J Clin Periodontol 2013; 40: 8289 doi: 10.1111/jcpe.

12019

Treatment of gingival recession

defects with a coronally
advanced flap and a xenogeneic
collagen matrix: a multicenter
randomized clinical trial

Karin Jepsen1, Sren Jepsen1, Giovanni Zucchelli2, Martina Stefanini2,

Massimo de Sanctis3, Nicola Baldini3,
Bjorn Greven4, Bernd Heinz4, Jan
Wennstrom5, Bjorn Cassel5, Fabio
Vignoletti6 and Mariano Sanz6
1

Department of Periodontology, University of

Bonn, Bonn, Germany; 2Department of
Stomatology, Bologna University, Bologna,
Italy; 3Department of Periodontology, Siena
University, Siena, Italy; 4Private Practice,
Hamburg, Germany; 5Department of
Periodontology, University of Goteborg,
Goteborg, Sweden; 6Department of
Periodontology, University of Madrid, Madrid,
Spain

Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B,

Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival
recession defects with a coronally advanced flap and a xenogeneic collagen matrix:
a multicenter randomized clinical trial. J Clin Periodontol 2013; 40: 8289. doi:
10.1111/jcpe.12019.

Abstract
Aim: To evaluate the clinical outcomes of the use of a xenogeneic collagen matrix
(CM) in combination with the coronally advanced flap (CAF) in the treatment of
localized recession defects.
Material & Methods: In a multicentre single-blinded, randomized, controlled,
split-mouth trial, 90 recessions (Miller I, II) in 45 patients received either
CAF + CM or CAF alone.
Results: At 6 months, root coverage (primary outcome) was 75.29% for test
and 72.66% for control defects (p = 0.169), with 36% of test and 31% of control defects exhibiting complete coverage. The increase in mean width of keratinized tissue (KT) was higher in test (from 1.97 to 2.90 mm) than in control
defects (from 2.00 to 2.57 mm) (p = 0.036). Likewise, test sites had more gain in
gingival thickness (GT) (0.59 mm) than control sites (0.34 mm) (p = 0.003).
Larger (  3 mm) recessions (n = 35 patients) treated with CM showed higher
root coverage (72.03% versus 66.16%, p = 0.043), as well as more gain in KT
and GT.
Conclusions: CAF + CM was not superior with regard to root coverage, but
enhanced gingival thickness and width of keratinized tissue when compared with
CAF alone. For the coverage of larger defects, CAF + CM was more effective.

Conflict of interest and source of

funding statement
The authors declare that they have no
conflict of interest. This study was
supported by a research grant from
Geistlich Pharma AG.

82

Several surgical techniques and flap

designs have been utilized to correct
gingival recession defects by augmenting gingival tissue dimensions
and hence, covering the exposed root
surfaces (Pini-Prato et al. 1995). Procedures using pedicle flaps, free soft
tissue grafts, combination of pedicle

Key words: collagen (matrix); gingival

recession; keratinized tissue; root coverage;
tissue regeneration; xenograft
Accepted for publication 2 September 2012

flaps with grafts, barrier membranes

or enamel matrix derivative are all
effective for this purpose as attested
by many studies (Cairo et al. 2008).
More specifically, it was demonstrated that localized gingival recessions can be successfully treated with
a coronally advanced flap (CAF),
2012 John Wiley & Sons A/S

