EVACFAODMedico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments
CAD/CAM manufactured fixed unitary dental prostheses
+ Conventionally manufactured unitary dental prostheses
Caries Dentales+3
+ Enfermedades Estomatognáticas
+ Enfermedades de los Dientes
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2014
Fecha en la que se inscribió al primer participante.The medico-economic objective of this study is to assess an organizational innovation for patients treated at the hospital for dental substance loss. The intervention study is the availability of such information for the management of patients, not that of its systematic use. The economic evaluation of this innovation consists of several parts: 1. A costing study seeking to determine the costs of compensation for dental substance loss by conventional technique and CAD/CAM per patient ; 2. Evaluate the cost from an hospital perspective to substitute CAD/CAM to conventional dental treatment equipments; 3. To built a cost-effectiveness ratio comparing the conventional technique and the CAD/CAM on the criterion of proportions of effective restorations obtained . Assess the medical and medico-technical impact of prosthesis availability from CAD/CAM: Modifications of treatment plans (some indications of plastic fillings could shift toward CD/CAM restorations?) and/or their chronology (order of execution phases). The patient cohort is cared for in a hospital Department of Dentistry for oral rehabilitation. There is indication of at least a partial or total dental crown restoration either by conventional methods or by CAD/CAM (equipoise). Directly assessable elements are: at the individual restoration level: Effective restoration time between indication and effective restoration, quality of the restoration, number of clinical sessions required, unitary cost of the restoration at the patient level: compliance, overall duration of treatment, duration of the restoration phase, number of clinical sessions (global and restoration phase) , criteria of quality of life (OHIP, SF36), treatment costs (global and restoration phase) at the hospital level: number of patients cared for per unit of time, number of restorations, revenues, expenses Patients seeking dental restorations in one of the study centers an needing at least one fixed restoration feasible either by CAD/CAM or conventional means will be selected during their first consultation (excluding emergency consultations). Quality of life (QOL) indices are then recorded. Two treatment plans are then created, one using conventional means and another using CAD/CAM means as required ; those two plans may differ in steps order. The last treatment step where these plans are identical is the randomization point. The treatment plans are maintained during the pre-prosthetic phases of the treatment, and updated in case of intercurrent events. The patient is formally included at the randomization point, and the plan selected by the randomization is carried out. The resource consumptions entailed by the prosthetic steps are recorded. At the end of treatment, patient satisfaction and QOL indices are recorded. An identical record is made 6 months after the end of treatment. Further long-term follow-up of the patients included in this study is planned, but will be the object of another protocol.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 200 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion criteria : * The patient is cared for in a hospital department of Dentistry for oral rehabilitation. * The patient has a dental insurance plan * There is indication of at least a partial or total dental crown, either by conventional methods or by CAD/CAM ( equipoise clause) . * It is possible to follow the patient for at least 6 months ( mid-term outcome evaluation beyond the immediate outcome) * Assessment of the patient to this monitoring (formal informed consent is not required by French law for accepted procedures) Exclusion criteria : * mental , linguistic or legal impossibility of understanding the protocol or no consent to participation. * Follow-up impossible or doubtful * Contraindication whatsoever to any therapeutic that can be implemented: * bruxism and occlusion disorders requiring treatment ( mechanical stresses , ceramic contra-indicated ) * TMJ disorder (severe limitation of therapeutic options before resolution) * known intolerance to a dental material used in the study * Patients participating in another clinical trial that may have an impact on the oro-facial region (consultation with investigators in the other trial is required before selection and inclusion). Teeth: * Need for further prosthetic development (e. g. telescopic milled crown ) . * Extensive coronary reconstruction requiring de novo root anchorage (post-and-core)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Service d'Odontologie Hôpital Pitié salpêtrière
Paris, FranceAbrir Service d'Odontologie Hôpital Pitié salpêtrière en Google Maps