treatment of Class II fur- 5 0.7
cations and intrabony periodontai
lesions in htmians.

Material and Methods Baselitie l2Motiths

12 adult patients, 6 males and 6 female, sd = .6 / .6 sd = .6/.6
with a mean age of 42 years (range; 21 Fig. 2. Gingival inflammation. Comparison of Resolut* regenerative material and Gore-Tex^"
to 59) participated in this study. All pa- regenerative material.
tients were treated in the Department of
Stomatology, Division of Periodontics
at the University of Texas-Houston,
Health Science Center. The protocol
was reviewed and approved by the Insti-
tution's Cotnmittee for the protection RESOLUT (n = 6)
- 7.5 7.4
of human subjects. C OORE-TEX (n = 6)
Patient selection criteria included 7
general good health, with the presence 6
of bilaterally sitnilar mandibular class 5
II furcations or maxillary or mandibu- 4 3.8 3.7
3.0

I
lar intrabony 2, 3-wall periodontal de- 3
fects. In addition the probing depths 2.3
and attachment loss of the sites to be
treated had to be equal to or greater
than 5 mm, with radiographic evidence
2
I
0
Baseline PD PD Reduction
Ji Attachment Gain
sd = 2.0 /1.2
1.5
HH

Recession
0.7

sd = l . 6 / l . l
of bone loss, and an absence of peri- sil=l.9/l.5 sd= 1.2/1.2
odontal and endodontai abscesses, as t = .l4 t = .28 t = .67 t = .79
well as no previous history of peri- p = .90 p = .79 p = .46
odontal surgery in the areas. Patients Fig. 3. Clinical results with Resolut* regenerative material and Gore-Tex^" regenerative ma-
with a history of rheumatic fever, valvu- terial. 12-month comparison - intrabony defects (mean of defect).
lar heart disease, or orthopedic replace-
 Resorbable and non-resorbable barriers 749

10 dental papillae. The granulation tissue

9 was removed and the root surfaces were
RESOLUT (n = 6)
8 scaled and planed with hand, ultrasonic
D GORE-TEX (n = 6)
7 ~ 6 ^ and rotary instruments. Defects were
: 6 randomly assigned to receive treatment
with either the non-resorbable or re-
= 5
sorbable barrier.
4
Selection of barrier configuration
3
2
I
0
: 1
Baseline PD
2.5 2.6 2.4

.Bn, o...ri,ll
PD Reduction Attachment Gain Recession
2.3

,sd = 1.2 / .7 sd=l.()/,7
t = 2.1 t = .2l
p = .(W p=.R4
Fig. 4. Clinical results with Rfisolut* regenerative material and Gore-Tex^'^ regenerative ma-
terial. 12-month comparison - II furcation defects (mean of defect).
ments were not included in the study.
All patients qualifying for the study
were informed of the nature of the pro-
ject and signed a consent form.
The subjects received initial peri-
odontal therapy consisting of scaling
Horiz Gain
was based on defect topography. The
barriers were trimmed with scissors to
cover at least 2-3 mm beyond the defect
margins. The material was stabilized
with a circumferential suture. The bi-
.^d= (.0/1,7 sd=f,3/l.9 sd = , K / i , 0
oresorbabie material was tied in place
t = 1.5 t = I.I t = 1.0
P = 19 p = .32 p = 36
tightly using a commercially available
bioresorbable suture (Resolut re-
sorbable suture, W.L. Gore & Associ-
ates, Inc., Flagstaff, AZ, USA) while
the non-resorbable material was se-
cured using an e-PTFE suture. The
and root planing and oral hygiene in- flaps were then repositioned. to cover
structions. Periapical radiographs of the membranes and sutured using e-
the teeth to be treated were also taken. PTFE sutures.
The area of treatment was anesthetized Following all surgical interventions
and mucoperiosteal flaps were elevated the patients were prescribed a mouth
maintaining the integrity of the inter- rinse containing 0.12% chlorhexidine

