J Clin Periodontol 2003; 30: 386–393 Copyright r Blackwell Munksgaard 2003

Printed in Denmark. All rights reserved

Comparison of infrabony defects Maurizio Silvestri1, Stefano Sartori1,

Giulio Rasperini2, Giano Ricci3,
Chiara Rota1 and Vitaliano Cattaneo1

treated with enamel matrix

1
Department of Periodontology, IRCCS
Policlinico S. Matteo, University of Pavia,
Italy; 2Dental Clinic, Department of
Periodontology, University of Milan, Italy;
derivative versus guided tissue 3
Private practice, Florence, Italy

regeneration with a
nonresorbable membrane
A multicenter controlled clinical trial
Silvestri M, Sartori S, Rasperini G, Ricci G, Rota C, Cattaneo V. Comparison of
infrabony defects treated with enamel matrix derivative versus guided tissue
regeneration with a nonresorbable membrane. A multicenter controlled clinical trial.
J Clin Periodontol 2003; 30: 386–393. r Blackwell Munksgaard, 2003.

Abstract
Aim: The purpose of the present multicenter clinical trial was to compare the efficacy
of two different procedures in the treatment of infrabony defects: guided tissue
regeneration (GTR) with nonresorbable membranes and enamel matrix derivative
(EMD).
Material and methods: Six centers participated in this study. Ninety-eight
patients with an interproximal infrabony defect were selected. All patients
were treated with an initial phase of scaling and root planing, and at the study’s
baseline the selected defects presented a value of probing depth (PD) X6 mm
with an infrabony component X4 mm. Forty-nine patients were treated
with GTR procedures (using ePTFE membranes (Gore-Tex W.L. Gore and Associates,
Flagstaff, AZ, USA)) and forty-nine with EMDs (Emdogains (Ü Biora AB Malm,
Sweden)). The efficacy of each treatment modality was investigated through
covariance analysis.
Results: The patients were reevaluated at one year postop. Probing attachment level
(PAL) gain and PD reduction were analyzed. In the Emdogains group the PAL before
surgery (PAL 0) and the PD before surgery (PD 0) were respectively 9.971.4 and
8.571.6 mm. The PAL gain and the PD reduction at 1 year postsurgery were
respectively 4.171.8 and 5.371.9 mm. The group of patients treated with
membranes showed that PAL 0 and PD 0 were respectively 8.971.9 and 8.171.9.
The PAL gain was 4.371.9 mm and the PD reduction was 5.671.5 mm. The mean
PAL gain expressed by percentage (PAL gain/PAL 0) for the group treated with EMD
was 41%, while it was 48% for the group treated with GTR. Results from our
analysis suggest that there is no statistically significant difference between GTR and
EMD treatments in terms of PAL gain, PD reduction and recession variation.
Applying the regression model to a group of patients with a PAL 0 X8 mm, we
Keywords: enamel matrix derivative;
observed a better clinical outcome in terms of PAL gain (difference of 0.3 mm) in periodontal regeneration; infrabony defects;
patients treated with the GTR procedure compared to those treated with EMD. guided tissue regeneration; flap design;
Covariance analysis showed a strong correlation in both groups of patients between membrane exposure
PAL gain and full mouth bleeding score, and between PAL gain and defect
morphology and depth. Accepted for publication 6 May 2002

Ever since Nyman et al. (1982a, b)
demonstrated that it is possible to obtain
new attachment with guided tissue
regeneration (GTR), many authors have
reported successful treatment of infrab-
ony defects using GTR procedures
(Becker & Becker 1993, Cortellini et
al. 1993a, b, Cortellini et al. 1995a,
Weltman et al. 1997). This surgical
technique presents some technical diffi-
culties and potential complications: the
shaping and adaptation of the mem-
brane to the root surface, particularly in
posterior teeth, may require sophisti-
cated surgical skills. Complete coverage
of the membrane after its placement and
during tissue healing requires careful
soft tissue management. Exposure of
membranes to the oral environment is a
frequent complication and is a possible
cause of contamination and infection of
the newly formed tissue under the
membrane (Selvig et al. 1990, Tempro
& Nalbandian 1993, Nowzari & Slots
1994, Simion et al. 1994, Ricci et al.
1996, Zucchelli et al. 1997). Several
studies indicate that the outcome of
GTR procedures can be altered by
bacterial contamination (Selvig et al.
