Comparison of Conventional and CAD/CAM Dental Restorations (EVACFAOD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Tooth Resorption; Tooth Fractures
• Intervention / Treatment: Device: CAD/CAM manufactured fixed unitary dental prostheses; Device: Conventionally manufactured unitary dental prostheses

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service d'Odontologie Hôpital Pitié salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CAD/CAM manufactured fixed unitary dental prostheses	Device: CAD/CAM manufactured fixed unitary dental prostheses
Active Comparator: 2; Conventionally manufactured unitary dental prostheses	Device: Conventionally manufactured unitary dental prostheses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
observance (number of visits/number of necessary visits for treatment)	number of visits/number of necessary visits for treatment	18 months
patient satisfaction on the VAS scale		18 months
quality of life measured by SF36		18 months
quality of life measured by OHIP14		18 months
occurrence of adverse effects		18 months
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jean Azerad, DDS, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Crowns; Inlays; Onlays
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Tooth Injuries; Dental Caries; Tooth Fractures; Tooth Resorption
• Other Study ID Numbers: K110104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No