Multicenter RCT of collagen matrix and CAF for root coverage

although the additional use of a connective tissue graft (CTG) or other
biomaterials has shown to improve
mean root coverage and the predictability of complete root coverage,
when compared with CAF alone
(Cairo et al. 2008, Cortellini et al.
2009). A recent Cochrane systematic
review (Chambrone et al. 2010) concluded that the subepithelial CTG
procedure, the CAFs alone or associated with other biomaterials may
render good results, although in
cases where root coverage and gain
in keratinized tissue are expected,
the use of CTG seems to be more
adequate. However, the wound at
the palatal donor site for harvesting
the CTG is frequently associated
with discomfort for the patient
(Cairo et al. 2008, Chambrone et al.
2010).
To reduce patient discomfort,
swelling and sometimes pain associated with the wound at the palatal
donor site when harvesting the
CTG, alternatives are needed.
A newly developed xenogeneic collagen matrix (CM) has been shown to
promote regeneration of keratinized
gingiva around teeth and implants
in association with tissue augmentation procedures (Sanz et al. 2009)
and to improve early mucosal
wound healing (Thoma et al. 2012).
McGuire & Scheyer (2010) studied
the safety and efficacy of this
CM + CAF for recession therapy in
25 patients with bilateral Miller
I and II recessions in a mono-centre,
randomized,
single-blind,
splitmouth designed trial. Although values
of
root
coverage
for
CAF + CTG (99.3%) were higher
than for CAF + CM (88.5%), they
found the procedure to be less
invasive and time consuming with
unlimited off-the-shelf supply of
grafting material, and concluded
that it presents a viable alternative
to the CTG procedure.
There are, however, no data
available on the possible added benefit of the use of this CM in combination with CAF when compared to
the standard CAF procedure for the
treatment of localized gingival recessions. It was, therefore, the primary
objective of this randomized clinical
trial to evaluate the effect of CM in
combination with CAF treatment
compared to CAF alone with respect
to root coverage. As secondary
2012 John Wiley & Sons A/S

83

objectives, the amount of soft tissue

augmentation and patient-centred
outcomes were evaluated.

Material and methods

After a thorough explanation of

the study procedures and their associated risks and benefits, participants
signed an informed consent in accordance with the Helsinki Declaration
of 1975 as revised in 2000. The study
protocol
had
been
previously
approved by the respective ethical
committees for human subject trials
from the centres participating in the
study. All female patients confirmed
not to be pregnant and agreed for
contraception measures for at least
6 months after surgery.

Study design and patients

This investigation was designed as a

multicentre multinational, singleblind,
split-mouth
randomized
clinical trial (Fig. 1). The study protocol was registered with ClinicalTrials.gov, Registration number:
NCT00902876. A total of 45 patients
were consecutively selected to participate in the study from six different
clinics in Germany, Italy, Sweden
and Spain and were treated with
both experimental and control surgical procedures by expert periodontists. These patients were selected
according to the following inclusion
criteria:

Presence of at least one localized

gingival recession in each side of
the maxilla and/or mandible.
The cementoenamel junction
(CEJ) was visible in the teeth for
root coverage procedures.
All recessions were Class I or II
defects (Miller 1985).
The two defects within one
patient did not deviate more than
2 mm in recession depth.
All patients demonstrated adequate plaque control with a fullmouth plaque score  20% and
with no clinical signs of active
periodontal disease.
All patients were at least 18 years
of age.
The criteria for exclusion were:

Patients smoking more than 10

cigarettes per day.
Patients with insulin-dependent
diabetes.
Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
Patient pregnant or nursing during the past 5 months.
Patients taking medications or
having treatments with an effect
on mucosal healing in general
(e.g. steroids, large doses of antiinflammatory drugs).
Patients with a disease affecting
connective tissue metabolism.
Patients allergic to collagen.

Patients who participated in a

clinical trial within the past
6 months.

Clinical measurements

The primary endpoint of this trial

was the percentage of root coverage
(RC) at 6 months. Secondary endpoints were reductions in recession
depth (REC), recession width (RW),
complete root coverage (CRC), gain
in thickness of gingival tissue (GT),
gain in clinical attachment and
increase in width of keratinized tissue (KT).
At
baseline,
3-month
and
6-month visits, one single-blinded
examiner per study site, different
from the surgical operator, recorded
all the clinical outcome variables.
The following parameters were
assessed in millimetres with the use
of a University of North Carolina
periodontal probe (Hu-Friedy, Chicago, IL, USA):

REC from the free gingival margin to the cementoenamel junction.

RW at the cementoenamel junction.
KT from the free gingival margin
to the mucogingival junction.
GT with an injection needle
(Sopira Carpule 0.3 9 16 mm,
Heraeus Kulzer) and a silicon
marker, 1 mm below the gingival
margin.

