Tongue Tie Clinical Trials

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Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• Patients aged between 3 and 6 years.

• Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).

• Parents or legal guardians provide informed consent for the child to participate in the study.

• Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).

Locations
Other Locations
Viet Nam
Children's Hospital 1, Department of Odonto-Stomatology
RECRUITING
Ho Chi Minh City
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Phong Dai Lam, PhD, DDS
phonglam@ump.edu.vn
(+84) 906312958
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 53
Treatments
Experimental: Diode Laser Group
Patients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength.
Active_comparator: Electrosurgery Group
Patients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group.
Related Therapeutic Areas
Sponsors
Leads: University of Medicine and Pharmacy at Ho Chi Minh City

This content was sourced from clinicaltrials.gov