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Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

NCT ID: NCT06073678

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups

Study Groups

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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.

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type OTHER

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

Control

Protection of wound with surgical dressing during 7 days.

Group Type ACTIVE_COMPARATOR

Protection with surgical dressing

Intervention Type OTHER

Protection of the palatal wound with surgical dressing for 7 days

Interventions

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Photobiomodulation

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

Intervention Type OTHER

Protection with surgical dressing

Protection of the palatal wound with surgical dressing for 7 days

Intervention Type OTHER

Other Intervention Names

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Low level laser treatment Low intensity laser treatment Protection of wound

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carla Andreotti Damante

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru School of Dentistry

Bauru, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Carla Damante, PhD

Role: CONTACT

Phone: +55 14 32358366

Email: [email protected]

Facility Contacts

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Carla Damante, PhD

Role: primary

Isadora Gasparoto, MD

Role: backup

Carla Damante, PhD

Role: backup

Isadora Gasparoto, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32613416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25373688 (View on PubMed)

Other Identifiers

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Photobiomodulation in palate

Identifier Type: -

Identifier Source: org_study_id