NCT06073678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

September 25, 2023

Last Update Submit

April 27, 2026

Conditions

Surgical Wound

Outcome Measures

Primary Outcomes (1)

  • Somatosensory recovery

    Mechanical and pain detection threshold measured with Von Frey filaments

    30 and 60 days postoperatively

Secondary Outcomes (2)

  • Assessment of Pain

    24 hours, 3 days, 7 days and 14 days

  • Measurement of Quality of life

    Baseline, 7 days and 14 days postoperatively

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Protection of wound with surgical dressing during 7 days.

Other: Protection with surgical dressing

Interventions

PhotobiomodulationOTHER

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

Also known as: Low level laser treatment, Low intensity laser treatment
Photobiomodulation
Protection with surgical dressingOTHER

Protection of the palatal wound with surgical dressing for 7 days

Also known as: Protection of wound
Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Palate with normal and healthy mucosa
  • Patient with indication of gingival graft surgery

You may not qualify if:

  • Patients using prosthesis with palate coverage
  • Former removal of gingival graft in the palate
  • Smokers
  • Pregnancy and breastfeeding mothers
  • Use of anticonvulsants and immunosuppressors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 32613416BACKGROUND

  • 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.

    PMID: 25373688BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 10, 2023

Study Start

October 1, 2023

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)