Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

University of Sao Paulo30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Surgical Wound

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Somatosensory recovery

Mechanical and pain detection threshold measured with Von Frey filaments

Time frame: 30 and 60 days postoperatively

Secondary Outcomes

Assessment of Pain

Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain.

Time frame: 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.

Time frame: Baseline, 7 days and 14 days postoperatively