Overview
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.
Description
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):
- Group 1 (Laser Group): Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase) with a power of 1W (average) and 2W (peak) in pulsed mode (CP2).
- Group 2 (Electrosurgery Group): Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C) in continuous contact mode.
Surgical Procedure: Both groups follow a standardized surgical protocol:
- Anesthesia: Local anesthesia with 2% Lidocaine/Adrenaline (0.45 ml).
- Technique: Transverse incision without suturing or muscle dissection to release the lingual frenum.
- Safety Measures: Use of protective eyewear for the laser group and electrode grounding pads for the electrosurgery group.
Data Collection and Blinding:
- Blinding: This is a single-blind study where the participants and their guardians are unaware of the assigned treatment group. The evaluator measuring post-operative outcomes is also blinded to the surgical method used.
- Follow-up Schedule: Evaluations are conducted at five specific intervals:
- Baseline (T0): Pre-operative measurements.
- Post-operative: At 24 hours (T1), 3 days (T2), 1 week (T3), and 1 month (T4).
Evaluation Criteria:
- Wound Healing: Assessed by the Early Wound Healing Score (EHS), focusing on re-epithelialization (CSR), haemostasis (CSH), and inflammation (CSI).
- Pain Intensity: Self-reported by patients using the Wong-Baker FACES Pain Rating Scale.
- Tongue Function: Measuring the increase in free tongue length (mm) using a Quick Tongue-Tie (QTT) tool.
Eligibility
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.
