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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAF + SHAM | Sham Comparator | 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 + ES | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAF | Procedure | Periodontal plastic surgery for root coverage by the trapezoidal flap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Defect Coverage | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro P Santamaria, PhD | ICT-UNESP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Felipe Lucas da Silva Neves | São José dos Campos | São Paulo | 12243-700 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17309597 | Background | 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. | |
| 22891771 | Background | 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. |
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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.
At clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Defect Coverage | Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe. | Posted | Mean | Standard Deviation | percentage of root coverage | 6 months |
|
The period of data collection related to adverse effects started in the immediate postoperative period up to 6 months of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mauro P. Santamaria | Institute of Science and Technology of São José dos Campos (Unesp) | +55 (16) 981937777 | mauro.santamaria@unesp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2016 | Aug 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ES | Device | Local electric stimulation for 120 seconds, once a day for a week |
|
|
| SHAM | Device | Simulation of electric stimulation protocol. In Sham stimulation non current will be applied |
|
| 6 months |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gingival recession depth | Mean | Standard Deviation | millimeters |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| D055093 |
| Periodontal Atrophy |