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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06073678
Other study ID # Photobiomodulation in palate
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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