Effect of GaAlAs 940 Laser on Pain and Wound Healing After Free Gingival Graft

NCT07308912 | Completed FDA Device

• 1 other identifier: 1976/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Adult patients undergoing free gingival graft surgery will be randomly allocated to receive either a single session of adjunctive diode laser irradiation immediately after surgery or conventional postoperative care alone. Postoperative pain will be assessed using a visual analog scale, while clinical parameters related to wound healing, including bleeding tendency, epithelialization, and wound size reduction, will be evaluated at predefined follow-up time points. The findings of this study may contribute to the clinical understanding of photobiomodulation in free gingival graft surgery.

Conditions

Low Level Laser Therapy; Healthy; Postoperative Pain Management; Wound Healing

Keywords

low level laser therapy; palatal donor site; free gingival harvesting; pain control; palatal wound healing; photobiomodulation

Outcome Measures

Primary Outcomes (4)

• Postoperative pain

  Zero is equivalent to no pain and 10 indicates the worst possible pain.

  2 hours, 3 days, and 7 days after surgery

• Post-surgical analgesic consumption

  The number of 500-mg acetaminophen tablets consumed by participants during the first 3 days after surgery.

  Within 3 days after surgery

• Epithelialization of the palatal donor site

  Epithelialization at the palatal donor site assessed as a binary outcome (yes/no) using a hydrogen peroxide bubbling test, classified as non-epithelialized (presence of bubbles) or completely epithelialized (absence of bubbles).

  Day 7 and 14 after surgery

• Remaining wound area

  Changes in palatal donor site wound area measured using serial intraoral digital scans obtained at predefined follow-up time points

  Immediately after surgery, and 3, 7, and 14 days after surgery

Study Arms (2)

Laser group

EXPERIMENTAL

After suturing was completed at the recipient site, the donor site in the laser group was irradiated according to the manufacturer's recommended settings. Laser application was performed in the "Pain Therapy" mode using an Epic X diode laser (940 nm wavelength; 0.1 W power; energy density 4 J/cm²; continuous mode; exposure time 40 s; total energy 12 J). The laser beam was held perpendicular to the donor-site wound surface at 0.5 cm, with a spot size of 1 cm². Following irradiation, a palatal stent was placed.

Device: 940 nm GaAlAs diode laser

Control group

ACTIVE COMPARATOR

After suturing was completed at the recipient site. In the control group, only the palatal stent was applied without laser irradiation.

Device: palatal stent

Interventions

940 nm GaAlAs diode laser DEVICE

A single session of 940-nm GaAlAs diode laser irradiation is applied to the palatal donor site immediately after free gingival graft harvesting using a continuous, non-contact mode (0.1 W, 4 J/cm² for 40 seconds), in combination with the use of a palatal stent.

Also known as: Diode laser, Low-level laser therapy (LLLT), Photobiomodulation therapy (PBMT)

Laser group

palatal stent DEVICE

In the control group, only the palatal stent was applied without laser irradiation after suturing was completed at the recipient site

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age;
• systemically healthy individuals without any conditions that could affect wound healing (e.g., diabetes, immunosuppression, coagulation disorders, Candida infection;
• full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<15%;
• no previous history of palatal tissue harvesting;
• no use of overdentures or partial dentures covering the donor area.

You may not qualify if:

• pregnant or breastfeeding women;
• smokers;
• patients with psychiatric disorders; and
• patients taking any medications that impair tissue healing and affect pain perception.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lasers, Semiconductor; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Periodontal surgeries are performed by a periodontist with more than 20 years of clinical experience, who is not involved in laser irradiation or clinical outcome assessment. Laser irradiation and digital scanning of the palatal wound area are performed by a trained investigator who does not participate in clinical outcome evaluation. Clinical assessments and measurements of scanned images are conducted by an independent periodontist who is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Periodontics, University of Dentistry, HCMC

Model Details: Participants are randomly assigned to two groups: a laser group receiving adjunctive 940-nm diode laser irradiation in combination with a palatal stent, and a control group receiving a palatal stent alone following free gingival graft harvesting

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: December 30, 2025
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

VN (1)