Comparison of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following TMJ Surgery
Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This prospective, randomized, parallel-group clinical trial was conducted in patients who developed postoperative facial nerve dysfunction following open temporomandibular joint surgery. Eligible participants were randomly allocated in a 1:1 ratio to one of two active photobiomodulation treatment groups using a computer-generated block randomization sequence.
Participants assigned to the GRR Laser group received extraoral transcutaneous photobiomodulation using a dual-wavelength 650-nm and 904-nm laser/LED system. Participants assigned to the SiroLaser Advance Plus group received extraoral transcutaneous photobiomodulation using a 660-nm continuous-wave diode laser. In both groups, irradiation was applied along the anatomical projection of the clinically affected facial nerve branches on the operated side.
Photobiomodulation treatment was initiated on the first postoperative day. Treatment was administered daily during the first five postoperative days and every other day thereafter, for a total of 15 treatment sessions. Each treatment session lasted approximately 10 minutes.
Facial nerve function was evaluated on postoperative days 5, 7, 10, 30, and 60. Clinical assessments included the House-Brackmann Grading System and the Sunnybrook Facial Grading System. Patient-reported functional status and quality of life were assessed using the Facial Clinimetric Evaluation (FaCE) Scale. The first standardized outcome assessment was performed on postoperative day 5; therefore, this assessment represented the first standardized postoperative evaluation rather than a pretreatment baseline.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara
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Ankara, Ankara, Turquía (Türkiye)
- Ankara University Faculty of Dentistry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who underwent open temporomandibular joint surgery.
- Presence of clinically confirmed postoperative facial nerve dysfunction.
- Willingness to comply with the follow-up protocol and attend scheduled follow-up visits.
- Provision of written informed consent.
Exclusion Criteria:
- Pre-existing facial nerve paralysis or facial nerve dysfunction before surgery.
- History of central neurological disease.
- Previous surgery involving the facial nerve.
- History of head and neck malignancy and/or chemotherapy or radiotherapy that could potentially affect facial nerve function.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: SiroLaser Advance Plus Group
Participants received photobiomodulation using the SiroLaser Advance Plus system.
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Extraoral transcutaneous photobiomodulation was delivered using the SiroLaser Advance Plus system in SoftLase mode.
Irradiation was provided using a 660-nm continuous-wave diode laser with an output power of 25 mW through an 8-mm fiber-optic tip.
Treatment was applied along the anatomical projection of the clinically affected facial nerve branches.
Treatment began on the first postoperative day and consisted of 15 sessions using the same treatment schedule as the GRR Laser group.
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Experimental: GRR Laser Group
Participants received photobiomodulation using the GRR Laser system.
|
Extraoral transcutaneous photobiomodulation was delivered using the GRR Laser system, a dual-wavelength 650-nm and 904-nm laser/LED system.
Treatment was applied along the anatomical projection of the clinically affected facial nerve branches.
Treatment began on the first postoperative day and consisted of 15 sessions, administered daily during the first 5 postoperative days and every other day thereafter.
Each session lasted approximately 10 minutes.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sunnybrook Facial Grading System Score
Periodo de tiempo: From postoperative day 5 to postoperative day 60
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The Sunnybrook Facial Grading System was used to assess facial nerve function based on resting symmetry, voluntary facial movement, and synkinesis.
The composite score ranges from 0 to 100, with higher scores indicating better facial nerve function.
The change score was calculated as the postoperative day 60 score minus the postoperative day 5 score.
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From postoperative day 5 to postoperative day 60
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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House-Brackmann Grading System
Periodo de tiempo: Postoperative days 5, 7, 10, 30, and 60
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Facial nerve function was graded using the House-Brackmann Grading System, which classifies facial nerve function from Grade I (normal function) to Grade VI (complete paralysis), with higher grades indicating greater dysfunction.
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Postoperative days 5, 7, 10, 30, and 60
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Facial Clinimetric Evaluation (FaCE) Scale
Periodo de tiempo: Postoperative days 5, 7, 10, 30, and 60
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The FaCE Scale is a 15-item patient-reported measure assessing facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.
Total scores are transformed to a 0-100 scale, with higher scores indicating better facial function and quality of life.
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Postoperative days 5, 7, 10, 30, and 60
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mehmet Emre Yurttutan, DDS, PhD, Ankara University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AU-TMJ-PBM-2022
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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