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Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

U

University of Sao Paulo

Status

Enrolling

Conditions

Surgical Wound

Treatments

Other: Photobiomodulation
Other: Protection with surgical dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT06073678
Photobiomodulation in palate

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Photobiomodulation
Experimental group
Description:
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.
Treatment:
Other: Photobiomodulation
Control
Active Comparator group
Description:
Protection of wound with surgical dressing during 7 days.
Treatment:
Other: Protection with surgical dressing

Trial contacts and locations

1

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Central trial contact

Carla Damante, PhD

Data sourced from clinicaltrials.gov

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