Pre-operative (Fig. 2) and followup photographs were taken at each

visit. For patient-related factors, a
questionnaire as well as a visual
analogue scale (VAS) were given to
the patients to assess pain and discomfort during the initial healing
phase.

84

Jepsen et al.
Enrollment

Assessed for eligibility (n = 77)

Not meeting inclusion criteria (n = 18 )

Declined to participate (n = 12)
Other reasons (n = 2)

Randomized (n = 45)

Allocation
Allocated to intervention (n = 45 sites )
Received allocated intervention (n = 45)

Allocated to intervention (n = 45 sites)

Received allocated intervention (n = 45)

Did not receive allocated intervention (n = 0)

Did not receive allocated intervention (n = 0)

Follow-Up
Lost to follow-up (n = 0)

Lost to follow-up (n = 0)

Discontinued intervention (n = 0)

Discontinued intervention (n = 0)

Analysis
Analysed (n = 45 sites)
Excluded from analysis (n = 0)

Analysed (n = 45 sites)
Excluded from analysis (n = 0)

Fig. 1. Consort flow diagram of the study.

they were provided with customized

oral hygiene instructions, including
control of traumatic tooth brushing
techniques as well as a dental prophylaxis and polishing.
Randomization, allocation concealment and blinding

Fig. 2. Baseline. Gingival recessions on right and left canine scheduled to undergo
coronally advanced flap procedures.
Selection of clinical centres and training
of investigators

Twelve expert periodontists in different clinical centres who were experienced operators in mucogingival
surgery were selected to participate
in the study. All participating investigators were required to attend
training and calibration meetings to
review the objectives of the study
and the protocol. Organizational
strategies were discussed to optimize
patient accrual and retention and
data management. Preliminary clinical cases were discussed to standardize case selection, the measurement
techniques and the surgical procedures. Prior to starting the study,

each operator was video trained on

the surgical procedure in detail.
An external monitor frequently
reassured on-site rules for the compilation of the data collection sheets
for appropriate oversight to ensure
the validity of the data.
Treatment

Pre-surgical phase
As part of the screening phase for
inclusion, all patients had a fullmouth periodontal examination with
registration of probing pocket depths
(PD) and full-mouth bleeding scores
(FMBS), Once the selected patients
agreed to participate in the study,

Selected patients were randomly

assigned to treatment by a central
registrar using a computer-generated
randomization list with random permuted blocks (Fig. 1). The treatment
allocation was concealed to the therapist by opaque envelopes that were
opened upon completion of the common part of the surgical treatment
(flap elevation and root conditioning). The clinical examiners remained
blinded to the treatment assignment.
Blinding was broken after completion of the statistical analysis.
Surgical procedures
The coronally advanced procedure
(CAF) as described by De Sanctis &
Zucchelli (2007) was used in this
investigation for both experimental
and control sites (see Data S1), only
the order of sutures was reversed.
The exposed root surfaces were
conditioned with 24% EDTA for
2 min. to remove the smear layer
2012 John Wiley & Sons A/S

