Trial Outcomes & Findings for Comparison of Two Flaps for Root Coverage (NCT NCT02814279)
NCT ID: NCT02814279
Last Updated: 2020-05-15
Results Overview
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-15
Participant Flow
At clinical site
The study recruited 45 eligible patients. However, three patients were excluded before assignment to groups. Two recruited patients never presented for treatment and one declined to proceed.
Participant milestones
| Measure |
CAF Plus Connective Tissue Graft
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
Tunnel Plus Connective Tissue Graft
The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Flaps for Root Coverage
Baseline characteristics by cohort
| Measure |
CAF Plus Connective Tissue Graft
n=21 Participants
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
Tunnel Plus Connective Tissue Graft
n=21 Participants
The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.66 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
39.71 years
STANDARD_DEVIATION 10.38 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Gingival recession depth
|
3.2 millimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.0 millimeters
STANDARD_DEVIATION 0.6 • n=7 Participants
|
3.0 millimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
Outcome measures
| Measure |
CAF Plus Connective Tissue Graft
n=21 Participants
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
Tunnel Plus Connective Tissue Graft
n=21 Participants
The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
|---|---|---|
|
Percentage of Defect Coverage
|
87.2 percentage of root coverage
Standard Deviation 27.1
|
77.4 percentage of root coverage
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: 6 monthsThe Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score.
Outcome measures
| Measure |
CAF Plus Connective Tissue Graft
n=42 photographs
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
Tunnel Plus Connective Tissue Graft
n=42 photographs
The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
|
|---|---|---|
|
Root Coverage Esthetic Score
|
8.12 units on a scale
Standard Deviation 1.55
|
7.98 units on a scale
Standard Deviation 1.74
|
Adverse Events
CAF Plus Connective Tissue Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tunnel Plus Connective Tissue Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mauro P. Santamaria
Institute of Science and Technology of São José dos Campos (Unesp)
Phone: +55 (16) 981937777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place