Healing Efficacy of Diode Laser in Lingual Frenectomy

University of Medicine and Pharmacy at Ho Chi Minh City53 enrolled

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.

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.

Interventions

Lingual Frenectomy using 940nm Diode LaserPROCEDURE

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.

Lingual Frenectomy using High-frequency ElectrosurgeryPROCEDURE

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.