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NCT Number: NCT07308912

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

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.

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Key information

Conditions

Low Level Laser Therapy Agnosia Healthy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Pain Management Signs and Symptoms Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: Diode laser, Low-level laser therapy (LLLT), Photobiomodulation therapy (PBMT)

palatal stent

Device

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

Primary outcomes

  1. Postoperative pain

    Time frame: 2 hours, 3 days, and 7 days after surgery

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

  2. Post-surgical analgesic consumption

    Time frame: Within 3 days after surgery

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

  3. Epithelialization of the palatal donor site

    Time frame: Day 7 and 14 after surgery

    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).

  4. Remaining wound area

    Time frame: Immediately after surgery, and 3, 7, and 14 days after surgery

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

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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