1992, Mombelli et al. 1993, Sander &
Karring 1995, Smith-MacDonald et al.
1998, Yoshinari et al. 1998). Some
recent experiments have elucidated the
role of enamel matrix proteins in the
development of periodontal tissues and
their effectiveness in the regeneration of
the periodontium (Gestrelius et al.
1997a, b, Hammarström 1997, Ham-
marström et al. 1997, Mellonig 1999)
and in improving clinical attachment
level in humans (Heijl et al. 1997,
Heden 2000, Mellonig 1999, Pontoriero
et al. 1999, Sculean et al. 1999, Okuda
et al. 2000, Silvestri et al. 2000, Sculean
et al. 2001). The present multicenter
controlled clinical trial follows upon a
pilot study (Silvestri et al. 2000) in
which we observed a significantly better
clinical outcome in terms of PAL
gain for both regenerative procedures,
ePTFE membranes (Gore-Tex W.L.
Gore and Associates, Flagstaff, AZ,
USA) and Emdogains (Ü Biora AB
Malm, Sweden), with respect to the
Widman flap procedure. However, the
results of the previous study called for
further evaluation because the analysis
of its results was limited to a relatively
small number of patients. The main
purpose of the present study was to
evaluate the clinical efficacy of GTR
procedures compared to enamel matrix
derivative (EMD) procedures. Another
Periodontal regeneration with EMD
objective was to evaluate the influence
of varying baseline conditions on the
outcome of both study groups.
Material and Methods
Patient and selected site description
The goal of this multicenter clinical trial
was to compare the results obtained in
the treatment of infrabony defects
utilizing GTR and Emdogains thera-
pies. The investigation was conducted
in accordance with the Helsinki declara-
tion (Declaration of Helsinki; 18th
World Medical Assembly 1964; re-
ceived 35th World Medical Assembly,
Venice 1983) on experimentation invol-
ving human subjects (1975). Informed
consent for participation in this study
was obtained from all patients.
The control group underwent GTR by
means of membranes in ePTFE while
the test group was subjected to a
protocol with Emdogains. The patient
population was recruited in a total of six
centers (one university setting and five
private practices) with specific experi-
ence in the use of Emdogains and GTR
procedures. Patient selection had to be
confirmed within 6 months of the
beginning of the selection process.
Group assignment was determined by
central randomization using balanced
random permuted blocks.
One hundred patients were selected
(50 treated with GTR and 50 with
EMD) according to the following criter-
ia:
1. AgeX21 years.
2. Goodgeneral health.
3. Womennot pregnant or lactating.
3. Nonsmokers and light smokers
(o10 cig./day).
4. Presence of severe periodontitis
treated with scaling and root plan-
ing and oral hygiene instructions.
5. Full-mouth plaque score (FMPS)
(O’Leary et al. 1972) and full-
mouth bleeding score (FMBS)
4 25% at study baseline.
6. Presence of a deep infrabony defect
with a PD of 6 mm or more, located
in the interproximal area in anterior
and premolar teeth. Mesial aspect
of the first lower molar, without
furcation involvement, was in-
cluded in the study.
7. Presence of an infrabony compo-
nent of the defect X4 mm, as
assessed by clinical and radio-
387
graphic criteria as suggested by
Björn et al. (1969)
Each patient was treated with an
initial therapy consisting of oral hygiene
instruction, scaling and root planing.
One month after completion of the
initial phase, a reevaluation was per-
formed. Once the patients satisfied all
entry criteria, they were randomly
(Fleiss 1992) assigned to one of two
surgical procedures. Clinical measure-
ments were taken at baseline and at 1
year postop.
At each selected site, PD, PAL and
REC were recorded to the nearest
millimeter using a manual pressure-
sensitive probe (PCP-UNC15, Hu-Frie-
dy, Chicago, IL, USA) calibrated at a
force of 0.25 N.
Flap design
The flap design used in both groups of
patients was based on the technique
suggested by Takei et al. (1989) (papilla
preservation technique) or the technique
suggested by Cortellini et al. (1995b).
The choice of flap design was per-
formed in accordance with the follow-
ing criteria:
 When the defect was strictly inter-
proximal, or interproximal and buccal
Takei et al.’s papilla preservation
technique was performed.
 When the defect was interproximal
and lingual the modified papilla
preservation technique as described
by Cortellini et al. was performed.
 When the interproximal defect was
extended to the lingual and buccal
aspect, the papilla was maintained on
the opposite flap (buccal or lingual)
where the deepest component of the
pocket was located.
