Trial Outcomes & Findings for A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL) (NCT NCT02817763)
NCT ID: NCT02817763
Last Updated: 2017-12-11
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
40 participants
Primary outcome timeframe
6 months
Results posted on
2017-12-11
Participant Flow
At clinical site
The study recruited 45 eligible patients. However, five patients were excluded before assignment to groups. One recruited patient never presented for treatment and four declined to proceed.
Participant milestones
| Measure |
Connective Tissue Graft (CTG)
After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
CTG Plus Resin Composite Restoration
After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL)
Baseline characteristics by cohort
| Measure |
Connective Tissue Graft (CTG)
n=20 Participants
After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
CTG Plus Resin Composite Restoration
n=20 Participants
After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.52 years
STANDARD_DEVIATION 10.26 • n=5 Participants
|
44.35 years
STANDARD_DEVIATION 10.39 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 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
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Gingival recession depth
|
3.34 millimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.29 millimeters
STANDARD_DEVIATION 1.13 • n=7 Participants
|
3.31 millimeters
STANDARD_DEVIATION 0.03 • 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 |
Connective Tissue Graft (CTG)
n=20 Gingival recessions
After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
CTG Plus Resin Composite Restoration
n=20 Gingival recessions
After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
|---|---|---|
|
Percentage of Defect Coverage
|
15 Gingival recessions
|
14 Gingival recessions
|
SECONDARY outcome
Timeframe: 6 monthsThe MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth's color; 3 points = good color integration. Thus, 10 points was a perfect score.
Outcome measures
| Measure |
Connective Tissue Graft (CTG)
n=40 photographs
After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
CTG Plus Resin Composite Restoration
n=20 Participants
After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures.
|
|---|---|---|
|
Modified Root Coverage Esthetic Score (MRES)
|
7.13 units on a scale
Standard Deviation 0.07
|
8.71 units on a scale
Standard Deviation 0.89
|
Adverse Events
Connective Tissue Graft (CTG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTG Plus Resin Composite Restoration
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