Healing Efficacy of Diode Laser in Lingual Frenectomy (NCT07557875) | Clinical Trial Compass
RecruitingNot Applicable
Healing Efficacy of Diode Laser in Lingual Frenectomy
Vietnam53 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Wound Healing Score (EHS)
Timeframe: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Trial details
NCT IDNCT07557875
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City