Electrical Stimulation Effect on Coronally Advanced Flap

NCT02987231 | Completed Results

• 1 other identifier: UEPJMF 5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession, Generalized

Outcome Measures

Primary Outcomes (1)

• Percentage of Defect Coverage

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

  6 months

Secondary Outcomes (1)

• Root Coverage Esthetic Score

  6 months

Study Arms (2)

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.

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.

Procedure: CAF; Device: ES

Interventions

CAF PROCEDURE

Periodontal plastic surgery for root coverage by the trapezoidal flap

Also known as: Periodontal plastic surgery

CAF + ES; CAF + SHAM

ES DEVICE

Local electric stimulation for 120 seconds, once a day for a week

Also known as: Local electric stimulation

CAF + ES

SHAM DEVICE

Simulation of electric stimulation protocol. In Sham stimulation non current will be applied

CAF + SHAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Felipe Lucas da Silva Neves

São José dos Campos, São Paulo, 12243-700, Brazil

Location

Related Publications (2)

• 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.

  PMID: 17309597 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.

  PMID: 22891771 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Dr. Mauro P. Santamaria
• Organization: Institute of Science and Technology of São José dos Campos (Unesp)

mauro.santamaria@unesp.br

+55 (16) 981937777

Study Officials

• Mauro P Santamaria, PhD

  ICT-UNESP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Locations

BR (1)