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Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism

28 de abril de 2026 actualizado por: Kübra Kendal, Okan University

Comparison of the Effects of Different Massage Techniques on Pain, Orofacial Muscle Characteristics, Disability, and Sleep Quality in Individuals With Bruxism

The aim of this study is to compare the effects of occlusal splint therapy and different massage techniques on pain intensity and orofacial muscle tone and stiffness in individuals with possible sleep bruxism. A secondary aim is to evaluate the effects of these interventions on oral parafunctional behaviors, disability, and sleep quality.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

Individuals meeting the inclusion criteria will be randomly assigned to three groups using block randomization: classic massage group (CM), connective tissue massage group (CTM), and occlusal splint group (OCG). Following their assessments, individuals will be assigned to their respective groups. The CM and CTM groups will receive different massage techniques twice a week from a physiotherapist for four weeks, while the OCG group will be instructed to use a custom-made occlusal splint provided by a dentist for four weeks. Assessments will be repeated for all individuals at the 4th and 8th weeks.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

42

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

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:

  • Possible diagnosis of sleep bruxism,
  • Reporting jaw or chewing muscle pain within the last 3 months

Exclusion Criteria:

  • Having any orthopedic, neurological, or psychiatric diagnosis,
  • Having systemic and/or degenerative disorders,
  • Neurological or psychiatric disorders (excluding anxiety and depression),
  • Using medications that affect sleep or motor behavior,
  • Having arthrogenic or mixed temporomandibular disorders,
  • Using an intraoral prosthesis,
  • Having a history of direct trauma or previous surgery in the orofacial region,
  • Using muscle relaxants and non-steroidal anti-inflammatory drugs,
  • Using a removable prosthesis,
  • Receiving any treatment for bruxism within the last 4 weeks.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Classical Massage Group (CM)
The classic massage treatment will be planned to include superficial and deep manual techniques targeting the facial and chewing muscles. Prior to the treatment, the individual will be positioned supine in a comfortable position. The massage protocol will include effleurage (superficial stroking), petrissage (kneading), friction (circular deep pressure), and gentle vibration techniques. The application will be performed bilaterally, targeting the masseter, temporalis, buccinator, and perioral muscle groups. Pressure intensity will be adjusted according to the individual's tolerance, avoiding pain provocation. Each session will last approximately 30 minutes and will be performed twice a week for a total of 4 weeks.
The classic massage treatment will be planned to include superficial and deep manual techniques targeting the facial and chewing muscles. Prior to the treatment, the individual will be positioned supine in a comfortable position. The massage protocol will include effleurage (superficial stroking), petrissage (kneading), friction (circular deep pressure), and gentle vibration techniques. The application will be performed bilaterally, targeting the masseter, temporalis, buccinator, and perioral muscle groups. Pressure intensity will be adjusted according to the individual's tolerance, avoiding pain provocation. Each session will last approximately 30 minutes and will be performed twice a week for a total of 4 weeks.
Comparador activo: Connective Tissue Massage Group (CMM)
Connective tissue massage will be planned to include reflex-activated manual techniques targeting the subcutaneous connective tissue in the face and mandibular region. The individual will be positioned supine, and the application will be performed using specific skin-tightening maneuvers that create gliding between the skin and subcutaneous tissues. The techniques will focus particularly on connective tissue areas around the masseter, temporalis, and mandibular ramus. During the application, slow and controlled maneuvers aimed at creating tension in the connective tissue rather than deep mechanical pressure will be preferred. Each session will last approximately 30 minutes and will be applied twice a week for a total of 4 weeks.
Connective tissue massage will be planned to include reflex-activated manual techniques targeting the subcutaneous connective tissue in the face and mandibular region. The individual will be positioned supine, and the application will be performed using specific skin-tightening maneuvers that create gliding between the skin and subcutaneous tissues. The techniques will focus particularly on connective tissue areas around the masseter, temporalis, and mandibular ramus. During the application, slow and controlled maneuvers aimed at creating tension in the connective tissue rather than deep mechanical pressure will be preferred. Each session will last approximately 30 minutes and will be applied twice a week for a total of 4 weeks.
Comparador activo: Occlusal Splint Group (OS)
Individuals in the OS group will have an occlusal splint fitted by the dental department and will be provided with guidance on lifestyle changes to be considered in daily living activities. Following a clinical examination by the dentist, an impression will be taken of each volunteer's upper dental arch using irreversible hydrocolloid and used to prepare a maxillary Michigan type occlusal splint. Volunteers will be instructed to wear the splint while sleeping and the necessary adjustments will be made by the same dentist after two weeks.
Individuals in the OS group will have an occlusal splint fitted by the dental department and will be provided with guidance on lifestyle changes to be considered in daily living activities. Following a clinical examination by the dentist, an impression will be taken of each volunteer's upper dental arch using irreversible hydrocolloid and used to prepare a maxillary Michigan type occlusal splint. Volunteers will be instructed to wear the splint while sleeping and the necessary adjustments will be made by the same dentist after two weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Analog Scale (VAS)
Periodo de tiempo: Before intervention, 4th week and 8th week after intervention
The VAS is a widely validated and reliable measurement tool developed to quantitatively assess an individual's perception of pain. It is typically designed as a straight line approximately 10 cm long; the left end of the line represents "no pain," and the right end represents "very severe/unbearable pain." Participants indicate the pain they feel by marking a point on the line as they see fit. The value obtained by measuring the marked point numerically expresses the individual's pain level. This scale was chosen for this study due to its ease of application, sensitivity, and widespread acceptance in clinical and research settings.
Before intervention, 4th week and 8th week after intervention
Analysis of Jaw Muscle Tone and Stiffness
Periodo de tiempo: Before intervention, 4th week and 8th week after intervention
Using the Myoton Pro device, physical characteristics such as tone (F) and stiffness (S) of the upper trapezius, sternocleidomastoid, and masseter muscles will be measured. These measurements will help determine the adaptations that bruxism creates in the soft tissues.
Before intervention, 4th week and 8th week after intervention
Oral Habits
Periodo de tiempo: Before intervention, 4th week and 8th week after intervention
The 21-item Oral Habits Checklist (OHAC) will be used to assess participants' oral parafunctional behaviors. The questionnaire, which asks about the frequency of parafunctional habits such as teeth clenching, teeth grinding, nail biting, lip biting, cheek biting, pen chewing, and gum chewing in the past month, will be answered using a 4-point Likert scale.
Before intervention, 4th week and 8th week after intervention
Jaw Functional Restriction
Periodo de tiempo: Before intervention, 4th week and 8th week after intervention
The 'Jaw Functional Restriction Scale-8' (CFRS) will be used for functional assessment. Individuals will be asked to determine their level of restriction for each of the 8 items on the scale within the last month. Individuals will be informed that on a 10 cm horizontal line, the number '0' represents 'no restriction' and the number '10' represents 'severe restriction'. The average of the individual's answers will be taken to calculate the functional restriction.
Before intervention, 4th week and 8th week after intervention
Sleep Quality
Periodo de tiempo: Before intervention, 4th week and 8th week after intervention
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. PSQI items are structured based on clinical observations of individuals with sleep disorders, existing sleep quality scales referenced in the literature, and 18-month clinical follow-up findings focusing on the PSQI.
Before intervention, 4th week and 8th week after intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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 (Estimado)

1 de mayo de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IstanbulOkanUnive

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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