940 nm diode laser versus electrosurgery for tongue‑tie release in children aged 3–6
Official title: Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy
Run by University of Medicine and Pharmacy at Ho Chi Minh City · NCT07557875 · Data updated 2026-11-12
This trial will test whether a 940 nm diode laser or conventional electrosurgery leads to faster healing, less pain, and better tongue movement for children aged 3 to 6 with tongue‑tie.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 6 Years |
| Sex | All |
| Enrollment | 53 (estimated) |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City Academic / other |
| Locations | 2 sites (Ho Chi Minh City and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07557875 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–6 with Kotlow grade 3 or 4 ankyloglossia whose parents or legal guardians provide informed consent and can attend all follow‑up visits.
✕Probably not a fit
Children with allergies to local anesthetics, significant systemic medical or bleeding disorders, uncooperative behavior preventing local anesthesia, or those who cannot complete follow‑up are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children with Kotlow grade 3 or 4 ankyloglossia are randomly assigned to receive a lingual frenectomy with either a 940 nm diode laser (Epic X, Biolase; 1W average, 2W peak, pulsed CP2) or a high‑frequency electrosurgery unit (ERBE‑VIO 100C) in continuous contact mode. Procedures use standardized local anesthesia (2% lidocaine with adrenaline), a transverse incision without sutures, and group‑specific safety measures (protective eyewear for laser, grounding pads for electrosurgery). Outcomes measured at 24 hours, 3 days, 1 week, and 1 month include Early Wound Healing Score (EHS), Wong‑Baker FACES pain scores, intraoperative bleeding control, and free tongue length by Kotlow classification. The trial is single‑blind (participants/guardians and the blinded evaluator) with simple randomization by drawing lots.
Why it matters
Potential benefit: If successful, the diode laser could result in faster wound healing, less postoperative pain and bleeding, and quicker improvement in tongue mobility for young children.
How similar studies have gone: Previous small trials and case series of laser frenectomy have reported reduced bleeding, shorter procedure time, and less pain compared with scalpel or electrocautery, but results are mixed and larger randomized data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Children's Hospital 1, Department of Odonto-Stomatology
Ho Chi Minh City, Vietnam Recruiting -
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam Recruiting
Study contacts
- Study coordinator: Phong Dai Lam, PhD, DDS
- Email: phonglam@ump.edu.vn
- Phone: (+84) 906312958
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.