Multicenter RCT of collagen matrix and CAF for root coverage

from the dentine tubules (Blomlof
et al. 1997) and thus improve coagulum adhesion to the root surface
(Gamal 2011). After EDTA application, the root surface was rinsed
with saline for 60 s.
Following treatment allocation,
the test material was applied in the
test sites. This material consisted of
a three-dimensional collagen matrix
(Mucograft; Geistlich Pharma AG,
Wolhusen, Switzerland).
The collagen matrix was cut to
the size of the experimental defect,
allowing a slight overlap and placed
on the prepared recipient bed with
the smooth surface facing the oral
cavity and the porous surface facing
the bone. Sharp edges were removed
and the matrix was fixed to the root
surface with resorbable sling sutures
(Vicryl 6-0, V492, P-3; Ethicon Inc.,
Johnsson & Johnsson, NJ, USA).
Complete moistening by blood and
exudates allowed perfect adhesion of
the matrix.
Subsequently, in both treatment
sites, the root surface was covered
with the coronally advanced flap and
secured with sutures slightly coronally
of the CEJ by means of a sling
suture placed at the adjacent papillae, using non-irritating sutures (Prolene 6-0, 8697, P-1; Ethicon Inc.).
The vertical incisions were then
closed by means of interrupted
periosteal 6-0 sutures starting at the
most apical extension of the vertical
release incisions. No periodontal
dressing was applied.
Post-surgical protocol
Following surgery, patients were
instructed to rinse twice daily with
chlorhexidine mouth rinse (0.2%)
for 1 month. Patients were instructed
to avoid any mechanical trauma and
tooth brushing for 4 weeks in the
surgical area. Anti-inflammatory
therapy and additional analgesics
were prescribed according to the
individual needs and the patient
was instructed to record daily the
intensity of pain and the dose of
medication in the patient questionnaire.
The lateral sutures were removed
after 7 days if possible, and the sling
suture was removed after 14 days.
Clinical photographs were taken
after cleaning and polishing to document the healing process (Fig. 3).
Patients were recalled at 3 and
2012 John Wiley & Sons A/S

6 months after surgery for professional oral hygiene procedures.

and dropouts,
recruited.

45

patients

85
were

Data analysis

The study was conducted under international quality standards (ISO14155)

and the applicable national laws
to avoid bias including clinical
monitoring, data management, GCP
audits and statistical analysis.
The main hypothesis was that
CAF combined with the xenogeneic
collagen matrix would result in
improved outcomes (superiority trial)
(Cairo et al. 2012a, Tonetti &
Palmer 2012) in terms of percentage
of root coverage when compared
with CAF alone was tested by onesided paired Wilcoxon signed rank
test at the 5% level of significance
(Sackett 2004). This procedure was
further used for an exploratory comparison of the treatments with
respect to other endpoints. Paired
differences were tested using Wilcoxons signed rank tests for paired
samples.
For differences in primary outcomes of maxillary and mandibular
defects, a two-sided MannWhitney
U-test was performed.
To determine the association
between the primary end point percentage of root coverage and baseline recession depth, Pearsons and
Spearmans correlation coefficients
were calculated for test and control
sites separately.
Possible differences in the primary outcome between study centres
were explored by the KruskalWallis
test.
The analysis was performed using
SAS version 9.2 (SAS Institute Inc.,
Cary, NC, USA).
Sample size calculation
The calculation of patients to be
treated was based on the primary
objective to detect a true mean difference of at least 10 percentage
points between test and control
treatment for root coverage after
6 months (McGuire & Scheyer
2010). With a power of 80% and
alpha = 0.05, based on superiority
considerations, a total of 35 patients
were required using a one-sided ttest for paired samples. The standard
deviation of the differences was
assumed to be 23 percentage points.
To allow for non-parametric testing

Results

Forty-five patients (mean age:

39.5 13.8 years, 2073 years, 17
men, 28 women) were recruited and
treated between 2009 (February) and
2010 (December). The number of
patients per centre ranged from 3 to
11. All patients were able to complete
the follow-up examination after
6 months.
Study teeth were maxillary central incisors (2), canines (40), premolars (24) and first molars (4) as
well as mandibular incisors (2),
canines (4) and pre-molars (14),
yielding 35 pairs of defects in the
maxilla and 10 pairs in the mandible.
Surgeries and post-operative sequelae were uneventful and no patient
in any group developed any significant complication.
Table 1 depicts the descriptive
statistics for all clinical parameters.
Contra-lateral test and control
defects were well balanced at baseline. The results for the primary and
secondary clinical outcomes are presented in Table 2. At 6 months, the
primary end point percentage of root
coverage was on average 75.29% for
test sites and 72.66% for control
sites (p = 0.1695). For the secondary
outcomes, the following results were
obtained: Mean recession depth at
6 months was decreased to 0.87 mm
for test sites and 1.02 mm for control sites. The split-mouth design of
the study allowed calculation of
intra-patient differences (change for
test minus change for control),
which translated to a significant
mean difference of 0.27 mm in recession depth changes from baseline to
6 months (p = 0.0175) in favour of
the test treatment. In contrast, for
the reductions in recession width, no
significant differences between treatments were observed (p = 0.3925).
At 6 months, 36% of test defects
and 31% of control defects showed
complete root coverage.
The width of keratinized tissue
could be increased on average from
1.97 to 2.90 mm for test sites and
from 2.00 to 2.57 mm at control
sites. The difference in gain of
0.37 mm was significant (p = 0.036).
Likewise, for test defects, there was

