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

Biomodulatory Effects of GaAlAs 940 nm on Pain Control and Wound Healing at Palatal Donor Site Following Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Wound Healing; Postoperative Pain Management; Low Level Laser Therapy
• Intervention / Treatment: Device: 940 nm GaAlAs diode laser; Device: palatal stent

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥18 years of age;
2. systemically healthy individuals without any conditions that could affect wound healing (e.g., diabetes, immunosuppression, coagulation disorders, Candida infection;
3. full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <15%;
4. no previous history of palatal tissue harvesting;
5. no use of overdentures or partial dentures covering the donor area.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; 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; 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.; Other Names: Low-level laser therapy (LLLT); Diode laser; Photobiomodulation therapy (PBMT)
Active Comparator: Control group; After suturing was completed at the recipient site. In the control group, only the palatal stent was applied without laser irradiation.	Device: palatal stent; In the control group, only the palatal stent was applied without laser irradiation after suturing was completed at the recipient site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: low level laser therapy; photobiomodulation; pain control; palatal donor site; palatal wound healing; free gingival harvesting
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Therapeutics; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Laser Therapy; Phototherapy; Lasers, Semiconductor; Low-Level Light Therapy
• Other Study ID Numbers: 1976/ĐHYD-HĐĐĐ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes