MedDataX Logo

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

NCT ID: NCT07308912

Last Updated: 2025-12-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Level Laser Therapy Healthy Postoperative Pain Management Wound Healing

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

940 nm GaAlAs diode laser

Intervention Type 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.

Control group

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

Group Type ACTIVE_COMPARATOR

palatal stent

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

palatal stent

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diode laser Low-level laser therapy (LLLT) Photobiomodulation therapy (PBMT)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Le Thanh Nguyen

Resident Physician, Department of Periodontics, University of Dentistry, HCMC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Ho Chi Minh City, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1976/ĐHYD-HĐĐĐ

Identifier Type: -

Identifier Source: org_study_id