Clinical Investigation of Mandibular Implant Overdenture
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures.
Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Virginia
-
Richmond,, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion:
- Adult patient;
- Male or female;
- At least one year of previous conventional complete denture treatment history;
- Willing to accept the conditions of the study and informed consent freely given;
- Ability to participate for 6 years;
- Able to understand and respond to self-reporting measurement scales used in the study;
- Minimum 20-mm interarch distance at the estimated vertical dimension of occlusion;
- Adequate bone quality;
- Adequate bone quantity to accommodate minimally four 3.75-mm diameter by 7-mm long Brånemark implants.
Exclusion:
- Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement;
- History of drug or alcohol abuse;
- Excessive smoking (1+ pack/day);
- Uncontrolled systemic disease;
- Inability to undergo minor oral surgery because of health or personal reasons;
- Irradiated surgical site;
- Unrealistic expectations of the prosthodontic treatment outcome;
- Psychological or psychiatric conditions that could influence the subject's reaction to treatment;
- Acute or chronic TMD problems;
- pregnancy;
- Class II jaw relationship;
- Conventional dental treatment the treatment of choice.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: treatment modalities changed for comparison
All subjects experienced all treatment modalities being studied.
|
All overdenture treatment modalities were provided to each subject using a crossover design.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
Periodo de tiempo: 6 month and 12 month
|
6 month and 12 month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David R Burns, Virginia Commonwealth University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NIDCR-12204
- R01DE012204 (Subvención/contrato del NIH de EE. UU.)
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. .