Papilla preservation technique
After anesthetizing the area, the extent
of the bone defect is determined by
probing. The extension of the osseous
defect to the palatal or lingual aspect of
the interdental papilla determines the
position of the semilunar incision.
This incision should be at least 3 mm
apical to the margin of the interproximal
bony defect. This ensures that the flap
margin is well away from the area of the
infrabony defect that is completely
covered by intact papillary tissue at
the time of suturing.
388 Silvestri et al.
The intrasulcular incisions extend to
the alveolar crest, avoid compromising
the blood supply to the interdental
papillae and ensure a maximum amount
of tissue interdentally. After completing
the incisions the full thickness flaps can
be reflected.
An interproximal knife is used to
carefully free the interdental papilla
from the underlying hard tissue. It is
important that the interdental tissue,
which is a part of the facial or lingual
flap, is completely free and mobile
before proceeding to the reflection of
the papilla. The detached interdental
tissue is carefully pushed through the
embrasure with a blunt instrument so
that the flap can be easily reflected with
the papilla intact.
The granulation tissue can be re-
moved by means of a curette and the
root surface can be scaled and planed.
Therefore, the proper regenerative pro-
cedure can be performed and the flaps
can be replaced and sutured.
Modified papilla preservation technique
This surgical technique is a variation of
the papilla preservation technique mod-
ified to allow the primary closure, and
the coronal positioning of the interden-
tal tissue. The tissue must be free of
inflammation, and after local anesthesia
the buccal and interproximal intrasul-
cular incision to the alveolar crest,
involving the two teeth neighboring
the defect, can be performed. A hor-
izontal incision with a slight internal
bevel, traced in the buccal gingiva of
the interdental space at the base of the
papilla, allows one to begin to under-
mine the papilla. A full thickness buccal
flap can now be elevated buccally. The
interproximal incision can be continued
intrasulcularly in order to reach the
palatal line angle and extends to the
palatal aspect. By means of an inter-
proximal knife, the supracrestal con-
nective tissue can be separated to the
bone crest and the papilla can be
elevated towards the palatal aspect.
Following extension of the palatal
incision, a full thickness palatal flap
including the interdental papilla can be
subsequently elevated to expose the
interproximal defect completely. The
defect must be debrided and the root
surfaces can be scaled and planed. The
coronal positioning of the buccal flap
without tension can be achieved with
two vertical releasing incisions and with
a periosteal incision placed at the base
of the flap. Therefore, the proper
regenerative procedure can be per-
formed and the flaps can be coronally
replaced and sutured.
Surgical technique in the group treated
with the GTR procedure
Patients were instructed to rinse with
chlorhexidine 0.2% solution for 1 min.
The flap design was executed according
to the above-mentioned criteria.
After the infrabony defect was ex-
posed, it was carefully debrided and
then subjected to scaling and root
planing. The intrasurgical measure-
ments of the defect were then taken.
The root surface of the interested
tooth was treated with a solution of
EDTA (24%) for 2 min (Blömlof et al.
1997). Then the most appropriate Gores
membrane was selected and modeled
for each individual patient. The mem-
brane had to be extended at least 3 mm
beyond the margin of the defect. It was
then attached to the interested tooth by
means of sutures suspended to the two
adjacent teeth. The primary closure of
the interproximal space over the mem-
brane had to be made without tension.
In order to obtain coverage of the
membrane, the buccal flap was posi-
tioned with an inner modified mattress
horizontal suture (Gore-Tex 4-0) be-
tween the buccal and the lingual flap, as
suggested by Gottlow et al. (1994). The
suture had to take anchorage in cher-
atinized mucosa. The interproximal
mesial and distal spaces were sutured
with separated stitches. The interprox-
imal space above the membrane was
closed with separated stitches. Mem-
branes were removed 6 weeks after
placement and flaps were coronally
displaced to obtain complete coverage
of newly formed tissues.
Surgical procedure in the Emdogains
group
The surgical technique used in this
group was the same as that previously
described; however, rather than utilizing
membrane positioning, Emdogains so-
lution was employed.
The root surface of the interested
tooth was treated with a solution of
EDTA (24%) for 2 min (Blömlof et al.
1997). The solution was then washed
out with saline solution for 20 s. Before
application of the Emdogains solution,
the sutures were prepared. They were
then closed after the application of
Emdogains to the root surface. The
gel application was performed with
particular care in order to avoid blood
contamination of the root surface.
