Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073678
• Other study ID #: Photobiomodulation in palate
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: University of Sao Paulo
• Contact: Carla Damante, PhD
• Phone: +55 14 32358366
• Email: cdamante[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2025
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Other:
• Photobiomodulation
Irradiation with red laser on palate wound each 48h for 4 sessions.
• Protection with surgical dressing
Protection of the palatal wound with surgical dressing for 7 days

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6. — View Citation

Zhao H, Hu J, Zhao L. The effect of low-level laser therapy as an adjunct to periodontal surgery in the management of postoperative pain and wound healing: a systematic review and meta-analysis. Lasers Med Sci. 2021 Feb;36(1):175-187. doi: 10.1007/s10103-020-03072-5. Epub 2020 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Somatosensory recovery	Mechanical and pain detection threshold measured with Von Frey filaments	30 and 60 days postoperatively
Secondary	Assessment of Pain	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
Secondary	Measurement of Quality of life	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