Simplified Versus Conventional Technique for Complete Denture Fabrication.
7 de enero de 2016 actualizado por: Ana Luísa de Barros Pascoal, Universidade Federal do Rio Grande do Norte
Quality of Life, Patient Satisfaction, Quality of Dentures, Masticatory Efficiency, Presence of Temporomandibular Dysfunction and Costs Analysis of Simplified and Conventional Techniques for Complete Denture Fabrication
The purpose of this study is to evaluate the effectiveness of a simplified technique of conventional dentures fabrication, comparing it to a traditional technique, by evaluating the impact of oral health on quality of life, satisfaction of individuals and chewing efficiency as well assessing the quality of prosthetics and TMD.
Furthermore, the cost involved in the manufacture of dentures through technique simplified will be compared to the cost involved in the traditional technique.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The traditional technique will be conducted through a protocol used by most dental schools in Brazil and described in some clinical trials as a conventional technique for dentures fabrication.
On simplified technical functional molding step is deleted, and thus the orientation planes are made directly on the resulting models of the initial molding alginate, and the mounting of the models is performed in semiadjustable articulators random with the aid of an auxiliary table 15 degrees with semiadjustable articulators fixed to the slope.
To evaluate the impact on oral health quality of life of individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent) for evaluation of patient satisfaction will use a specific questionnaire assessing the quality of the prostheses will be carried out through a specific exam, to assess the presence of TMD, all subjects will be evaluated through the RDC / TMD, for assessing the efficiency masticatory chewing capsules are used, the costs involved in the manufacture of prostheses will be calculated according to the material consumption used during the making of the prosthesis.
All subjects will be assessed before making the prostheses and 90 days after installation of new dentures during this period will be held regular control visits.
The data will be evaluated in order descriptive by numbers and proportions, moreover, it will be statistically evaluated by means of suitable tests.
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
Fase
- Fase 2
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
35 años a 95 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.
Exclusion Criteria:
Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.
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 |
|---|---|
|
Comparador activo: Complete conventional dentures
Complete dentures fabricated by conventional technique.
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The typical operations of conventional technique will be carried out dentures fabrication and clinical appointments and laboratory steps will be necessary until denture insertion: Preliminary impression using irreversible hydrocolloid in a stock trays; Individual acrylic resin trays fabrication; Functional impressions using Zinc oxide-eugenol paste and low fusion compound in a individual acrylic resin trays; Maxillary occlusion rims fabrication; Maxillary occlusion rims fabrication adjustments, Centric relation records and transference of the maxillary occlusion rims positions to semiadjustable articulators using a facebow; Setting of teeth in wax; Complete denture wax try-in; Insertion, instructions and postinsertion appointments.
Otros nombres:
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Comparador activo: Complete simplified dentures
Complete dentures fabricated by simplified technique
|
For a complete simplified denture fabrication, individual acrylic resin trays fabrication and functional impressions steps will be deleted, and the facebow for transference of the maxillary occlusion rims positions to semiadjustable articulators will be replaced by the table Camper.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life
Periodo de tiempo: Baseline = day 0
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To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent).
The inventory shall be applied by a masked examiner.
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Baseline = day 0
|
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Patient satisfaction
Periodo de tiempo: Baseline = day 0
|
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
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Baseline = day 0
|
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Masticatory efficiency
Periodo de tiempo: Three months
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The evaluation of the masticatory efficiency will be conducted through chewing capsules.
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Three months
|
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Quality of life
Periodo de tiempo: Three months
|
To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent).
The inventory shall be applied by a masked examiner.
|
Three months
|
|
Patient satisfaction
Periodo de tiempo: Three month
|
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
|
Three month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Costs analysis
Periodo de tiempo: Baseline = day 0
|
Assessment of the costs involved in the dentures fabrication will be calculated according to the methodology applied by Takanashi et al. 2004.
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Baseline = day 0
|
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Quality of dentures
Periodo de tiempo: Three months
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Assessment of the technical quality of dentures will be done using an examination that analyzes 14 variables: Selection of artificial teeth; Arrangement of the anterior teeth; Interocclusal distance; Stability of the upper and lower prosthesis; Language space; Centric occlusion; Occlusion during the excursive movements; Retention of upper and lower dentures; Edge of the upper prosthesis extension; Edge of the lower prosthesis extension; facets; Positioning of the posterior teeth.
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Three months
|
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Temporomandibular dysfunction
Periodo de tiempo: Baseline = day 0
|
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
|
Baseline = day 0
|
|
Temporomandibular dysfunction
Periodo de tiempo: Three month
|
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
|
Three month
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Patricia dos Santos Calderon, Doctor, Universidade Federal do Rio Grande do Norte
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
1 de marzo de 2015
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
4 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
7 de enero de 2016
Publicado por primera vez (Estimar)
11 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de enero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
7 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Simplified versus conventional
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