Healing Efficacy of Diode Laser in Lingual Frenectomy

Официальное название

Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Lingual 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.
• Процедура Lingual 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.

Первичные конечные точки

• Early Wound Healing Score (EHS) [Срок оценки: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.]

Вторичные конечные точки (3)

• Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale [Срок оценки: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.]
• Level of Intraoperative Bleeding [Срок оценки: During the surgical procedure (T0)]
• Increase in Free Tongue Length [Срок оценки: Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 2 центра

• Children's Hospital 1, Department of Odonto-Stomatology — Ho Chi Minh City
• Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Публикации

• Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62. PMID 10635253
• Hwang WB, Kim DJ, Oh GS, Park JH. Aryl Hydrocarbon Receptor Ligands Indoxyl 3-sulfate and Indole-3-carbinol Inhibit FMS-like Tyrosine Kinase 3 Ligand-induced Bone Marrow-derived plasmacytoid Dendritic Cell Differentiation. Immune Netw. 2018 Oct 23;18(5):e35. doi: 10.4110/in.2018.18.e35. eCollection 2018 Oct. PMID 30402330
• Mazzoni A, Navarro RS, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT, Silva T, Santos EM, Sobral APT, Junior AB, Nammour S, Motta LJ, Bussadori SK. Comparison of the Effects of High-Power Diode Laser and Electrocautery for Lingual Frenectomy in Infants: A Blinded Randomized Controlled Clinical Trial. J Clin Med. 2022 Jun 30;11(13):3783. doi: 10.3390/jcm11133783. PMID 35807068

Идентификаторы

NCT: NCT07557875 · IRB00010293-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