Intrasurgical measures
After debridement and cleaning of the
infrabony defect, the following mea-
surements were recorded:
(a) Distance from cementum-enamel
junction (CEJ) to alveolar crest
(CEJ–AC).
(b) Distance from CEJ to the bottom
of the bone defect (CEJ-BD).
(c) Percentage of one-, two-, three-
wall components of the defect. The
infrabony component was divided
into different portions in order to
measure the different number of
walls that the defect was made of.
This measure was expressed in
percentage; i.e. considering an
infrabony component of 10 mm
with a three-wall component of
5 mm, a two-wall component of
3 mm and a one wall component of
1 mm, these measures are ex-
pressed as: three-wall component
50%, 2-wall component 30% and
one-wall component 10%.
Postsurgical follow-up
After surgery, a combination of clavu-
lanic acid and amoxicillin was pre-
scribed (2 g per day for 7 days.
Augmentins).
Both groups of patients were in-
structed to rinse twice a day with 0.2%
chlorhexidine solution in the first 8
weeks. Professional tooth cleaning was
performed weekly for the first 8 weeks.
Patients used modified oral hygiene
procedures, avoiding brushing and using
interdental devices, in treated areas
during the first 2 months postop. All
patients were then placed on a three-
month recall visit up to the 1-year
reevaluation. No attempt at probing or
deep scaling was made before the 1-
year follow-up.
At 1 year postop the final measure-
ments were taken.
Data analysis
The data analysis was based on a
covariance model in order to compare
the Emdogains and the GTR treatments
in terms of their effect on probing

attachment level (PAL). The statistical
model took into account the influence of
the baseline conditions (PAL, PD,
infrabony components of the defects
(INFRA), wall component, FMPS and
FMBS) on the considered outcome
variable (percent PAL gain). The two
treatments were compared in terms of
their impact on PAL gain.
A subsequent analysis of covariance
was undertaken to study possible statis-
tical interaction between treatment ef-
fect and the patients’ baseline
conditions.
Results
Baseline values
Out of the 100 initially selected patients,
98 underwent the protocol: 49 treated
with EMD and 49 with ePTFE mem-
branes. One patient treated with EMD
and one with GTR did not come to the
programmed control 1-year postop for
personal and unspecified reasons. The
percentage of smokers was 36% for the
EMD group and 38% for the ePTFE
population.
The mean age of subjects in the
control group treated with ePTFE (25
females, 24 males) was 49.778.2 years.
In the test group treated with EMD (28
females and 21 males), the mean age
was 47.878 years.
The PAL, PD and recession (REC)
levels at baseline in the Emdogains
group were respectively 9.971.4,
8.571.6 and 1.871.9 mm (Table 1).
In the group treated with ePTFE mem-
branes, the baseline values for PAL
were 8.971.9 mm, PD was 8.17
1.9 mm and gingival recession was
1.171.0 mm (Table 1). The depth of
the INFRA was 6.472.5 in the Emdo-
gains group and 6.171.7 mm in the
ePTFE group.
In the group of patients characterized
by an infrabony defect with a predomi-
nant 3-wall component, the mean PAL
gain was 5.0271.86 mm (21 treated
Table 1. Baseline values for the two groups of treatment
PAL 0
GTR 8.971.9
EMD 9.971.4
p NS
PAL 0: probing attachment level before surgery; PD 0: probing depth before surgery; REC 0 is the
recession of the soft tissues before surgery; INFRA: infrabony component of the defect assessed
during surgery; GTR: guided tissue regeneration treatment; EMD: enamel matrix derivative
treatment.
Periodontal regeneration with EMD 389
with EMD and 24 with GTR). In the increase in PAL of 4.371.9 mm with a
group of patients with an infrabony PD reduction of 5.671.5 mm (Table 3).
component with a predominant one or The mean PAL gain expressed by
two-wall component, the mean PAL percent (PAL gain/PAL 0) for the group
gain was 4.2572.34 mm (28 treated treated with EMD was 41%, while it
with EMD and 25 with GTR). was 48% for the group treated with
The group of patients treated with the GTR.
