Gingival Recession, Generalized
Conditions
Brief summary
The objective of this study is to evaluate clinically and through the concentration of inflammatory markers, the results of 6 months of electrical stimulation associated with coronally advanced flap for treatment of gingival recession.
Detailed description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry. Sixty patients presenting gingival recession will be divided in 2 groups: * CAF group: coronally advanced flap for root coverage and sham electrical stimulation * CAF+ES group: coronally advanced flap for root coverage plus electrical stimulation. All surgical procedures were performed by a single operator (MPS). The gingival recession defects were randomly treated by either the trapezoidal-type of coronally advanced flap plus connective tissue graft (CAF+CTG). In brief description, 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 and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the cement-enamel junction (CEJ), followed by interrupted sutures to close the releasing incisions. For electrical stimulation, a unit consisting of a signal generator (WaveFactoryCo., Ltd., Tokyo, Japan), a power supply (KikusuiElectronicsCo., Ltd., Tokyo, Japan) and 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 microamperes (μA) at 9 kilohertz (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 a week. The electric current will have its visualization optimized through an oscilloscope. Patients randomized to the Control Group (SHAM) will receive the simulation of the electrical stimulation (ES) process. Clinical, esthetics, and comfort of patients parameters were assessed at 45 days, 2, 3 and 6 months after the procedure. Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW), and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to evaluate the differences within and between groups, followed by a Tukey test for multiple comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values \< 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were performed with a T-test. A significance level of 0.05 was adopted.
Interventions
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars * Visible cemento-enamel junction (CEJ) with pulp vitality; * Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤20%; * Patients older than 18 years old; probing depth ˂3 mm in the included teeth; * Patients who agreed to participate and signed an informed consent form.
Exclusion criteria
* Patients presenting systemic problems that would contraindicate the surgical procedure; * Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure; * Smokers or pregnant women; * Patients who underwent periodontal surgery in the area of interest; * Patients with orthodontic therapy in progress.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Defect Coverage | 6 months | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Root Coverage Esthetic Score | 6 months | The 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. |
Countries
Brazil
Participant flow
Recruitment details
At clinical site
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | CAF + SHAM | CAF + ES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 29 Participants | 59 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 12.68 | 39.86 years STANDARD_DEVIATION 10.14 | 41.13 years STANDARD_DEVIATION 11.45 |
| Gingival recession depth | 3.09 millimeters STANDARD_DEVIATION 0.41 | 3.2 millimeters STANDARD_DEVIATION 0.58 | 3.18 millimeters STANDARD_DEVIATION 0.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 28 Participants | 52 Participants |
| Region of Enrollment Brazil | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Percentage of Defect Coverage
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAF + SHAM | Percentage of Defect Coverage | 79.47 percentage of root coverage | Standard Deviation 21.19 |
| CAF + ES | Percentage of Defect Coverage | 85.97 percentage of root coverage | Standard Deviation 17.41 |
Secondary
Root Coverage Esthetic Score
The 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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAF + SHAM | Root Coverage Esthetic Score | 8.03 units on a scale | Standard Deviation 0.37 |
| CAF + ES | Root Coverage Esthetic Score | 7.9 units on a scale | Standard Deviation 0.23 |