fig, 5. (a) Surgical view of 2-3 wall intrabony defect with probe in place (13 mm mark at bone crest), (b) Resolut resorbable membrane in
place, (c) 18 months post-operative view, (d) Upon reentry at 18 months post operatively bone fill is readily observed.
 750 Caffesse et al.
gluconate (Peridex, Procter & Gamble,
Cincintiati, OH, USA) for 2 weeks. The
noti-resorbable barriers were removed
after 6 weeks, and the patients were
monitored at land 2 weeks, and at 1,2,
3. 6, 9 and 12 months. Immediately
prior to surgery, and at 12 months, the
surgical sites were scored for; plaque
using a modified plaque index (Sil-
ness & Loe 1964) and gingivitis using a
modified gingival index, (Loe & Silness
1962) as well as measured for probing
depth (PD), clinical attachment level
(CAL), (Ramfjord 1967) and also hori-
zontal attachment level in the furcation
defects, using a UNC-15 periodontal
probe or a Nabers probe (Hu-Friedy,
Co,, Chicago, IL, USA) which marks
were corroborated for calibration under
a microscope. In each defect the PD,
and CAL were measured at 3 locations
and each value was taken and averaged
to obtain a mean value for the defect.
For furcations these measurements cor-
responded to the middle of the fur-
cation, and the mid-root portions of the
mesial and distal roots. For intrabony
defects, these corresponded to the
middle of the defect and the adjacent
line angles of the teeth. For statistical
evaluation the means of the defects, as
well as the deepest measurements re-
corded were considered. Pair r-tests
were used to evaluate changes for each
technique from baseline to 12 months,
and also to compare the results
achieved with both barriers.
Results
All areas treated healed uneventfully. Of
the 12 subjects treated, 6 presented a
pair of similar 2, 3-wall intrabony de-
fects, and 6 depicted similar class II fur-
cation defects. The sample consisted of
6 females and 6 males, with a mean age
of 42 years of age. The level of oral hy-
giene of the patients was similar for
those areas treated with either the re-
sorbable or non-resorbable barriers.
Fig. I shows the mean plaque index
scores for both groups at baseline, 8
weeks and 12 months post treatment.
No significant differences were found.
Fig. 2 shows the mean gingival in-
flammatory response as evaluated by
the gingival index at baseline and 12
months. No differences were found.
Figs 3, 4 present the clinical results
achieved with the use of the resorbable
and non-resorbable barriers in the
treatment of the intrabony defects, and
class II furcation defects respectively
considering the mean value for the de-
fect. No differences between the two
sample populations were found at base-
line. Both treatment approaches pro-
duced statistically significant changes
from baseline (/i<0.05) in probing
depth reduction, gain in clinical attach-
ment levels, and gain in horizontal clin-
ical attachment level (i.e., in class II fur-
cations).
When the results were compared be-
tween procedures, (i.e., resorbable ver-
sus non-resorbable), no significant dif-
ference was found in any of the par-
ameters tested, as indicated in the
figures. In addition to the mean of the
measurements recorded in each defect
the results were also evaluated consider-
ing the deepest probing measurement
recorded in the defect. The results ob-
served follow in general the same pat-
tern previously described. Both treat-
ments produced significant improve-
ments from baseline (/i<0.01) in
probing depth reduction, and gain in
clinical attachment. No statistical dif-
ferences were found when results were
compared between treatments.
When the effect of membrane ex-
posure on clinical attachment gain for
resorbable and no-resorbable mem-
branes, was evaluated, no differences in
results were found (/i>0.05), (5 re-
sorbable and 8-non-resorbab!e mem-
branes exposed). Smoking did not seem
to be a variable that influenced material
exposure. Six smokers and 7 non-
smokers showed membrane exposure.
However, when the subjects were separ-
ated in smokers and non-smokers, non-
smokers seemed to gain more clinical
attachment (3.1 mm vs 1.9 mm) al-
though the difference did not reach sig-
nificance in this sample size (/>>0.05),
Discussion
The purpose of the present study was
to evaluate the clinical response and ef-
ficacy of a bioresorbable barrier (i.e.,
Resolut Regenerative Material), for
GPTR in 2, 3-wall intrabony defects
and Class II furcations, and to compare
these results with those achieved when
using the gold standard, non-resorbable
e-PTFE barrier. The present findings
show that one year after treatment the
results achieved with both barriers are
comparable in every parameter evalu-
ated, since no statistical significant dif-
ference was found. Both barriers were
effective in achieving the clinical objec-
tives of GPTR. When the results were
evaluated within each group, both the
resorbable and non-resorbable barriers
produced significant reductions in prob-
ing pocket depth, and gains in clinical
attachment level. Furthermore, when
furcations were evaluated, the horizon-
tal clinical attachment level increased
significantly The clinical values ob-
tained agree with previous reports in
the literature which indicate favorable
results when GTR was used in the treat-
ment of either intrabony defects or class
II furcations (Becker et al, 1988; Becker
and Becker 1993; Caffesse et al. 1990;
Cortellini et al. 1993: Lekovic et al.
1989; Pontoriero et al. 1988; Hugoson
et al. 1995).
In a recent publication, Becker et al.
(1996) reported on the results of a
multicenter study evaluating the re-
sponse to therapy of intrabony defects
and class II furcations using the same
PLA/PGA barrier tested in this study.
In 30 intrabony defects treated, a mean
probing depth reduction of 4.0 mm,
and 2.9 mm of clinical attachment level
gain was found 1 year after treatment.
The 31 class II furcations treated de-
picted 2,5 mm of probing depth reduc-
tion and 2.1 mm of gain in clinical
attachment levels. The values achieved
in the present study agree with those
published by Becker et al. (1996).
In a previous investigation in beagle
dogs, Caffesse et al, (1994) demon-
strated clinically and histologicaliy that
this resorbable barrier was well toler-
ated by the periodontal tissues. By 30
days, the barrier's surface exhibited a
small degree of undermining with in-
corporation from the surrounding peri-
odontal connective tissues, (i,e,, the
connective tissue of the flap on the out-
side, and the newly regenerated connec-
tive tissue which occupied the space
created by the barrier on the inside), A
recent study from our laboratory (Ver-
gara et al. 1997) evaluated vascular
healing following the use of this re-
sorbable barrier and the non-resorbable
barrier, and demonstrated that early in
the healing process new capillaries grow
from both sides towards the barrier and
invade it. The inflammatory response
generated by this barrier during the
process of resorption is minimal and
appears to be localized to tbe immedi-
ate vicinity of the barriers (Caffesse et
al, 1994; Warrer et al, 1994; Vergara et
al. 1997), The presence of this mild lo-
calized inflammatory reaction does not
seem to compromise the clinical or his-
tological results achieved.

