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

The Effect of Low-Level Laser Therapy on Patient's Pain and Healing of Palatal Donor Site Following Free Gingival Graft: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Radiation: Low-level laser therapy; Radiation: Turned-off laser

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Neda Moslemi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: Low-level laser therapy; Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds; Other Names: low-level laser
Placebo Comparator: Turned-off laser; The same protocol is applied in te donor site, unless the laser is remained off.	Radiation: Turned-off laser; Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of epithelialization	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	At day 7
degree of epithelialization	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	At day 14
degree of epithelialization	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	At day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 1
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 2
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 3
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 4
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 5
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 6
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 7
Visual analogue scale (VAS) pain score	ask from patient about numbers of tablet consumption,record VAS analysis	at day 14
Clinical healing	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.	at day 1
Clinical healing	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.	at day 2
Clinical healing	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.	at day 7
Clinical healing	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.	at day 14
Clinical healing	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.	at day 21

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Neda Moslemi, Laser Research Center of Dentistry, Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 15, 2012
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: low-level laser therapy; gingival recession; wound healing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 91-01-97-16886