Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness

NCT02865902 | Completed

• 1 other identifier: 24237859-545
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: The aim of this study was to determine the effects of Low Level Laser Therapy (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS). Materials and Methods: Forty patients requiring FGG were selected for this randomized controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency, colour match (CM), and H2O2 bubbling test for the evaluation of complete wound epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue thickness (TT) was measured at baseline and at the 1st month.

Conditions

Wounds

Keywords

Low level laser therapy; wound healing; periodontology

Outcome Measures

Primary Outcomes (1)

• Complete Wound Epithelization

  The 14th day H2O2 Bubbling test results that show Complete Wound Epithelization

  14th. day after surgery

Secondary Outcomes (1)

• Palatal Tissue Thickness

  at baseline and at the 1st month

Study Arms (2)

Test Group

EXPERIMENTAL

In Test group, the free gingival graft donor sites of each experimental group received low-level laser therapy by Ezlase; Biolase® at doses of 8.6 J/cm2.

Device: Low-Level Laser Therapy by Ezlase; Biolase®

Control Group

SHAM COMPARATOR

In Control Group, the low-level laser therapy by Ezlase; Biolase® was performedin a same manner with test group at free gingival graft donor sites. However, no irradiation was occurred because of not pushing the start button.

Device: Low-Level Laser Therapy by Ezlase; Biolase®

Interventions

Low-Level Laser Therapy by Ezlase; Biolase® DEVICE

comparision of the effects of low-level-laser therapy on wound healing of palatal donor site

Control Group; Test Group

Eligibility Criteria

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

You may qualify if:

• The absence of systemic factors (no systemic disease, no coagulation disorders, no medications affecting periodontal status, and no pregnancy or lactation)
• No smoking
• Patients who had a full mouth plaque score (FMPS)˂20% and a full mouth bleeding score (FMBS)˂20%
• No periodontal surgery on the experimental site
• No nauseal reflection

You may not qualify if:

• Smoking
• The presence of systemic disease
• Bad oral hygiene-
• The history of periodontal surgery on the experimental site
• Nauseal reflection

Sponsors & Collaborators

• Karadeniz Technical University: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseach Asistant

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 15, 2016
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 15, 2016

Record last verified: 2016-08