86

Jepsen et al.

a significantly higher increase in the

thickness of gingival tissue (0.24 mm,
p = 0.0035).
For the test treatment, no linear
relation could be found between
baseline recession depth and the primary outcome % recession coverage
at 6 months (Fig. 4). This was in
contrast to the control treatment,
where a negative linear relationship
may be claimed (Pearsons correlation coefficient: 0.4193, p = 0.0041,
Spearmans correlation coefficient:
0.509, p = 0.0004) between baseline
recession and the primary outcome
with 95% confidence (Fig. 5). Following CAF treatment, shallow
defects had a higher percentage of
recession coverage than deeper
defects.
No significant centre effect with
regard to the primary outcome could
be determined (KruskallWallis,
p = 0.2450).
In a further analysis, patients
with shallow defects (REC < 3 mm)
were excluded (Tables 3 and 4). For
the remaining 35 patients, at
6 months root coverage was higher
for test (72.03%) than for control
sites (66.16%) (p = 0.0430). More
keratinized tissue was gained by test
treatment (0.54 mm, p = 0.0055).
Likewise, for test defects, there was

a significantly higher increase in the

thickness
of
gingival
tissue
(0.31 mm, p = 0.0030).
When comparing test and control
treatments, patient assessments of
pain or discomfort were equivalent
(Table. 5). No differences could be
observed in visual analogue pain
scores at 7 days (2.32 versus 2.04)
and 14 days (0.68 versus 0.59) post
surgery (Table. 6). The overall surgical chair time for CAF was
31 14 min. versus 39 14 min. for
CAF + CM.
Discussion

To the best of our knowledge, this is

the first randomized clinical trial
designed to evaluate the additional
benefit of the use of a xenogeneic
collagen matrix in combination with
the CAF procedure for the treatment
of localized gingival recessions, when
compared with CAF alone. As the
primary outcome for efficacy, we
measured the % of root coverage at
6 months, resulting in the test group
(CAF + CM) in a higher % RC of
75.29% versus 72.66% in the control
group (CAF). This difference, however, was not significant. Hence, the
hypothesis of an enhanced outcome
by the use of the CM could not be

Fig. 3. Six-month follow-up. Coronally advanced flap (CAF) + xenogeneic collagen

matrix (CM) and CAF alone were performed and complete root coverage was
achieved at treated teeth. Tooth 13 received CAF + CM.

confirmed. However, the use of the

CM resulted in significantly more
gain in gingival thickness and width
of keratinized tissue.
The use of a xenogeneic collagen
matrix as an adjunct to the CAF
procedure might be relevant for
several reasons; first because the
CAF surgical procedure has demonstrated very good results in the treatment of localized gingival recessions,
both in terms of root coverage as
well as in aesthetic outcomes (PiniPrato et al. 1995). The demonstrated
additional effect shown in this RCT,
therefore, may improve the predictability of this procedure in the treatment of Class I and II recession
defects. When the CAF procedure
has been compared with the adjunctive use of an auto graft, recent systematic reviews have clearly shown
the advantage of placing a connective tissue graft under the flap (Cairo
et al. 2008, Chambrone et al. 2010).
In fact, when identifying which were
the significant factors, both patient
and procedure- related, in the attainment of complete root coverage, an
individual patient data meta- analysis of randomized controlled clinical
trials showed that the adjunctive use
of a subepithelial connective tissue
graft achieved superior results than
the coronally advanced flap alone
(Chambrone et al. 2012). On the
other hand, when assessing the incidence of adverse effects, such as discomfort with or without pain, these
events were directly related to the
donor sites source of the connective
tissue grafts and a second wound
area (Cairo et al. 2008, 2012b,
Chambrone et al. 2010).
Hence, an alternative for the connective tissue graft, which renders
better results than the CAF procedure, might be a good therapeutic
option in the treatment of Class
I and II recession defects.

