Effect of Low-Level Laser on Pain and Healing of Donor Site Following Free Gingival Graft

Phase 2

Completed

• Conditions: Gingival Recession
• Interventions: Radiation: Low-level laser therapy; Radiation: Turned-off laser

• Registration Number: NCT02896283
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The aim of this randomized split-mouth design clinical trial is to clinically evaluate the effectiveness of diode laser in the healing of donor site of palate in free gingival graft.

Detailed Description

Free gingival graft is the most predictable and successful method for increasing the width of keratinized tissue around teeth/dental implants and vestibular deepening. However, patient discomfort during the healing time is a major disadvantage of this procedure. Several methods have been introduced to accelerate the healing time and reduction of patient's pain during first days after surgery. Low-level lasers have shown promising results in biostimulation of cell growth and differentiation in cultures. However, there are lack of well designed double blind placebo controlled randomized controlled clinical studies evaluating the effects of Low-level laser therapy in acceleration of wound healing and pain relief of patients undergoing free gingival grafts.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Study First Submitted: 2012-12-15
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-06
• Last Update Submitted: 2016-09-06
• Study First Posted: 2016-09-12
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• lack of keratinized tissue around teeth (bilateral)

Exclusion Criteria

• patients with systemic diseases
• non-cooperative patients
• smokers
• poor oral hygiene
• root surface restorations or active caries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low-level laser therapy	Low-level laser therapy	Low-level laser (Diode, 66o nanometer, power:200 milli Watt (mW), Continuous wave, time of irradiation:32 seconds)is irradiated in donor site
Turned-off laser	Turned-off laser	The same protocol is applied in te donor site, unless the laser is remained off.

Primary Outcome Measures

Name	Time	Method
degree of epithelialization	At day 21	3% hydrogen peroxide (H2O2) was applied to the wound by a sterile gause to see the bubbling; * Complete epithelialization: bubble was not seen; * Partial epithelialization: bubbles were seen in lesser than half of donor site; * No epithelialization: bubble were seen in more than half of donor site

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) pain score	at day 14	ask from patient about numbers of tablet consumption,record VAS analysis
Clinical healing	at day 21	Photographs were taken from donor and recipient sites. Three expert blinded periodontist photographs photographs based on shade,morphology and texture at two sessions by 48 hours interval.

Trial Locations

Locations (1)

Neda Moslemi; 🇮🇷 Tehran, Iran, Islamic Republic of