Dental CariesEVACFAODNCT02494427
Comparison of Conventional and CAD/CAM Dental Restorations
A study testing CAD/CAM manufactured fixed unitary dental prostheses and Conventionally manufactured unitary dental prostheses in people with Dental Caries and Tooth Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries, Tooth Fractures, Tooth Resorption
- What is being tested?
- CAD/CAM manufactured fixed unitary dental prostheses and Conventionally manufactured unitary dental prostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries, Tooth Fractures, Tooth Resorption
- Being tested
- CAD/CAM manufactured fixed unitary dental prostheses, Conventionally manufactured unitary dental prostheses
- Keywords
- Crowns, Inlays, Onlays
- Medical subject headings
- Dental Caries, Tooth Fractures, Tooth Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM manufactured fixed unitary dental prosthesesDevice
Conventionally manufactured unitary dental prosthesesDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CAD/CAM manufactured fixed unitary dental prostheses Receives: Device: CAD/CAM manufactured fixed unitary dental prostheses |
| 2 | Active comparator | Conventionally manufactured unitary dental prostheses Receives: Device: Conventionally manufactured unitary dental prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency (derived from differences in efficacy, safety and costs)
Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.
Measured: 18 months
Secondary outcomes (6)
observance (number of visits/number of necessary visits for treatment)
number of visits/number of necessary visits for treatment
Measured: 18 months
patient satisfaction on the VAS scale
Measured: 18 months
quality of life measured by SF36
Measured: 18 months
quality of life measured by OHIP14
Measured: 18 months
occurrence of adverse effects
Measured: 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)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2017
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Azerad, DDS, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494427
- Sponsor's protocol ID
- K110104
- Acronym
- EVACFAOD
- Status last verified
- Oct 2017
- First submitted
- 10 Jun 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments
- ClinicalTrials.gov ID
- NCT02494427
- Acronym / sponsor ID
- EVACFAOD / K110104
- Conditions
- Dental Caries, Tooth Fractures, Tooth Resorption
- Keywords
- Crowns, Inlays, Onlays
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2018 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CAD/CAM manufactured fixed unitary dental prosthesesCAD/CAM manufactured fixed unitary dental prostheses |
| 2 | Active comparator | Device: Conventionally manufactured unitary dental prosthesesConventionally manufactured unitary dental prostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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:
- 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).
- Need for further prosthetic development (e. g. telescopic milled crown ) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD/CAM manufactured fixed unitary dental prostheses | Device | 1 |
| Conventionally manufactured unitary dental prostheses | Device | 2 |
Primary outcome
efficiency (derived from differences in efficacy, safety and costs)
Time frame: 18 months
Differential efficiency (derived from differences in efficacy, safety and costs) at end of treatment.
6 secondary outcomes
observance (number of visits/number of necessary visits for treatment)
Time frame: 18 months
patient satisfaction on the VAS scale
Time frame: 18 months
quality of life measured by SF36
Time frame: 18 months
quality of life measured by OHIP14
Time frame: 18 months
occurrence of adverse effects
Time frame: 18 months
Costs
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Azerad, DDS, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM manufactured fixed unitary dental prostheses and Conventionally manufactured unitary dental prostheses in people with Dental Caries and Tooth Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency (derived from differences in efficacy, safety and costs) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.