Healing Efficacy of Diode Laser in Lingual Frenectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lingual Frenectomy using 940nm Diode Laser
- Lingual Frenectomy using High-frequency Electrosurgery
Treatment groups
53 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov