An interventional study of Lingual Frenectomy using 940nm Diode Laser and Lingual Frenectomy using High-frequency Electrosurgery in Ankyloglossia and Tongue-tie, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 2 sites in Vietnam. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
Participant Allocation: Participants meeting the inclusion criteria (aged 3-6, diagnosed with Kotlow grade 3 or 4 ankyloglossia) are randomly assigned to one of two groups using a simple randomization method (drawing lots):
Surgical Procedure: Both groups follow a standardized surgical protocol:
Data Collection and Blinding:
Follow-up Schedule: Evaluations are conducted at five specific intervals:
Evaluation Criteria:
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's planned enrollment of 53 is below the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength.
Procedure: Lingual Frenectomy using 940nm Diode Laser
Patients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group.
Procedure: Lingual Frenectomy using High-frequency Electrosurgery
Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team.
Also known as: Diode Laser Frenectomy, Laser-assisted Frenotomy
Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital.
Also known as: Electrosurgical Frenectomy, Electrocautery Frenotomy
Early Wound Healing Score (EHS)
The EHS is used to evaluate the early healing of periodontal soft tissue wounds. It is the sum of three components: Clinical Signs of Re-epithelialization (CSR), Clinical Signs of Haemostasis (CSH), and Clinical Signs of Inflammation (CSI). The total score ranges from 0 to 10, where a higher score indicates better and faster wound healing (10 being perfect healing).
Time frame: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale
Patients self-assess their pain levels using a scale of 6 faces representing different pain intensities. Scores range from 0 (no pain) to 10 (worst possible pain), with increments of 2 (0, 2, 4, 6, 8, 10).
Time frame: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Level of Intraoperative Bleeding
Bleeding is assessed during the surgical procedure and categorized into 2 levels: Grade 1 (No bleeding) and Grade 2 (Bleeding present, requiring local haemostatic measures like gauze pressure or laser/electrosurgery coagulation).
Time frame: During the surgical procedure (T0)
Increase in Free Tongue Length
Measured as the distance (in mm) from the attachment of the lingual frenum on the ventral surface of the tongue to the tip of the tongue using a Quick Tongue-Tie (QTT) measurement tool.
Time frame: Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.
Plan to share: No — The individual participant data will not be shared to ensure absolute confidentiality for the pediatric patients and their families, as stated in the informed consent and study protocol approved by the Ethics Committee.
Started Oct 2024 (actual). Primary completion is estimated for Sep 2026, 23 months after the start.
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