NCT02494427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

June 10, 2015

Last Update Submit

October 24, 2017

Conditions

Dental CariesTooth FracturesTooth Resorption

Keywords

CrownsInlaysOnlays

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • observance (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

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

CAD/CAM manufactured fixed unitary dental prostheses

Device: CAD/CAM manufactured fixed unitary dental prostheses

2

ACTIVE COMPARATOR

Conventionally manufactured unitary dental prostheses

Device: Conventionally manufactured unitary dental prostheses

Interventions

CAD/CAM manufactured fixed unitary dental prosthesesDEVICE
1
Conventionally manufactured unitary dental prosthesesDEVICE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Teeth:
  • Need for further prosthetic development (e. g. telescopic milled crown ) .
  • Extensive coronary reconstruction requiring de novo root anchorage (post-and-core)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Odontologie Hôpital Pitié salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Dental CariesTooth FracturesTooth Resorption

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth InjuriesWounds and Injuries

Study Officials

  • Jean Azerad, DDS, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

July 10, 2015

Study Start

February 1, 2014

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)