Ankyloglossia (tongue-tie): a diagnostic and treatment quandary.
L A Kotlow
https://pubmed.ncbi.nlm.nih.gov/10635253Actively Recruiting
Phase Not Applicable
Age: 3Years - 6Years
All Genders
ID07557875
Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy for Children With Ankyloglossia
Led by University of Medicine and Pharmacy at Ho Chi Minh City · Updated on 2026-04-30
53
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for treating tongue-tie (ankyloglossia) in children aged 3 to 6 years. The study evaluates the healing process and post-surgery experiences, focusing on wound healing, pain levels, bleeding control, and tongue mobility. It aims to find out if the 940 nm diode laser technique offers better results than traditional electrosurgery. Participants are randomly assigned to one of two groups: one undergoes lingual frenectomy using a 940 nm diode laser with specific power settings in pulsed mode, and the other group receives the procedure using a high-frequency electrosurgical unit. Both procedures use a transverse incision without suturing, with local anesthesia administered. Safety measures include protective eyewear for the laser group and grounding pads for the electrosurgery group. Children and their guardians will attend follow-up visits at 24 hours, 3 days, 1 week, and 1 month after surgery for assessments. These include measuring wound healing using the Early Wound Healing Score, pain intensity with the Wong-Baker FACES Pain Rating Scale, bleeding during surgery, and tongue mobility by measuring free tongue length. The study is designed to keep participants and evaluators unaware of the assigned treatment to ensure unbiased results.
CONDITIONS
Brief Title
Healing Efficacy of Diode Laser in Lingual Frenectomy
Who Can Participate
Age: 3Years - 6Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged between 3 and 6 years
- Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification
- Parents or legal guardians provide informed consent for participation
- Patients and guardians agree to follow the follow-up schedule at 24 hours, 3 days, 1 week, and 1 month post-surgery
You will not qualify if you...
- History of allergy to local anesthetics such as Lidocaine or Adrenaline
- Presence of systemic diseases or high-risk surgical factors like cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma
- Uncooperative patients unable to undergo procedure under local anesthesia or follow post-operative instructions
- Patients who withdraw from the study before completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo lingual frenectomy using either a 940 nm diode laser or a high-frequency electrosurgical unit. The procedure involves a transverse incision without suturing, performed under local anesthesia.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 1 month
Participants are evaluated post-surgery for wound healing, pain intensity, and tongue function at multiple intervals to monitor recovery and treatment effects.
4 visits at 24 hours, 3 days, 1 week, and 1 month post-surgery (in-person)
Trial Site Locations
Total: 2 locations
1
Children's Hospital 1, Department of Odonto-Stomatology
Ho Chi Minh City, Vietnam
Actively Recruiting
2
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
Actively Recruiting
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Research Team
P
Phong Dai Lam, PhD, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35807068