Gingival Recession, Generalized Clinical Trial
Official title:
Electrical Stimulation Effect on Coronally Advanced Flap for the Treatment of Gingival Recession: Randomized Controlled Clinical Trial
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.
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.
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