The clinical behavior of this re-
sorbabJe membrane indicates that it ful-
fills all the basic characteristics required
from a GPTR barrier (Scantlebury
1993). It exhibits biocompatibilty due
to the uneventful clinical response of
the periodontal tissues. Furthermore,
from a clinical and practical standpoint,
the barrier was easy to adapt, trim, and
suture to the tooth. It fulfilled the user-
friendly requirements.
Finally, it was the clinical impression
of the authors that this resorbable
membrane was stiff enough to maintain
a space underneath when there was suf-
ficient support by the adjacent bony
walls and root surface. After suttjring
the material did not collapse and main-
tained its shape in position. Presently,
instances where there is insufficient sup-
port, and the non-resorbable mem-
branes are the norm, one may opt to
use a titanium reinforced barrier to
maintain space. If. otherwise, a Reso-
lut resorbable barrier is used, this may
require the use of a biocompatibie filler
to assure the spacemaking capabilities,
and thus avoiding its collapse within the
defect. Clinical studies to evaltjate these
possibilities and to clearly draw specific
indications for each type of barriers are
needed, and are currently in progress.
In the present study, during the im-
mediate post-operative time, practically
a similar number of barriers exhibited
exposure (5 resorbable and 8 non-re-
sorbable) and non-exposure (7 re-
sorbable and 4 non-resorbable) and
there was no apparent effect on the clin-
ical attachment level outcome (p>0,05).
However, the number of cases in the
present study may turn out to be too
few to evaluate the effect of barrier ex-
posure, or it may very well be that if
barriers are exposed, but the oral hy-
giene and gingival inflammation are
controlled, the exposure does not sig-
nificantly affect the healing process tak-
ing place underneath the barriers.
This study has shown the clinical re-
sponse and efficacy of this resorbable
barrier in the treatment of periodontal
defects (Fig. 5), These results were simi-
lar to those achieved with the non-re-
sorbable e-PTFE barrier. The prospect
of using a resorbable barrier is appeal-
ing since it will avoid additional
surgery. Because of this the use of a re-
sorbable barrier is more cost effective
than the use of a non-resorbable barrier
and is also usually better accepted by
the patient. Furthermore, avoiding the
second surgery means that the newly re-
Resorbable and non-resorbable barriers
generated periodontai tissues will not
be disturbed, giving the opportunity for
further undisturbed maturation and or-
ganization. In summary, the histologic
evidence of periodontal regeneration
found in previous animal investigations
combined with the clinical findings of
this present trial support the use of this
bioabsorbable barrier for the treatment
of class II furcations and intrabony
periodontal lesions. The reduced num-
ber of cases, however, needs to be ac-
knowledged. Further studies evaluating
the response of larger populations are
required. Additionally, studies evalu-
ating the use of this barrier in combi-
nation with bone grafts are now in pro-
gress.
Acknowledgment
This project was partially ftinded by W,
L. Gore & Associates, Inc., Flagstaff,
AZ, USA.
Plaque (PII). I'lndice Gingiva! (GIj. la pro-
Zusammenfassung
Klinischer Vergleich von resorbierbaren und
nichtresorbierbaren Membran ftir die gesteu-
erte parodontale Geweberegeneration
Der Zweck dieser Studie war es. die klini-
schen Ergebnisse der gesteuerten parodonta-
len Geweberegeneration (GPTR) unter Ver-
wendung einer resorbierbaren Membran. die
