Photobiomodulation in Temporomandibular Disorder
28 de marzo de 2018 actualizado por: Lara Jansiski Motta, University of Nove de Julho
Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Temporomandibular disorder (TMD) affects a significant portion of the population.
Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults.
The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals.
The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD.
The study will be conducted at the Odontological Clinic of Universidade Nove de Julho.
It is a prospective trial of clinical and economic analysis.
It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo).
The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment.
The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied.
The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
45
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
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brasil, 18130 430
- Reclutamiento
- Lara Motta
-
Contacto:
- Lara Motta, PhD
- Número de teléfono: 5511998829511
- Correo electrónico: larajmotta@terra.com.br
-
-
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
15 años a 25 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- people between 15 and 25 years
- diagnosis of TMD in group I
Exclusion Criteria:
- Individuals with dental-facial anomalies
- orthodontic or orthopedic treatment
- Individuals who were taking muscle relaxants or anti-inflammatory medications
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Low-intensity laser
Twelve laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2, in accordance with the protocol suggested by Venezian et al. (2010) and Carvalho et al. (2010).
The laser will be applied to 3 points of the masseter muscle (upper, middle, and lower bundles) and 1 point in the anterior temporalis on each side of the face
|
Laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
|
Comparador activo: Occlusal Plate
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
|
Comparador de placebos: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain
Periodo de tiempo: 12 months after treatment
|
Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders
|
12 months after treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost-effectviness
Periodo de tiempo: 12 months after treatment
|
This phase of the study will consist in the quantification of resources, i.e. determining the frequency of use of resources and materials during the treatment.
The units used to quantify the direct costs consumed are physical units such as consultation time, number of sessions, equipment used, and materials consumed.
These data will be collected using a specific form.
|
12 months after treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
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)
10 de octubre de 2017
Finalización primaria (Actual)
21 de enero de 2018
Finalización del estudio (Anticipado)
10 de octubre de 2018
Fechas de registro del estudio
Enviado por primera vez
9 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de marzo de 2017
Publicado por primera vez (Actual)
30 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
28 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Enfermedades Estomatognáticas
- Enfermedades de la mandíbula
- Trastornos Craneomandibulares
- Enfermedades mandibulares
- Síndromes de dolor miofascial
- 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
- CEPhotobio01
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. .