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

Primary Purpose

Dental Caries, Tooth Fractures, Tooth Resorption

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CAD/CAM manufactured fixed unitary dental prostheses
Conventionally manufactured unitary dental prostheses
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Crowns, Inlays, Onlays

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Service d'Odontologie Hôpital Pitié salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

CAD/CAM manufactured fixed unitary dental prostheses

Conventionally manufactured unitary dental prostheses

Outcomes

Primary Outcome Measures

efficiency (derived from differences in efficacy, safety and costs)
Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.

Secondary Outcome Measures

observance (number of visits/number of necessary visits for treatment)
number of visits/number of necessary visits for treatment
patient satisfaction on the VAS scale
quality of life measured by SF36
quality of life measured by OHIP14
occurrence of adverse effects
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)

Full Information

First Posted
June 10, 2015
Last Updated
October 24, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02494427
Brief Title
Comparison of Conventional and CAD/CAM Dental Restorations
Acronym
EVACFAOD
Official Title
Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: A costing study seeking to determine the costs of compensation for dental substance loss by conventional technique and CAD/CAM per patient ; Evaluate the cost from an hospital perspective to substitute CAD/CAM to conventional dental treatment equipments; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Tooth Fractures, Tooth Resorption
Keywords
Crowns, Inlays, Onlays

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CAD/CAM manufactured fixed unitary dental prostheses
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventionally manufactured unitary dental prostheses
Intervention Type
Device
Intervention Name(s)
CAD/CAM manufactured fixed unitary dental prostheses
Intervention Type
Device
Intervention Name(s)
Conventionally manufactured unitary dental prostheses
Primary Outcome Measure Information:
Title
efficiency (derived from differences in efficacy, safety and costs)
Description
Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
observance (number of visits/number of necessary visits for treatment)
Description
number of visits/number of necessary visits for treatment
Time Frame
18 months
Title
patient satisfaction on the VAS scale
Time Frame
18 months
Title
quality of life measured by SF36
Time Frame
18 months
Title
quality of life measured by OHIP14
Time Frame
18 months
Title
occurrence of adverse effects
Time Frame
18 months
Title
Costs
Description
Number of prosthetic treatment sessions + Total prosthetic sessions durations + Medical personal cost + Disposable or semi-disposable consumables + Hospital revenues (as recorded in hospital records)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Azerad, DDS, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Odontologie Hôpital Pitié salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Conventional and CAD/CAM Dental Restorations

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