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Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT06073678
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Photobiomodulation
  • Other: Protection with surgical dressing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups
Primary Purpose:
Treatment
Official Title:
Photobiomodulation in Gingival Graft Donor Areas: Clinical, Somatosensory, and Quality of Life Evaluations
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 23, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Somatosensory recovery [30 and 60 days postoperatively]

      Mechanical and pain detection threshold measured with Von Frey filaments

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bauru School of Dentistry Bauru São Paulo Brazil 17012-901

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Carla Andreotti Damante, Associate professor, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT06073678
    Other Study ID Numbers:
    • Photobiomodulation in palate
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Surgical Wound

    Study Results

    No Results Posted as of Oct 10, 2023