Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder
9 de septiembre de 2015 actualizado por: Simone Saldanha Ignacio de Oliveira, University of Sao Paulo
Evaluation of Postural Balance in Individuals With Temporomandibular Disorder by Means of Force Platform After Using Occlusal Stabilizer Splint Disorder
To investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
The research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and magnetic resonance imaging of the temporomandibular joints.
The research is a randomized, controlled, prospective clinical study with intervention.
Postural equilibrium will be evaluated by means of a force plate.
In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises.
After 12 weeks, the groups were re-evaluated.
The results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of 0.05.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
approved 06/29/2011
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- Fase 3
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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São Paulo/SP
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São Paulo, São Paulo/SP, Brasil, 05508-900
- Universidade de Sao Paulo
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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
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnostic Criteria Temporomandibular Disorders and dentate subjects
Exclusion Criteria:
- Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: therapeutic exercises
13 as control group - The control group got only orientation related to therapeutic exercises.The orientation for therapeutic exercises seek to correctly position the jaw in the resting position.
Maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
|
The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
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Experimental: occlusal plate group
36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria.
The patients also received therapeutic exercises too.
The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
|
The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
In the plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day. The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
Periodo de tiempo: twelve weeks
|
Postural equilibrium was evaluated by means of a force plate.
In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation related to therapeutic exercises.
|
twelve weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Simone de Oliveira, PHD, University of Sao Paulo
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
1 de julio de 2011
Finalización primaria (Actual)
1 de diciembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
6 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de septiembre de 2014
Publicado por primera vez (Estimar)
26 de septiembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de septiembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2015
Última verificación
1 de septiembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Enfermedades Estomatognáticas
- Enfermedades de la mandíbula
- Trastornos Craneomandibulares
- Enfermedades mandibulares
- Síndromes de dolor miofascial
- Enfermedad
- Trastornos de la articulación temporomandibular
- Síndrome de disfunción de la articulación temporomandibular
- Agentes antiinfecciosos
- Agentes dermatológicos
- Agentes antifúngicos
- Agentes queratolíticos
- Ácido salicílico
Otros números de identificación del estudio
- Postural balance
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