Table 1. Clinical parameters at baseline (BL), 3 and 6 months

Mean (SD)
BL
Recession depth (REC)
Recession width (RW)
Width of keratinized tissue (KT)
Thickness of gingival tissue (GT)
Clinical attachment level (CAL)
Probing pocket depth (PPD)

Test (CAF + CM)

Control (CAF)

3.34
4.10
2.00
0.89
4.82
1.48

(1.00)
(0.93)
(1.22)
(0.34)
(1.09)
(0.65)

3M
0.89
2.01
2.40
1.17
2.22
1.33

(1.11)
(1.72)
(0.93)
(0.46)
(1.33)
(0.60)

6M
1.02
2.27
2.57
1.23
2.21
1.19

(1.08)
(1.75)
(1.15)
(0.46)
(1.25)
(0.58)

BL
3.46
4.08
1.97
0.89
4.79
1.33

(0.90)
(0.89)
(1.13)
(0.28)
(1.01)
(0.46)

3M
0.84
1.89
2.59
1.37
2.14
1.30

(0.95)
(1.84)
(1.28)
(0.47)
(1.15)
(0.62)

6M
0.87
2.15
2.90
1.48
2.09
1.22

(0.94)
(1.86)
(1.29)
(0.46)
(1.14)
(0.67)

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Multicenter RCT of collagen matrix and CAF for root coverage

87

Table 2. Changes in clinical parameters between baseline (BL) and 3 and 6 months
Mean (SD)

% Root coverage (RC)

% Defects with 100% coverage (CRC)
Recession depth (REC) reduction
Recession width (RW) reduction
Increase in width of keratinized tissue (KT)
Increase in thickness of gingival tissue (GT)

Control (CAF)

Test (CAF + CM)

BL 3M

BL 6M

BL 3M

BL 6M

76.44 (26.83)
38
2.46 (1.06)
2.09 (1.57)
0.40 (1.04)
0.28 (0.53)

72.66 (26.19)
31
2.32 (0.99)
1.84 (1.48)
0.57 (0.98)
0.34 (0.55)

76.11 (26.81)
38
2.61 (1.09)
2.19 (1.67)
0.62 (1.12)
0.48 (0.46)

75.29 (26.68)
36
2.59 (1.11)
1.91 (1.73)
0.93 (1.15)
0.59 (0.44)

Fig. 4. Scatterplot of % Root Coverage (RC) at 6 months versus Recession Depth

(REC) at Baseline for Defects treated with coronally advanced flap (CAF) + xenogeneic collagen matrix (CM).

Fig. 5. Scatterplot of % Root Coverage (RC) at 6 months versus Recession Depth

(REC) at Baseline for Defects treated with coronally advanced flap (CAF) alone.

The collagen matrix utilized in

this clinical trial has shown clinical
efficacy for widening the width of
keratinized tissue, both around teeth
and dental implants when used in a
non-submerged healing environment
(Sanz et al. 2009). Its use has also
been reported for the treatment of
recession defects when used in a submerged environment in combination
with the CAF procedure (McGuire
& Scheyer 2010, Cardaropoli et al.
2012). McGuire & Scheyer (2010) in
2012 John Wiley & Sons A/S

a split-mouth designed clinical trial

compared the use of CM + CAF
versus the gold-standard treatment
(CAF + CTG). Although the results
in terms of aesthetic outcomes and
patient satisfaction were good in
both groups, the percentage of root
coverage was significantly superior
for the CAF + CTG procedure
(99.3% versus 88.5%). These excellent results for the CTG procedure
are, however, superior than the
mean %RC reported in systematic

Test/Control

p-value

Change
difference BL 6M
2.63 (21.19)
0.27
0.07
0.37
0.24

(0.92)
(1.54)
(1.18)
(0.63)