EMD surgical procedure was character-
ized by the following flap design
distribution: 23 subjects treated with Regression analysis
Takei et al.’s technique and 26 subjects
with the modified papilla preservation There were no marked differences
technique suggested by Cortellini et al. between the two treatment groups with
In the GTR group 27 subjects were respect to the distribution of the base-
treated with Takei et al.’s technique and line variables. However, a regression
22 subjects with the modified papilla modeling approach was performed to
preservation technique suggested by evaluate the influence of the baseline
Cortellini et al. variables on the PAL gain. The data
The subjects were distributed be- were analyzed using regression analysis
tween the centers as shown in Table 2. (Fleiss 1992).
The results of the analysis evidenced
the following findings:
Clinical outcome at 1 year
 There is no global advantage of one
In the Emdogains group, the PAL gain treatment over the other in the overall
and the PD reduction at 1-year post- population.
surgery were respectively 4.171.8 and  PAL baseline values and INFRA
5.371.9 mm. The group of patients components play an important role
treated with membranes showed an in treatment response, with a marked
tendency of PAL gain to be higher in
Table 2. Distribution of patients between patients with high PAL 0 and/or high
treatment and clinical center INFRA.
 Our analysis suggests that PAL base-
Center Subject Subject
treatment: GTR treatment: EMD line values influence PAL gain in a
different way for the two regenerative
1 8 8 procedures. More specifically, our
2 8 6 data suggest that in subjects with
3 6 5 PAL 0 48 mm, GTR yields on
4 10 12 average a better clinical outcome in
5 7 7
6 10 11
terms of PAL gain when compared
with Emdogains. To confirm this
finding, we reapplied the model of
regression analysis to the subset of
Table 3. PAL gain and PD reduction for the our patients with PAL 0 48 mm, in
two groups 1 year postop which GTR was more effective than
the Emdogains procedure within the
PAL gain PD var
subpopulation of patients with PAL 0
GTR 4.371.9 5.671.5 48 mm. Within this subset of pa-
EMD 4.171.8 5.371.9 tients, PAL 360 after GTR treatment
p NS NS appears on average to be 0.86 times
smaller than after Emdogains treat-
ment. In patients with PAL 0
48 mm, the average PAL gain
among GTR patients was 0.3 mm
higher than among Emdogains sub-
PD 0 REC 0 INFRA
jects. These results are illustrated by
8.171.9 1.171.0 6.171.7 the plot in Fig. 1, where the vertical
8.571.6 1.871.9 6.472.5 axis represents therapeutic gain ex-
NS NS NS pressed as 100% (lower values re-
presenting better outcomes), and the
horizontal axis represents PAL 0
values. The dependence of PAL 360
on PAL 0 appears to be striking in the
390 Silvestri et al.
Fig. 1. Scatterplot: The baseline values of PAL are indicated on the horizontal axis, while
the PAL gain is expressed as a percentage on the vertical axis; i.e. the case treated with GTR
that presented a PAL of 10 mm at baseline, PAL gain of 80% with a residual PAL of 20% at
1 year.
GTR group, with a more favorable
clinical outcome in patients with high
PAL at baseline. Clinical outcome
in Emdogains patients does not
appear to be particularly sensitive
to PAL 0. A possible biological
interpretation of this finding is
given in the Discussion section.
Among patients with a high value of
PAL 0, those undergoing GTR appear
on average to achieve greater gains
than those undergoing Emdogains.
This becomes evident only if we
focus on patients well above PAL 0
48.
 The statistical model shows a statis-
tically significant correlation between
the percent of PAL gain and the
bleeding score (p 5 0.031) for both
treatments, indicating a better clinical
outcome for those cases in which the
bleeding score is lower.
 The set of patients was stratified into
three groups, each of which was
characterized by the predominant
number of walls component. The 1-
wall component was predominant in
the first group, the 2-wall component
in the second- and the 3-wall compo-
nent in the 3rd. The analysis suggests
a significant (p 5 0.002) difference in
terms of PAL gain between the group
with the three-wall component and
each of the other two groups. Statis-
tically significant differences were
not observed between the one- and
two-wall groups.
Discussion
The study design of this multicenter
controlled clinical trial was based on a
previous study (Silvestri et al. 2000) in
which three groups of patients were
treated with Widman modified flap
(MWF), ePTFE membranes and enamel
matrix protein respectively. The statis-
tical analysis, in agreement with pre-
vious clinical trials (Heijl et al. 1997,
Pontoriero et al. 1999), showed a highly
significant difference in terms of PAL
gain between the group treated with
MWF and the other two groups (GTR
and EMD). For this reason, the multi-
center controlled clinical trial did not
consider the MWF and focused atten-
tion on the comparison of EMD and
ePTFE treatments.
