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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gingival Recession

Intervention / Treatment
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* Radiation: Low-level laser therapy
* Radiation: Turned-off laser


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, low-level laser therapy, gingival recession