0.1693
0.3870
0.0175
0.3925
0.0360
0.0035

reviews, ranging from 64.7% to

97.3% and from 34.0% to 86.7%
for CAF alone (Cairo et al. 2008,
Chambrone et al. 2010). The % RC
result reported in the present clinical
trial for the CM + CAF was 75.3%,
which is within the range of the scientific evidence for the use of connective tissue grafts, although
inferior to the mentioned comparative studies (McGuire & Scheyer
2010, Cardaropoli et al. 2012).
One reason for this discrepancy
was the fact that this study was
designed as a multicentre randomized clinical trial employing six surgeons in a variety of different
settings, what might have influenced
the extent of the results, but also
highlights its external validity and
hence, the generalizability of the
results obtained. In the preparation
of the study, the examiners had been
trained, but not calibrated with
regard to an assessment of the intraand inter-examiner reproducibility of
their recordings. This is certainly a
weakness of this study and it may
only be speculated that any systematic error would have been compensated to some extent by the
split-mouth design of the study.
Interestingly though, no centre effect
on the treatment outcomes could be
statistically demonstrated.
Another factor could be the mean
baseline recession depth, which was
smaller in both studies when compared
with
this
investigation.
Although our data showed that for
CAF alone, recession coverage correlated inversely with initial recession
depth, no such correlation was seen
with the use of CAF + CM, indicating that deeper defects would benefit
more from the additional application
of CM. Indeed, when in a
subanalysis 10 patients with shallow
recessions (<3 mm) were excluded,

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Jepsen et al.

significantly better results with

regard to % RC, gain in KT and
GT were found for CAF + CM.
As alternative treatments to the
use of autogenous grafts, allogeneic
materials have also been studied for
the treatment of recession defects.
The most studied material, acellular
dermal matrix (ADM), showed in
the meta-analyses a mean % RC for
CAF + ADM between 50% and
99% (Cairo et al. 2008, Chambrone
et al. 2010). However, these studies

did not show a significant additional

benefit over CAF alone in terms of
complete root coverage, recession
reduction or KT gain. These findings
are in contrast with those obtained
in this investigation, where a higher
gain of keratinized tissue was found
when CM + CAF was compared to
CAF alone. Using CM + CAF, the
mean gain in width of keratinized
gingiva was 0.93 mm. These results
are similar to those obtained in previous studies (McGuire & Scheyer

Table 3. Clinical parameters for patients (n = 35)

(REC)  3 mm at baseline (BL) and 6 months
Mean (SD)

with

Recession depth (REC)

Recession width (RW)
Width of keratinized tissue (KT)
Thickness of gingival tissue (GT)
Clinical attachment level (CAL)
Probing pocket depth (PPD)

3.63
4.20
2.03
0.91
5.00
1.37

6M

(0.90)
(0.99)
(1.24)
(0.35)
(1.11)
(0.56)

1.27
2.79
2.54
1.27
2.53
1.26

recession

depth

Test (CAF + CM)

Control (CAF)
BL

initial

BL

(1.09)
(1.56)
(1.22)
(0.46)
(1.18)
(0.53)

3.66
4.27
2.06
0.87
4.96
1.30

6M

(0.84)
(0.82)
(1.22)
(0.28)
(0.93)
(0.47)

1.01
2.52
3.11
1.54
2.29
1.27

(0.99)
(1.82)
(1.35)
(0.48)
(1.15)
(0.68)

Table 4. Changes in clinical parameters between baseline (BL) and 6 months for patients
(n = 35) with initial recession depth (REC)  3 mm
Mean (SD)

% Root coverage (RC)

% Defects with 100%
coverage (CRC)
Recession depth (REC)
reduction
Recession width (RW)
reduction
Increase in width of
keratinized tissue (KT)
Increase in thickness of
gingival tissue (GT)

Control (CAF)

Test (CAF + CM)

BL 6M

BL 6M

Change
differences
BL 6M

p-value

66.16 (25.7)
17

72.03 (26.85)
29

5.87 (19.25)
12

0.0430
0.1445

2.36 (1.10)