As previously demonstrated in the
pilot study, and in agreement with other
authors (Pontoriero et al. 1999, Sculean
et al. 2001), the results of this multi-
center controlled clinical trial confirm
that there are no statistically significant
differences in terms of PAL gain and
PD reduction between EMD and ePTFE
groups (Table 2). The regression analy-
sis compares data in terms of percent of
PAL gain and percent of PD reduction
(Figs. 1 and 3). PAL gain values at 1
year after surgery are shown in Figs. 1
and 2. In Fig. 1, PAL baseline values are
indicated on the horizontal axis while
PAL gain, at 1 year postop, is expressed
on the vertical axis as a percentage and
the lower values represent better out-
comes; i.e. if a case on the vertical axis
shows a value of 40%, it means that the
PAL gain is 60%. The slope of the two
plotted lines shows a different clinical
outcome of PAL gain at 1 year postop,
for the two treatments. In particular, in
those subjects in whom the PAL 0 was
>8 mm, GTR treatment demonstrated a
statistically significant better clinical
outcome with respect to EMD, again
confirming the results observed in the
pilot study (Silvestri et al. 2000).
However, the PAL gain variation be-
tween the two treatments was just
0.3 mm, a variation with a very low
impact from a clinical point of view. As
hypothesized in the previous pilot study,
this could be due to the fact that we
observed a high rate of membrane
exposure (48%). Bacterial colonization
starts from membrane exposure, leaving
a complete potential regeneration in the
most apical part of the lesion. There-
fore, bacterial colonization of the newly
formed tissue in a less deep defect may
cause a much more significant loss of
regeneration potential compared with
those lesions where very deep defects
are present. In the present study, we
observed a lower rate of membrane
exposure compared to the pilot study,
48% versus 70%, and this can be
explained by the fact that we altered
the surgical approach by introducing the
papilla preservation technique. This
type of soft tissue management may
have a stronger impact in subjects
treated with GTR procedures precisely
because it is there that we observed a
reduction in membrane exposure. On
the contrary, there was no evidence of a
significant clinical improvement in the
patients treated with EMD procedures,
because even in the previous study we
did not find any flap dehiscence.
Comparing the slopes of the two
plotted lines with those observed in the
pilot, it seems that a rotation of both
lines in an anticlockwise direction
occurs. In terms of clinical outcome,
this means that for cases with PAL 0
>8 mm, the PAL gain is slightly lower
in both groups with respect to our
previous study. Conversely, the PAL
gain appears to be higher in cases with
 Periodontal regeneration with EMD 391

PAL 0 o8 mm. Although there is no

statistical support to sustain these affir-
mations, we have tried to explain the
above-cited rotation taking into account
the following facts:

 The clinical outcomes derived from

this trial are based on a larger number
of patients compared to the previous
study.
 Unlike the pilot study, this is a
multicenter trial in which center
variability must be considered. De-
spite the fact that a calibration meet-
ing was held, one cannot completely
discount inevitable differences in
patient population, center organiza-
tion and the technical ability of
clinicians.
 The surgical technique performed in
this study was changed and thus a
new variable was introduced into the
protocol. Fig. 2. Scatterplot: The PAL gain is expressed as a percentage on the vertical axis, while the
horizontal axis indicates the values of infrabony component measured at surgery: the lower
values on the vertical axis represent the better outcomes as explained in the legend of Fig. 1.
As mentioned above, we used the
technique suggested by Takei et al.
(papilla preservation technique) or that
modified by Cortellini et al., depending
on the anatomy of the infrabony defect.
The choice between one and the other
technique was made so as to place the
papilla incision directly over the bone
and as far as possible from the deepest
component of the defect. The efficacy of
this surgical approach will need further
investigation to evaluate its true clinical
worth.
Fig. 2 reports the correlation between
the PAL gain at 1-year postop, ex-
pressed as percent on the vertical axis,
and the values of infrabony component,
measured at surgery, reported on the
horizontal axis. The behavior pattern of
the two lines is very similar to that
observed in Fig. 1, where the correlation
between PAL baseline values and PAL
gain at one year postop is indicated. The
reason for this similarity could be the
strong correlation between the PAL
baseline values, reported in Fig. 1, and Fig. 3. Scatterplot: The PD changes for the two groups are indicated. Baseline values are
the infrabony component reported on shown on the horizontal axis, while PD reduction is reported on the vertical axis. The lower
the horizontal axis in Fig. 2. values on the vertical axis represent the better outcomes as explained in the legend of Fig. 1.
