Dental Caries Clinical Trial
— EVACFAODOfficial title:
Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments
Verified date | October 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The
current literature is weak and does not separate the medical results of these two techniques.
However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment,
improve service to the patient by reducing the time required for these restorations, and
possibly lower care costs.
The aim of the study is to compare immediate medical results and short-term prosthetic
restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic
impacts and organizational aspects.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | February 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
France | Service d'Odontologie Hôpital Pitié salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficiency (derived from differences in efficacy, safety and costs) | Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment. | 18 months | |
Secondary | observance (number of visits/number of necessary visits for treatment) | number of visits/number of necessary visits for treatment | 18 months | |
Secondary | patient satisfaction on the VAS scale | 18 months | ||
Secondary | quality of life measured by SF36 | 18 months | ||
Secondary | quality of life measured by OHIP14 | 18 months | ||
Secondary | occurrence of adverse effects | 18 months | ||
Secondary | Costs | Number of prosthetic treatment sessions + Total prosthetic sessions durations + Medical personal cost + Disposable or semi-disposable consumables + Hospital revenues (as recorded in hospital records) | 18 months |
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