Effect of Low-level Laser Therapy on Palatal Wound Healing

NCT02239042 | Completed Phase 4

• 1 other identifier: 132.831
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft.

Conditions

Palatal Wound

Keywords

Gingival recessions

Outcome Measures

Primary Outcomes (1)

• Change in the Remaining wound area (RWA)

  For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters

  7, 14, 45 and 60 post-operative days

Secondary Outcomes (1)

• Post-operative discomfort

  7, 14, 45 and 60 days after surgical procedure

Other Outcomes (1)

• Tissue thickness

  Before and 90 days after surgery

Study Arms (2)

Low-level laser therapy (LLLT) Sham

SHAM COMPARATOR

LLLT Sham on the palatal donor site of connective tissue graft

Procedure: LLLT

Low-level laser therapy (LLLT)

EXPERIMENTAL

LLLT on the palatal donor site of connective tissue graft

Procedure: LLLT

Interventions

LLLT PROCEDURE

The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue

Also known as: Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor site

Low-level laser therapy (LLLT); Low-level laser therapy (LLLT) Sham

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that were 20 to 70 years old, both genders; presenting gingival recession Class I or II Miller, on vital canines or pre-molars, palatine region (donor site) with no pathological or morphological alterations; patients who agreed with and signed the formal consent to participate in the study, after receiving an explanation of risks and benefits, by an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO 179/93).

You may not qualify if:

• Patients with systemic problems that contraindicated surgical procedure; patients under medication that would interfere with the wound healing; patients who smoked; patients who were pregnant or lactating; patients who had had periodontal surgery on the study area.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Fosjc-Unesp

São Jose Dos Campos/ SP, Non-US Resident, 12245-000, Brazil

Location

Related Publications (1)

• Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.

  PMID: 25373688 DERIVED

MeSH Terms

Conditions

Gingival Recession

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mauro Santamaria, DDS, Ms, PhD

  FOSJC-UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher - Principal investigator

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 12, 2014
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

BR (1)