Surgical Wound
Conditions
Brief summary
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.
Interventions
OTHERPhotobiomodulation
Irradiation with red laser on palate wound each 48h for 4 sessions.
OTHERProtection with surgical dressing
Protection of the palatal wound with surgical dressing for 7 days
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Somatosensory recovery | 30 and 60 days postoperatively | Mechanical and pain detection threshold measured with Von Frey filaments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain | 24 hours, 3 days, 7 days and 14 days | Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain. |
| Measurement of Quality of life | Baseline, 7 days and 14 days postoperatively | 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. |
Countries
Brazil
Outcome results
None listed