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
Carie dentaire+5
+ Maladies stomatognathiques
+ Maladies des dents
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2014
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.200 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Service d'Odontologie Hôpital Pitié salpêtrière
Paris, FranceOuvrir Service d'Odontologie Hôpital Pitié salpêtrière dans Google Maps