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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07677228
Telerehabilitation Versus Home-Based Jaw Exercises in Temporomandibular Disorder With Bruxism (TELEROC)
24 de junio de 2026 actualizado por: Mehmet Turgut
Effectiveness of Telerehabilitation-Based Rocabado Exercises Compared With Home-Based Rocabado Exercises in Patients With Myofascial Temporomandibular Dysfunction Accompanied by Bruxism: A Randomised Controlled Trial
This study looked at whether jaw exercises (the Rocabado exercise programme) work better when delivered through supervised online video sessions than when done at home with written instructions alone, in adults who have jaw-joint pain (temporomandibular disorder) together with teeth grinding (bruxism).
Thirty adults were randomly placed into one of two groups.
Both groups were taught the same exercises and asked to do them twice a day for four weeks.
One group also took part in supervised video sessions three times a week, where a physiotherapist watched their exercises and gave feedback; the other group used printed exercise leaflets with weekly text-message reminders.
The researchers measured jaw pain, how wide participants could open their mouth, jaw movement, stress, sleep quality and oral habits before treatment, after two weeks and after four weeks, to see which approach gave better results.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This single-centre, parallel-group, randomised controlled trial was conducted at the Faculty of Dentistry, Nevşehir Hacı Bektaş Veli University.
Participants who met the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myofascial temporomandibular disorder with concurrent bruxism were randomly allocated in a 1:1 ratio using a computer-generated simple randomisation sequence.
Allocation was concealed using sequentially numbered, opaque, sealed envelopes that were opened only after enrolment.
The outcome assessor was blinded to group allocation; participants were not blinded owing to the nature of the intervention.
Both groups received identical initial face-to-face training in the Rocabado 6×6 exercise programme and were instructed to perform the exercises twice daily for four weeks.
The telerehabilitation group additionally received supervised video sessions, whereas the comparator group followed the programme at home with printed materials and reminders only.
Assessments were performed in person at baseline, at week 2 (mid-treatment) and at week 4 (post-treatment).
The sample size was estimated using G*Power, and data were analysed with within-group and between-group statistical comparisons.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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.
Ubicaciones de estudio
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Nevşehir Province
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Nevşehir, Nevşehir Province, Turquía (Türkiye), 50300
- Nevşehir Hacı Bektaş Veli University, Faculty of Dentistry
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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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adults aged 18-60 years
- Diagnosis of myofascial temporomandibular disorder (TMD) with bruxism according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- Visual Analogue Scale (VAS) pain score ≥ 3
- No medical treatment for TMD in the preceding 6 months
- Access to a smartphone with internet connectivity
- Turkish literacy and communication ability
Exclusion Criteria:
- Active orthodontic or splint treatment
- History of temporomandibular joint surgery
- Systemic inflammatory disease
- Pregnancy
- Major psychiatric disorders
- Neurological deficits in the cervical region
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Telerehabilitation group
Participants received supervised Rocabado 6×6 exercise training through video sessions delivered via WhatsApp three times per week, with real-time physiotherapist feedback, in addition to performing the Rocabado exercises at home twice daily for four weeks.
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Supervised Rocabado 6×6 exercise programme delivered through video sessions via WhatsApp three times per week, with real-time physiotherapist feedback on exercise performance and technique, performed in addition to twice-daily home Rocabado exercises for four weeks.
|
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Comparador activo: Home exercise group
Participants performed the same Rocabado 6×6 exercise programme at home twice daily for four weeks, supported by printed exercise brochures and weekly SMS reminders, without supervised video sessions.
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Rocabado 6×6 exercise programme performed at home twice daily for four weeks, supported by printed exercise brochures and weekly SMS reminders, without supervised video sessions or physiotherapist feedback.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain intensity (Visual Analogue Scale)
Periodo de tiempo: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
Pain intensity assessed using the Visual Analogue Scale (VAS), scored from 0 to 10 cm, for morning pain, pain during chewing (mastication) and night pain.
Higher scores indicate greater pain.
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Maximum mouth opening
Periodo de tiempo: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Maximum mouth opening measured in millimetres using a digital calliper (Mitutoyo, Japan); the mean of three consecutive measurements was recorded.
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Temporomandibular joint range of motion
Periodo de tiempo: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
Active and passive maximum mouth opening, right and left lateral movements, and protrusion measured in millimetres using a digital calliper (Mitutoyo, Japan).
|
Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
|
TMD severity (Fonseca Anamnestic Index)
Periodo de tiempo: Baseline and week 4 (post-treatment)
|
Severity of temporomandibular disorder assessed using the Fonseca Anamnestic Index (0-100 points); higher scores indicate greater severity.
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Baseline and week 4 (post-treatment)
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Perceived stress (Perceived Stress Scale)
Periodo de tiempo: Baseline and week 4 (post-treatment)
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Perceived stress assessed using the Perceived Stress Scale (PSS-14), scored from 0 to 40; higher scores indicate greater perceived stress.
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Baseline and week 4 (post-treatment)
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Sleep quality (Jenkins Sleep Scale)
Periodo de tiempo: Baseline and week 4 (post-treatment)
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Sleep quality assessed using the Jenkins Sleep Scale, scored from 0 to 20; higher scores indicate poorer sleep quality.
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Baseline and week 4 (post-treatment)
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Oral parafunctional habits (Oral Behaviours Checklist)
Periodo de tiempo: Baseline and week 4 (post-treatment)
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Oral parafunctional habits assessed using the Oral Behaviours Checklist (OBC), scored from 0 to 40; higher scores indicate more frequent oral parafunctional behaviours.
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Baseline and week 4 (post-treatment)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Nevin Ergun, Sanko University
- Investigador principal: Taha Turgut, Msc. PT., Nevşehir Hacı Bektaş Veli University
- Investigador principal: Mehmet Turgut, Nevsehir Haci Bektas Veli University
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
- Turgut T. Effectiveness of telerehabilitation-based Rocabado exercises compared to home-based Rocabado exercises in myofascial temporomandibular dysfunctions accompanied by bruxism [master's thesis]. Nevşehir: Nevşehir Hacı Bektaş Veli University; 2024.
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)
15 de diciembre de 2023
Finalización primaria (Actual)
20 de julio de 2024
Finalización del estudio (Actual)
20 de julio de 2024
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2026
Publicado por primera vez (Actual)
30 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades Musculares
- Enfermedades Articulares
- Enfermedades de la mandíbula
- Enfermedades de los dientes
- Enfermedades mandibulares
- Trastornos Craneomandibulares
- Comportamiento
- Hábitos
- Bruxismo
- Trastornos de la articulación temporomandibular
Otros números de identificación del estudio
- 2300080935
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data are not made publicly available.
De-identified data generated and analysed during the study are available from the corresponding author on reasonable request, subject to institutional and ethical approval.
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. .