Fig. 3 indicates the PD changes for
the two groups. Baseline values are
shown on the horizontal axis, while terms of PD reduction (p>0.05) for the bleeding score is lower (Table 2). This
percentages of PD reduction are re- two treatments. result suggests that within a group of
ported on the vertical axis. Therefore, if The linear regression model shows a patients with FMBS o25%, the border
the PD value is 0 on the vertical axis, statistically significant correlation be- line value to obtain predictable period-
this means that PD reduction is 100%. tween the percent of PAL gain and the ontal regeneration (Tonetti et al. 1993),
The two lines remain almost parallel bleeding score (p 5 0.031) for both subjects with a lower bleeding index
and appear to be quite close to each treatments, indicating a better clinical showed a better clinical response in
other, demonstrating similar results in outcome for those cases in which the terms of PAL gain. This fact seems to
392 Silvestri et al.
suggest that the limit of 25% for the
FMBS to have a predictable periodontal
regeneration could be lower than 25%.
Another parameter that has been
shown to influence the clinical outcome
at 1 year was the percentage wall
component of the defect. The analysis
suggests a significant (p 5 0.002) dif-
ference in terms of PAL gain between
the group in which the three-wall
component was predominant and each
of the other two groups. It did not
observe statistically significant differ-
ences between the one- and two-wall
groups. From a clinical point of view,
this fact seems to suggest that the blood
clot protection is better in defects with a
predominant three-wall component. The
goal of the regenerative procedure is to
obtain a gain of periodontal destroyed
tissues as much as possible without
compromising esthetics and, in particu-
lar, the gingival and papillary profile.
We have to consider that a GTR
procedure can be subjected to mem-
brane exposure (Cortellini et al. 1995b)
and loss of the height of the papilla.
Moreover, these events could have a
higher incidence in cases where the
embrasure space is narrow and the
papilla does not have a great thickness
(Cortellini et al. 1995b). For this reason,
we suggest treating these kinds of cases,
particularly in esthetic areas, with the
EMD procedure. Conversely, the GTR
procedure appears to be preferable in
cases where the esthetic component has
secondary importance and, in accor-
dance with the results of the covariance
analysis, when the defect is much
deeper.
Acknowledgments
We express our gratitude to Professor
Carlo Berzuini of Systemistic and
Statistic Department, University of Pa-
via, for the data analysis and statistic
elaboration. Our gratitude also goes to
Dr. Egon Ewue of the University of
Milan for his effort in the development
of this study.
Zusammenfassung
Vergleich von mit Schmelzmatrixderivaten be-
handelten intraalveolären Defekten mit Defek-
ten, die mit nicht resorbierbaren Membranen
mit der GTR behandelt wurden. Eine kontrol-
lierte klinische Multicenterstudie
Ziel: Der Zweck der vorliegenden klinischen
Multicenterstudie war der Vergleich der Effek-
tivität von zwei unterschiedlichen Prozeduren
in der Behandlung von intraalveolären Defek-
ten: gesteuerte Geweberegeneration (GTR) mit
nicht resorbierbaren Membranen und Schmelz-
Matrix-Derivaten (EMD).
Material und Methoden: Sechs Zentren nah-
men an der Studie teil. 98 Patienten mit
approximalen intraalveolären Defekten wurden
ausgesucht. Alle Patienten wurden in der
initialen Phase mit Wurzelreinigung und –
glättung behandelt, und zur Basis der Studie
zeigten die ausgewählten Defekte Sondierung-
stiefen von 6 mm mit einem intraalveolären
Anteil von X4 mm. 49 Patienten wurden mit
dem GTR Verfahren (unter Nutzung einer e-
PTFE Membran1) und 49 Patienten mit den
Schmelz-Matrix-Derivaten (Emdogains2) be-
handelt. Die Effektivität von jeder Behan-
dlungsvariante wurde mit der Kovarianzanalyse
untersucht.
