Skip to content

Comparison of Conventional and CAD/CAM Dental Restorations

Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494427
Acronym
EVACFAOD
Enrollment
200
Registered
2015-07-10
Start date
2014-02-28
Completion date
2018-02-28
Last updated
2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Tooth Fractures, Tooth Resorption

Keywords

Crowns, Inlays, Onlays

Brief summary

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.

Detailed description

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.

Interventions

DEVICECAD/CAM manufactured fixed unitary dental prostheses
DEVICEConventionally manufactured unitary dental prostheses

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
efficiency (derived from differences in efficacy, safety and costs)18 monthsDifferential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.

Secondary

MeasureTime frameDescription
patient satisfaction on the VAS scale18 months
quality of life measured by SF3618 months
observance (number of visits/number of necessary visits for treatment)18 monthsnumber of visits/number of necessary visits for treatment
occurrence of adverse effects18 months
Costs18 monthsNumber of prosthetic treatment sessions + Total prosthetic sessions durations + Medical personal cost + Disposable or semi-disposable consumables + Hospital revenues (as recorded in hospital records)
quality of life measured by OHIP1418 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026