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RECRUITING
NCT07557875
NA

Healing Efficacy of Diode Laser in Lingual Frenectomy

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

View on ClinicalTrials.gov

Summary

This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years. Participants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery. The study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification. The goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.

Official title: Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2024-10-01

Completion Date

2026-10-01

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

PROCEDURE

Lingual Frenectomy using 940nm Diode Laser

Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team.

PROCEDURE

Lingual Frenectomy using High-frequency Electrosurgery

Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital.

Locations (2)

Children's Hospital 1, Department of Odonto-Stomatology

Ho Chi Minh City, Vietnam

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

Ho Chi Minh City, Vietnam