Gingival Recession, GeneralizedNCT02987231
Electrical Stimulation Effect on Coronally Advanced Flap
A study testing CAF and ES in people with Gingival Recession, Generalized, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Generalized
- What is being tested?
- CAF and ES
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Felipe Lucas da Silva Neves
São José dos Campos, São Paulo, 12243-700
About this study
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.
Read the 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.
- Conditions
- Gingival Recession, Generalized
- Being tested
- CAF, ES, SHAM
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAFProcedure or surgery
Also called Periodontal plastic surgery
Periodontal plastic surgery for root coverage by the trapezoidal flap
ESDevice
Also called Local electric stimulation
Local electric stimulation for 120 seconds, once a day for a week
SHAMDevice
Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CAF; Device: SHAM |
| 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. Receives: Procedure: CAF; Device: ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Defect Coverage
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, PhD, Principal investigator, ICT-UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987231
- Sponsor's protocol ID
- UEPJMF 5
- Status last verified
- Aug 2019
- First submitted
- 6 Dec 2016
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17309597Tomofuji 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.
PubMed 22891771
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation Effect on Coronally Advanced Flap for the Treatment of Gingival Recession: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02987231
- Acronym / sponsor ID
- UEPJMF 5
- Conditions
- Gingival Recession, Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF + SHAM | Sham comparator | Procedure: CAF, Device: SHAMCAF 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 | Procedure: CAF, Device: ESCAF 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAFAlso: Periodontal plastic surgeryPeriodontal plastic surgery for root coverage by the trapezoidal flap | Procedure or surgery | CAF + ES, CAF + SHAM |
| ESAlso: Local electric stimulationLocal electric stimulation for 120 seconds, once a day for a week | Device | CAF + ES |
| SHAMSimulation of electric stimulation protocol. In Sham stimulation non current will be applied | Device | CAF + SHAM |
Primary outcome
Percentage of Defect Coverage
Time frame: 6 months
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
1 secondary outcome
Root Coverage Esthetic Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17309597de 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.
- Background: PubMed 22891771Tomofuji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro P Santamaria, PhD principal investigator
ICT-UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF and ES in people with Gingival Recession, Generalized, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Defect Coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02987231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.