Healing Efficacy of Diode Laser in Lingual Frenectomy
22 de abril de 2026 actualizado por: Phong Dai Lam, University of Medicine and Pharmacy at Ho Chi Minh City
Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
53
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Phong Dai Lam, PhD, DDS
- Número de teléfono: (+84) 906312958
- Correo electrónico: phonglam@ump.edu.vn
Ubicaciones de estudio
-
-
-
Ho Chi Minh City, Vietnam
- Reclutamiento
- Children's Hospital 1, Department of Odonto-Stomatology
-
Contacto:
- Phung Van Ho, DDS
- Número de teléfono: (+84) 983791484
- Correo electrónico: hvphung.ckii.rhm23@ump.edu.vn
-
Investigador principal:
- Phung Van Ho, DDS
-
Sub-Investigador:
- Phong Dai Lam, PhD, DDS
-
Ho Chi Minh City, Vietnam
- Reclutamiento
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
-
Contacto:
- Phong Dai Lam, PhD, DDS
- Número de teléfono: (+84) 906312958
- Correo electrónico: phonglam@ump.edu.vn
-
Sub-Investigador:
- Phung Van Ho, DDS
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Diode Laser Group
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.
|
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.
Otros nombres:
|
|
Comparador activo: Electrosurgery Group
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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Early Wound Healing Score (EHS)
Periodo de tiempo: 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).
|
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: 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).
|
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
|
|
Level of Intraoperative Bleeding
Periodo de tiempo: 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).
|
During the surgical procedure (T0)
|
|
Increase in Free Tongue Length
Periodo de tiempo: 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.
|
Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2024
Finalización primaria (Estimado)
30 de septiembre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades Estomatognáticas
- Heridas y Lesiones
- Complicaciones Postoperatorias
- Procesos Patológicos
- Cambios de temperatura corporal
- Trastornos de estrés por calor
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Hipertermia
- Anquiloglosia
- Dolor Postoperatorio
- Equipos y suministros
- Láser
- Dispositivos ópticos
- Equipos y suministros de radiación
- Láseres, semiconductores
Otros números de identificación del estudio
- IRB00010293-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .