Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.

Official Title
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Photobiomodulation in Gingival Graft Donor Areas: Clinical, Somatosensory, and Quality of Life Evaluations

Conditions
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Surgical Wound

Intervention / Treatment
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* Other: Photobiomodulation
* Other: Protection with surgical dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Palate with normal and healthy mucosa Patient with indication of gingival graft surgery Exclusion Criteria: Patients using prosthesis with palate coverage Former removal of gingival graft in the palate Smokers Pregnancy and breastfeeding mothers Use of anticonvulsants and immunosuppressors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br>Red laser irradiation on palate wound at the day of the surgery and after 2, 4 and 6 days postoperatively. Protection of wound with surgical dressing during 7 days. | Other: Photobiomodulation<br>* Irradiation with red laser on palate wound each 48h for 4 sessions.<br>* Other names: Low intensity laser treatment;|
| Active Comparator: Control<br>Protection of wound with surgical dressing during 7 days. | Other: Protection with surgical dressing<br>* Protection of the palatal wound with surgical dressing for 7 days<br>* Other names: Protection of wound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatosensory recovery | Mechanical and pain detection threshold measured with Von Frey filaments | 30 and 60 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pain | Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain. | 24 hours, 3 days, 7 days and 14 days | 
| Measurement of Quality of life | Patients fill the Oral Health Impact Profile (OHIP-14) questionnaire. It comprises 14 questions about oral health problems. In each question the patient may answer if they he have those problems very often (coded 4), fairly often (coded 3), occasionally (coded 2), hardly ever (coded 1) or never (coded 0). Questionnaire scale ranges from 0 to 56 with higher scores indicating poorer quality of life. | Baseline, 7 days and 14 days postoperatively |