Electrical Stimulation Effect on Coronally Advanced Flap
Condition: Gingival Recession, Generalized
MeSH terms: Gingival Recession
Study type: Interventional

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.
    

Intervention name(s): CAF; ES; SHAM
Intervention type(s): Procedure; Device; Device
Intervention description(s): Periodontal plastic surgery for root coverage by the trapezoidal flap; Local electric stimulation for 120 seconds, once a day for a week; Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
Other intervention name(s): Periodontal plastic surgery; Local electric stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment