Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

April 27, 2026 updated by: Carla Andreotti Damante, University of Sao Paulo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17012-901
        • Bauru School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photobiomodulation
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
Irradiation with red laser on palate wound each 48h for 4 sessions.
Other Names:
  • Low level laser treatment
  • Low intensity laser treatment
Active Comparator: Control
Protection of wound with surgical dressing during 7 days.
Other: Protection with surgical dressing
Protection of the palatal wound with surgical dressing for 7 days
Other Names:
  • Protection of wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Somatosensory recovery
Time Frame: 30 and 60 days postoperatively
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
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.
24 hours, 3 days, 7 days and 14 days
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.
Baseline, 7 days and 14 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Photobiomodulation in palate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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