Ankyloglossia, Tongue-tie
Conditions
Keywords
Ankyloglossia, Tongue-tie, Lingual frenectomy, Diode laser, Electrosurgery, Wound healing, Postoperative pain, Early Wound Healing Score (EHS), Wong-Baker FACES Pain Rating Scale, Kotlow's classification
Brief 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.
Detailed 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.
Interventions
PROCEDURELingual Frenectomy using 940nm Diode Laser
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.
PROCEDURELingual Frenectomy using High-frequency Electrosurgery
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The study is designed as a single-blind trial to minimize bias in outcome assessment. The masking procedures are implemented as follows: * Participants and Legal Guardians: To maintain masking, the surgical procedures are performed under similar clinical settings. The specific equipment (Diode Laser or Electrosurgical unit) is not disclosed to the children or their parents before, during, or after the procedure. * Outcomes Assessor: A dedicated evaluator, who is responsible for measuring the free tongue length, assessing pain levels via the Wong-Baker scale, and calculating the Early Wound Healing Score (EHS), is strictly masked to the treatment allocation. This assessor is not present during the surgery and only performs evaluations at scheduled follow-up intervals. * Data Analyst: The individuals involved in the statistical analysis will process the data using coded group identifiers (e.g., Group 1 and Group 2) without knowledge of which code corresponds to the laser or electrosurger
Intervention model description
The study utilizes a parallel-group, randomized clinical trial design with a 1:1 allocation ratio. Participants are assigned to either the experimental group or the control group using a simple randomization method (drawing lots). * Randomization: A total of 50 lots are prepared, divided into two equal sets marked with numbers "1" and "2". Each participant draws one lot to determine their treatment group. * Allocation: Group 1 (Experimental): Participants who draw lot "1" undergo lingual frenectomy using a 940 nm diode laser. Group 2 (Control): Participants who draw lot "2" undergo the procedure using high-frequency electrosurgery. * Blinding: This is a single-blind study. Participants and their legal guardians are blinded to the assigned surgical method. To ensure objective results, the outcome evaluator is also blinded to the participant's treatment group.
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Wound Healing Score (EHS) | 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale | 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery. | 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). |
| Level of Intraoperative Bleeding | During the surgical procedure (T0) | 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). |
| Increase in Free Tongue Length | Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery. | 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. |
Countries
Vietnam
Contacts
CONTACTPhong Dai Lam, PhD, DDS
Outcome results
None listed