Trial Outcomes & Findings for Electrical Stimulation Effect on Coronally Advanced Flap (NCT NCT02987231)
NCT ID: NCT02987231
Last Updated: 2019-08-07
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
60 participants
Primary outcome timeframe
6 months
Results posted on
2019-08-07
Participant Flow
At clinical site
The study recruited 66 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 + SHAM
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. 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. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
|
CAF + ES
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
ES: Local electric stimulation for 120 seconds, once a day for a week
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation Effect on Coronally Advanced Flap
Baseline characteristics by cohort
| Measure |
CAF + SHAM
n=30 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. 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. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
|
CAF + ES
n=30 Participants
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
ES: Local electric stimulation for 120 seconds, once a day for a week
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
39.86 years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
41.13 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 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
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Gingival recession depth
|
3.09 millimeters
STANDARD_DEVIATION 0.41 • n=5 Participants
|
3.2 millimeters
STANDARD_DEVIATION 0.58 • n=7 Participants
|
3.18 millimeters
STANDARD_DEVIATION 0.11 • 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 + SHAM
n=30 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. 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. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
|
CAF + ES
n=30 Participants
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
ES: Local electric stimulation for 120 seconds, once a day for a week
|
|---|---|---|
|
Percentage of Defect Coverage
|
79.47 percentage of root coverage
Standard Deviation 21.19
|
85.97 percentage of root coverage
Standard Deviation 17.41
|
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. The final score ranged from 0-10, higher values were considered better.
Outcome measures
| Measure |
CAF + SHAM
n=30 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. 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. Patients randomized to the SHAM Group will receive the simulation of the electrical stimulation process.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
SHAM: Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
|
CAF + ES
n=30 Participants
CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. The flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ. For electrical stimulation, a unit consisting of a signal generator, a power supply, and a circuit board will be used. Conductive electrodes for electrical current application will be applied to the vestibular gingival surface on each side of the flap, at a distance of 3 mm from the relaxing incisions and an alternating current of 100 μA at 9 kHz, will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, once a day for five days after surgery.
CAF: Periodontal plastic surgery for root coverage by the trapezoidal flap
ES: Local electric stimulation for 120 seconds, once a day for a week
|
|---|---|---|
|
Root Coverage Esthetic Score
|
8.03 units on a scale
Standard Deviation 0.37
|
7.9 units on a scale
Standard Deviation 0.23
|
Adverse Events
CAF + SHAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAF + ES
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