Clinical trial NCT03576339: Influence of Electrical Stimulation on Palatal Wound Healing.
Official title: Influence of Electrical Stimulation on Palatal Wound Healing. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palatal Wound
Keywords: Wound Healing
Electrical Stimulation
Palatal
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this present study is to evaluate the clinical and patients-centered parameters of electric stimulation on wound healing process of the donor palatal area after free gingival graft (FGG) removal.

Detailed description: This is a randomized, parallel, double-blind clinical trial. The population that will be evaluated in this is study will be select at Science and Technology Institute - ICT-Sao Jose dos Campos, College of Dentistry.

Patients will be assigned to one of the treatments groups:

* Sham Group - Free Gingival Graft (n = 22): Atraumatic extraction surgery and free gingival graft for sealing the entrance of the alveolus associated with SHAM electrical stimulation simulation.
* Test Group - Free Gingival Graft + Electric stimulus (n = 22): Atraumatic extraction surgery with placement of a free gingival graft to seal the entrance of the alveolus associated with electrical stimulation in the open wound on the palate.

All surgeries will be performed by the same expert periodontist (MMVM). A blade 15c (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. With the aim to ridge preservation after tooth extraction the socket will be sealed with a free gingival graft removed from the palate. For the free gingival graft removal, a circular template of 9 millimeters in diameter will be used. This mold has the objective of standardizing the palatal graft removal ensuring the wounds will have always the same size. After the circular incision, the graft will be removed with a thickness of 2 millimeters. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil, São José dos Campos - SP).

For electrical stimulation, a unit consisting of a signal generator (Keysight Technologies., Inc., Santa Rosa-CA, USA), a power supply (Keysight Technologies., Inc., Santa Rosa-CA, USA) and circuit board will be used. Conductive electrodes for electrical current application will be applied to the palatal donor area on each side of the wound at a distance of 3 mm from the wound edge. 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, five consecutive days. 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.

The evaluated clinical parameters will be: wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and epithelization (E). Moreover, patient-centered also will be evaluated as: number of pills (NP), tissue edema (TE), postoperative discomfort (D) and Oral Health Impact Profile (OHIP).

All data will be expressed as mean ± standard deviation (SD), and normality will be tested using the Shapiro-Wilk test. Values for remaining wound area, scar and tissue colorimetry, tissue thickness, and epithelization will be examined by repeated measures ANOVA to assess differences within and between groups, followed by a Tukey test for multiple comparisons when the value of p Shapiro-Wilk ≥ 0.05. Those with Shapiro-Wilk p values \<0.05 will be analyzed using the Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Values referring to patient-centered parameters such as postoperative discomfort, the number of analgesics taken, tissue edema and oral health impact profile measurements will be analyzed using the T-Test.

Eligibility criteria: Inclusion Criteria:

* Patients with at least 18 years of age, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index of less than 25% (O'Leary et al., 1972);
* Patients with no morphological or pathological changes in the donor palatine region;
* Patients who present indication of exodontia and with ridge preservation indication for future implantation of implants;
* The tooth included in the study, as well as the adjacent teeth do not present a loss of periodontal insertion;
* Patients who agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).

Exclusion Criteria:

* Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
* Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
* Smokers patients;
* Pregnant or lactating patients;
* Patients who had had periodontal surgery on the study area;
* Patients who present opportunistic oral lesions, mainly colonized the palate region;
* Patient using a pacemaker.

Primary outcomes:
measure: Remaining wound area
timeFrame: 7 days
Secondary outcomes:
measure: Scar and tissue colorimetry
timeFrame: 30 days
measure: Epithelialization
timeFrame: 7 days
measure: Tissue thickness
timeFrame: 90 days
measure: Postoperative discomfort
timeFrame: 7 days
measure: Number of analgesics
timeFrame: 2 weeks
measure: Tissue edema
timeFrame: 7 days
measure: Oral Health Impact Profile
timeFrame: 2 weeks
Other outcomes:
Locations:
city: São José Dos Campos
country: Brazil
facility: Manuela Maria Viana Miguel
state: Sao Paulo
Study officials:
affiliation: ICT- UNESP
name: Mauro P Santamaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao M, Penninger J, Isseroff RR. Electrical Activation of Wound-Healing Pathways. Adv Skin Wound Care. 2010 Jan 1;1:567-573. doi: 10.1089/9781934854013.567.
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.