2. The ultimate goal in treatment of localized gingival
recessions (GRs) is to achieve root coverage (RC) and
optimal esthetic soft tissue appearance.
Various surgical techniques have been shown to achieve
high percentages of RC, including the coronally advanced
flap technique (CAF) alone or in combination with a
connective tissue graft (CTG).
In fact, the combination of CAF and CTG has demonstrated
increased mean RC, as well as a higher predictability in
achieving complete RC compared with CAF alone.
3. Use of autologous CTGs, however, requires a second
surgical procedure to harvest the graft from the palate,
and is often associated with increased patient morbidity.
To avoid this second surgery, substitute materials have
been developed and tested with the goal of achieving
similar clinical outcomes as the CTG.
One of these substitutes is a xenogenic collagen matrix
(CMX) of porcine origin that has been successfully used to
augment keratinized tissue (KT) and has shown promising
results in the treatment of localized GRs, although there is
a paucity of evidence from longer-term studies.
4. The aim of this follow-up study was to compare 6-
month and 3-year outcomes for RC by CAF
procedures with or without use of a collagen
matrix (CMX) in localized GRs.
5. The study was performed in six clinical centres and was designed as a
split-mouth clinical trial to compare CAF + CMX with CAF alone in 45
patients with Miller Class I and II localized GRs.
The present report is based on the 3-year data of a subgroup of 18
patients (8 males and 10 females, aged 20 to 73 years; mean age: 44 ±
15 years) treated in two of the six participating centres.
Inclusion criteria:
1) Being at least 18 years of age
2) Presence of at least one Miller Class I or II localized GR with visible
cementoenamel junction on each side of the maxilla and/or mandible
3) No deviation of >2mm in recession depth (REC) between selected
lesions within one patient.
6. Patients were excluded if they:
1) smoked >10 cigarettes per day
2) suffered from insulin-dependent diabetes or any other
disease affecting CT metabolism, or had a demonstrated
allergy to collagen
3) were pregnant or nursing during the past 5 months
4) were taking medication or receiving treatments with an
effect on mucosal healing in general (e.g. steroids, large
doses of anti-inflammatory drugs, chemotherapy, or
radiotherapy for malignancy).
7. Selected patients were randomly assigned to the test or control
interventions by using a computer-generated randomization.
Both defects were subsequently treated in the same surgical
session, with either a CAF procedure for single GRs according to
the surgical technique described by de Sanctis and Zucchelli or
with the same surgical technique with the addition of a three-
dimensional collagen matrix placed over the recession and
submerged under the advanced flap.
Optimal adhesion of the matrix was achieved when moistened by
blood and exudates from the surgical wound. Resorbable sling
sutures were used to additionally fix the matrix to the adjacent
tissues, once properly placed to cover the exposed root.
8. Clinical Measurements
Clinical measurements were performed at 6 months, 1 year and
3 years after surgery by the same masked examiner in each
centre.
Outcomes assessed were:
1. percentage of RC
2. complete root coverage (CRC)
3. Gingival recession (REC)
4. width of keratinized tissue (KT)
5. gingival tissue (GT) thickness, measured one millimeter below
the gingival margin using an injection needle# and a silicon
marker.
6. clinical attachment level (CAL)
7. probing depth (PD)
9. The analysis included 10 patients from one centre and eight
patients from the second centre.
The treated teeth included two maxillary central incisors, 16
maxillary and two mandibular canines,10 maxillary and six
mandibular premolars.
Two patients could not be reached for 3 year follow up.
10. A) Baseline. GRs on right and left canine scheduled to undergo CAF
procedures. B) 3-year follow up. CAF + CMX and CAF alone were
performed and CRC was achieved at treated teeth. upper right
canine received CAF + CMX.
11. At baseline, mean REC was 3.19 ± 0.71 mm in the CAF + CMX
sites, and 3.11 ± 0.78 mm in the CAF sites.
After 6 months and 3 years, respectively, mean REC was 0.33
mm and 0.28 mm in the CAF + CMX sites and 0.56 mm and 0.58
mm in the CAF sites.
There was a high agreement between 6-month and 3-year RC
outcomes for both CAF Procedures. Mean RC after CAF + CMX
amounted to 89.9% after 6 months, and 91.7% after 3 years.
Mean RC at 3 years for CAF + CMX was significantly higher than
for CAF (P = 0.0039).
12. KT width was increased by 1.92 mm in the CAF + CMX
sites, and by 1.03 mm in the CAF sites after 3 years.
Mean gain in GT thickness of 0.59 mm was higher in the
CAF + CMX than in the CAF group (0.16 mm), with only
minimal changes between 6 months and 3 years.
VAS assessments for overall patient satisfaction were
generally high with nearly identical mean values of 9.75 ±
0.49 for the CAF + CMX group and 9.57 ± 0.63 for the
CAF group.
13. In the present 3-year follow-up of a randomized clinical
trial (RCT) there was a high correlation between 6-month
and 3-year outcomes for RC for both CAF procedures.
No clinically meaningful changes took place between the
6-month and 3-year evaluation, indicating the stability of
RC outcomes.
These data suggest that individual 6-month outcomes
may be useful to predict individual long-term outcomes in
CAF procedures with or without additional use of CMX.
14. Another material alternative to the use of autogenous grafts,
with available long-term data is acellular dermal matrix (ADM).
Harris evaluated CAF + ADM versus CAF + CTG retrospectively
after 3 years and reported 66% RC and 40% CRC for CAF + ADM.
He found a statistically significant loss in recession coverage for
CAF + ADM and concluded that the results with ADM tended to
break down long term whereas CTG-treated sites were more
likely to remain stable.
The 3-year results of the present study, with no significant
changes between 6 months and 3 years for CAF + CMX, are in
contrast to those for CAF + ADM where only eight out of 25
patients (32%) remained Stable.
15. It is an interesting observation that results of the present 3-year
follow-up study are somewhat different compared with those of
the original RCT including 45 patients, where RC at 6 months
was 75.3% ± 26.7% in the CAF + CMX, and 72.6% ± 26.2% in the
CAF treated sites, showing no significant difference.
However, in larger recessions RC was significantly higher in
CMX-treated sites than in sites treated with CAF alone.
In the present 3-year follow-up a significantly better outcome
for RC and CRC was found for CAF + CMX. Interestingly, this
difference was not a result of a long-term healing effect, but was
already apparent at 6 months.
16. One limitation of the present study is the fact that only two out of the
six original centres participating in the multicenter RCT were able to
follow up their patients over the 3-year period.
Nevertheless, 40% (18) of the original 45 patients could be evaluated
after 3 years. This may limit the generalizability of the present results to
some extent.
However, a power calculation confirmed that the sample size of the
present 3-year follow up had 92% power to detect a 10% difference in RC
between both groups.
Also it should be noted that most other long-term evaluations also had
a limited sample size. It always difficult to retain patients in clinical trials
for an extended period of time.
17. Within the limitations of the study the following conclusions can
be drawn
1. for both CAF and CAF + CMX, RC obtained after 6 months
remained stable over 3 years
2. CAF + CMX showed improved RC compared with CAF alone
3. CAF + CMX achieved more gain in GT thickness and increase
in KT width than CAF alone
4. both CAF and CAF + CMX provided equally successful patient-
reported outcomes.