NCT03576339

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

June 5, 2018

Last Update Submit

June 21, 2018

Conditions

Palatal Wound

Keywords

Wound HealingElectrical StimulationPalatal

Outcome Measures

Primary Outcomes (1)

  • Remaining wound area

    The defect area will be measured after 7 post-operative days. For this, standardized photography will be taken ( in terms of brightness, distance and angle). A scale will be used as a reference to measure the area. These photographs will be exported to image software (Image J-NIH, Bethesda, USA) and the wound area will be measured in square millimeters (mm2) (Dias et al. 2015).

    7 days

Secondary Outcomes (7)

  • Scar and tissue colorimetry

    30 days

  • Epithelialization

    7 days

  • Tissue thickness

    90 days

  • Postoperative discomfort

    7 days

  • Number of analgesics

    2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Sham Group - Free Gingival Graft + Sham Electric Stimulation

SHAM COMPARATOR

With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 9 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. Patient randomized to the SHAW Group will receive the simulation of the electrical stimulation process, thus non current will be applied.

Procedure: Free Gingival GraftDevice: SHAM Electric stimulation

Test Group - Free Gingival Graft + Electric Stimulation

EXPERIMENTAL

With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 9 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. 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.

Procedure: Free Gingival GraftDevice: Electric Stimulation

Interventions

Free Gingival GraftPROCEDURE

Free gingival graft removal from palate for socket preservation

Also known as: Socket preservation
Sham Group - Free Gingival Graft + Sham Electric StimulationTest Group - Free Gingival Graft + Electric Stimulation
SHAM Electric stimulationDEVICE

Simulation of electric stimulation protocol for 120 seconds once a day in five consecutive days. In Sham stimulation non current will be applied.

Sham Group - Free Gingival Graft + Sham Electric Stimulation
Electric StimulationDEVICE

Local Electric Stimulation for 120 seconds once a day in five consecutive days.

Also known as: Local Electric Stimulation
Test Group - Free Gingival Graft + Electric Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuela Maria Viana Miguel

São José dos Campos, São Paulo, 12243700, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22025904BACKGROUND

  • 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: 22891771BACKGROUND

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Mauro P Santamaria, PhD

    ICT- UNESP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro P Santamaria, PhD

CONTACT

+55 (12) 3947-9000mauro.santamaria@ict.unesp.br

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

June 5, 2018

First Posted

July 3, 2018

Study Start

April 2, 2018

Primary Completion

March 30, 2019

Study Completion

November 30, 2019

Last Updated

July 3, 2018

Record last verified: 2018-06

Locations

BR(1)