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OpenTrials
Completed

NCT Number: NCT06073678

Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

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.

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Other

Irradiation with red laser on palate wound each 48h for 4 sessions.

Other names: Low level laser treatment, Low intensity laser treatment

Protection with surgical dressing

Other

Protection of the palatal wound with surgical dressing for 7 days

Other names: Protection of wound

Primary outcomes

  1. Somatosensory recovery

    Time frame: 30 and 60 days postoperatively

    Mechanical and pain detection threshold measured with Von Frey filaments

Secondary outcomes

  1. Assessment of Pain

    Time frame: 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.

  2. Measurement of Quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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