NCT07557875 Healing Efficacy of Diode Laser in Lingual Frenectomy
| NCT ID | NCT07557875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City |
| Condition | Ankyloglossia |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 53 participants in total. It began in 2024-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline). * Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma). * Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions. * Patients who withdraw from the study before completion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07557875 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Ankyloglossia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07557875 currently recruiting?
Yes, NCT07557875 is actively recruiting participants. Contact the research team at phonglam@ump.edu.vn for enrollment information.
Where is the NCT07557875 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT07557875 clinical trial?
NCT07557875 is sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 53 participants.