Ergebnisse: Die Patienten wurden 1 Jahr nach
der Operation reevaluiert. Die Veränderungen
des Stützgewebeniveaus (PAL) und die Reduk-
tion der Sondierungstiefen (PD) wurden analy-
siert. In der Emdogains Gruppe betrugen die
PAL (PAL 0) und die PD (PD 0) vor der
Chirurgie 9,971,4 mm und 8,571,6 mm. Der
PAL Gewinn und die PD Verringerung nach
einem Jahr postoperativ waren 4,171,8 mm
und 5,371,9 mm. Die Gruppe der Patienten,
die mit Membranen behandelt worden waren,
zeigten Werte von PAL 0 und PD 0 von
8,971,9 mm und 8,171,9 mm. Der PAL
Gewinn betrug 4,371,9 mm und die PD
Reduktion 5,671,5 mm. Der mittlere PAL
Gewinn in Prozent (PAL Gewinn/PAL 0) für
die EMD-Gruppe war 41%, während er für die
GTR-Gruppe 48 % betrug.
Die Ergebnisse unserer Analyse zeigen, dass
keine statistisch signifikante Differenz zischen
GTR und EMD Behandlungen in Bezug auf
PAL Gewinn, PD Reduktion und REC Ver-
änderung bestand.
Unter Nutzung der Regressionsanalyse für eine
Gruppe mit PAL 0 X8 mm beobachteten wir
ein besseres klinisches Ergebnis bezüglich des
PAL Gewinns (Differenz 0,3 mm) bei GTR-
Patienten verglichen mit EMD-Patienten.
Die Kovarianzanalyse zeigte eine starke Korre-
lation in beiden Patientengruppen zwischen
PAL Gewinn und dem vollständigen Blutung-
sindex (FMBS) sowie zwischen PAL Gewinn
und Morphologie und Tiefe des Defektes.
Résumé
Comparaison entre les le´sions intraosseuses
traite´es par les de´rive´s de la matrice ame´laire
vs la re´ge´ne´ration tissulaire guide´e avec une
membrane non-re´sorbable. Un essai clinique
contrôle´ et multicentrique
Le but de cet essai clinique multicentrique a été
de comparer l’efficacité de deux processus
différents dans le traitement des lésions in-
traosseuses : la régénération tissulaire guidée
(GTR) avec des membranes non-résorbables et
les dérivés de la matrice amélaire (EMD). Six
centres ont participé à cette étude. Nonante-huit
1
Gore-Tex W.L. Gore and Associates, Flagstaff,
AZ.
2
Û Biora AB Malm, Sweden.
patients avec une lésion intraosseuse interprox-
imale ont été sélectionnés. Tous ont été traités
par une phase initiale de détartrage et surfaçage,
et au début de l’étude les lésons sélectionnées
avaient une profondeur de poche de 6 mm (PD)
avec un composant infraosseux X4 mm.
Quarante-neuf patients ont été traités par GTR
en utilisant une membrane en téflon et 49 par
EMD (Emdogains2). L’efficacité de chaque
traitement a été étudiée par l’analyse de co-
variance. Les patients ont été réévalués un an
après l’opération. Le gain du niveau d’attache
au sondage (PAL) et la réduction de PD ont été
analysés. Dans le groupe EMD, le PAL et le PD
présents avant la chirurgie, (PAL 0) et (PD 0),
étaient respectivement de 9,971,4 mm et de
8,571,6 mm. Le gain PAL et la réduction de
PD après une année étaient respectivement de
4,171,8 mm et 5,371,9 mm. Le groupe de
patients traités avec les membranes accusaient
un PAL 0 et un PD 0 qui étaient respectivement
de 8,971,9 mm et de 8,171,9 mm. Le gain
PAL était de 4,371,9 mm après une année
tandis que la réduction PD était de 5,671,5
mm. Le gain PAL moyen exprimé en pourcen-
tage (gain PAL/PAL 0) pour le groupe traité
avec EMD était de 41% tandis qu’il était de 48
% dans le groupe traité par GTR. Les résultats
de cette analyse suggèrent qu’il n’y a aucune
différence statistique entre les traitements GTR
et EMD en terme de gain PAL, de réduction PD
et dans le changement de récession. Lors de
l’utilisation du modèle de régression sur un
groupe de patients avec un PAL 0 X8 mm, une
guérison clinique supérieure était observée dans
le gain PAL (différence de 0,3 mm) chez les
patients traités avec GTR comparés à ceux
traités par EMD. L’analyse de co-variance
montrait une relation importante dans les deux
groupes de patients entre le gain PAL et le score
de saignement de l’ensemble de la bouche, et
entre le gain PAL et la morphologie de la lésion
et sa profondeur.
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Address:
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