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Electrical Stimulation Effect on Coronally Advanced Flap

Primary Purpose

Gingival Recession, Generalized

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CAF
ES
SHAM
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Generalized

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Felipe Lucas da Silva Neves

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

CAF + SHAM

CAF + ES

Arm 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. 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 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. For electrical stimulation, a unit consisting of a signal generator, a power supply, 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 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.

Outcomes

Primary Outcome Measures

Percentage of Defect Coverage
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

Secondary Outcome Measures

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.

Full Information

First Posted
December 6, 2016
Last Updated
August 5, 2019
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT02987231
Brief Title
Electrical Stimulation Effect on Coronally Advanced Flap
Official Title
Electrical Stimulation Effect on Coronally Advanced Flap for the Treatment of Gingival Recession: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAF + SHAM
Arm Type
Sham Comparator
Arm 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. 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.
Arm Title
CAF + ES
Arm Type
Experimental
Arm 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. 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. For electrical stimulation, a unit consisting of a signal generator, a power supply, 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 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.
Intervention Type
Procedure
Intervention Name(s)
CAF
Other Intervention Name(s)
Periodontal plastic surgery
Intervention Description
Periodontal plastic surgery for root coverage by the trapezoidal flap
Intervention Type
Device
Intervention Name(s)
ES
Other Intervention Name(s)
Local electric stimulation
Intervention Description
Local electric stimulation for 120 seconds, once a day for a week
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
Primary Outcome Measure Information:
Title
Percentage of Defect Coverage
Description
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Root Coverage Esthetic Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
ICT-UNESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Felipe Lucas da Silva Neves
City
Sao Jose dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-700
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17309597
Citation
de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
Results Reference
background
PubMed Identifier
22891771
Citation
Tomofuji T, Ekuni D, Azuma T, Irie K, Endo Y, Kasuyama K, Nagayama M, Morita M. Effects of electrical stimulation on periodontal tissue remodeling in rats. J Periodontal Res. 2013 Apr;48(2):177-83. doi: 10.1111/j.1600-0765.2012.01518.x. Epub 2012 Aug 14.
Results Reference
background

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Electrical Stimulation Effect on Coronally Advanced Flap

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