aus einem Kopolymer aus Polylaktit- und
Polyglykolsaure hergestellt ist (Resolut*).
mtt denen einer nichtresorbierbaren e-PTFE-
Membran (Gore-Tex*) zu vergleichen. An
der Studie nahmen 12 Patienten teil. 6 mit
vergleichbarem Grad 11 Furkationsbefall
und 6 vergleichbaren dreiwandingen Kno-
chentaschen. Die resorbierbaren und die
nichtresorbierbaren Membranen wurden
randomisiert je einem Defekt pro Patient zu-
geteilt. Die nichtresorbierbaren Membranen
wurden nach 6 Wochen entfernt, Plaque-In-
dex (PU) Gingiva-Index (GI). klinisches At-
tachmentniveau (CAL) und Gitigivarezessio-
nen (R) wurden zu Begirjn der Studie (unmit-
telbar vor der Chirurgie) und 12 Monate
nach der Chirurgie gemessen. Die klinische
Heilung war in beiden Gruppen ahnlich und
ohne Zwischenfalle. Die Knochentaschen
zeigten signifikante Veranderungen (p<0.05
bezilglich der Reduktion der Ausgangswerte
fiir Sondierungstiefe und einen Gewinn an
klinischem Attachmentniveau. Zwischen den
Behandlungen wurden keinen Unterschiede
gefunden. Die Furkationen mit Grad II zeig-
ten signifikante Verbesserungen (p<0,05) be-
ztiglich der Ausgangswerte fur Sondierungs-
tiefe und des klinischen Attachmentniveaus.
Zwischen den Behandlungen wurden keine
Unterschiede gefunden. Es wird die SchluB-
folgerung gezogen. dafl die getesteten resor-
bierbaren Membranen hinsichtlich der Be-
handlung von Eurkationsbefall Grad II und
751
voD Knochentaschen genauso wirkungsvoll
sind wie die mchtresorbierbaren e-PTFE-
Membranen.
Resume
Comparaison dinique de barrieres resorhables
et non resorbabks pour la regeneration guidee
des tissus parodontaux
Le but de cette etude etait de comparer les
resultats cliniques de la regeneration guidee
des tissus parodontaux {GPTR) pratiquee en
utilisant une barriere faite d'un copolymere
d'acides polylactique et polygiycolique (Re-
solute* Regenerative Material) avec les resul-
tats obtenus en utiiisant une barrjere non re-
sorbable d'e-PTFE (Gore-Tex* Periodontal
Material). L'etude portait sur 12 sujets, 6
sujets ayant des lesions similaires appariees
des furcations de ciasse II et 6 sujets ayant
deux lesions parodontales similaires a 2 et 3
parois. Les barrieres resorbables et non re-
sorbables ont ete assignees par tirage au sort
a une lesion chez chacun des sujets. La depo-
se des barrieres non resorbables a ete faite a
6 semaines. L'enregistrement de ITndice de
fondeur au sondage (PD). le niveau clinique
de l'attache (CAL) et la recession gingivale
(R) a ete pratique au debut (baseline, imme-
diatement avant l'intervention chirurgicale)
et 12 mois apres intervention. La cicatrisa-
tion ciinique etais sans incident et semblable
dans les deux groupes. Pour les poches infra-
osseuses, la reduction de la profondeur au
sondage et le gain de niveau clinique de Tat-
tache representaient des changements signi-
ficatifs par rapport au debut (;><0,05). On
n'a constate aucune difference entre les trai-
tements. Les furcations de ciasse II presen-
taient des ameliorations significatives par
rapport au debut (;JS0.05) pour la reduction
de la profondeur au sondage et !e gain clini-
que d'attache. Aucune difference n'a ete ob-
servee entre les traitements. En conclusion, la
barriere resorbable testee etait aussi efficace
que la barriere non resorbable d'e-PTFE
pour le traitement des furcations de ciasse II
et des lesions infra-osseuses.
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Address:
RaulG. Caffesse
The University of Texas-Houston
Health Science Center
Dental Branch
Department of Stomatology
Division of Periodontics
6516 John Freeman A venue, Rm 309
Houston. TX 77030-3402
USA