2.64 (1.18)

0.29 (0.82)

0.0380

1.42 (1.31)

1.74(1.77)

0.32 (1.47)

0.1145

0.51 (1.00)

1.06 (1.22)

0.54 (1.18)

0.0055

0.36 (0.55)

0.67 (0.40)

0.31 (0.65)

0.0030

Test/Control

2010, Cardaropoli et al. 2012),

reporting a gain of 1.3 mm and
1.2 mm respectively. In one of these
studies (Cardaropoli et al. 2012), the
increase in gingival thickness was
measured, reporting a mean gain of
1.0 mm at 12 months in the CM
group, which is somewhat more than
the mean gain of 0.6 mm reported in
this study at 6 months, but significantly higher than for CAF alone.
This gingival thickness augmentation
might improve the long term predictability of this procedure, by diminishing post-surgical relapse and thus
providing longer term stability.
There is no evidence from human
histology available to demonstrate
the quality of the healing following
the application of CM. However,
results from a recent animal experiment with recession-type defects
demonstrated that the CM in conjunction with the CAF procedure
attained significantly better regenerative outcomes than the CAF procedure alone. The healing in the
CM + CAF group was characterized
by a shorter epithelial interphase
and a larger dimension of new
cementum formation (Vignoletti
et al. 2011).
Within the limitations of this
study, the following conclusions can
be drawn:

CM + CAF was not superior to

CAF in providing a consistent
reduction of the baseline recession.
The shorter chair time could indicate the use of a CAF alone
when this issue is of primary
importance for the patient.
If the therapeutic objectives are
the increase of gingival thickness
and gain of keratinized gingiva,

Table 5. Results of patient questionnaire for post-operative pain and discomfort (Question: How was the postoperative course?)
Day 7 (n = 45)
Test only

Pain
Swelling
Unable to chew
Bleeding
Other

Day 14 (n = 44)

Control
only

Tied

Test only

Control
only

Tied

1
0
0
3
4

2.2
0.0
0.0
6.7
8.9

0
2
0
3
0

0.0
4.4
0.0
6.7
0.0

44
43
45
39
41

97.8
95.6
100.0
86.7
91.1

2
1
1
0
1

4.6
2.3
2.3
0.0
2.3

2
1
1
0
0

4.6
2.3
2.3
0.0
0.0

40
42
42
44
43

90.9
95.5
95.5
100.0
97.7

Test = collagen matrix + coronally advanced flap, control = coronally advanced flap.
2012 John Wiley & Sons A/S

Multicenter RCT of collagen matrix and CAF for root coverage

Table 6. Results for pain evaluation by
visual analogue scale (VAS)
Visit

Treatment

Mean

SD

7 days

Test
Control
Test
Control

45
45
43
42

2.32
2.04
0.68
0.59

2.08
1.82
1.21
0.91

14 days

Test = collagen matrix + coronally advanced

flap, control = coronally advanced flap.

the use of CM under

should be considered.
In recession defects  3
CM + CAF
could
recession coverage and
augmentation compared
alone.

a CAF
mm, the
improve
gingival
to CAF

Acknowledgements

The authors would like to thank

Michael Mayer for his expert statistical analysis and Dr. Wolfgang
Kleimeier for excellent study monitoring.
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benefit when compared to the standard

coronally advanced flap procedure for
the treatment of recessions.
Principal findings: The combination
of a new collagen matrix with the
coronally advanced flap yielded similar recession coverage and improved
soft tissue augmentation when com-

pared to coronally advanced flap

alone.
Practical implications: A new collagen matrix can enhance the outcomes of recession therapy with a
coronally advanced flap, and may
be an option for the coverage of
larger defects.

Supporting Information

Additional Supporting Information

may be found in the online version
of this article:
Data S1. Methods.
Address:
Karin Jepsen
Dept. of Periodontology,
Operative and Preventive Dentistry
University of Bonn
Welschnonnenstr. 17, 53111 Bonn, Germany
E-mail: jepsen@uni-bonn.de