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Clinical Trials/NCT03854526
NCT03854526
Completed
Not Applicable

Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services

Hospices Civils de Lyon61 sites in 1 country863 target enrollmentMarch 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
History of at Least One Coronal Dental Restoration
Sponsor
Hospices Civils de Lyon
Enrollment
863
Locations
61
Primary Endpoint
Status of coronary obturation with a simplified notation a, b or c
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.

A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).

The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).

Registry
clinicaltrials.gov
Start Date
March 28, 2019
End Date
December 23, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient having read and signed the information letter attesting to his/her non-opposition
  • Affiliated to a social security scheme
  • Patient over 18 years old
  • New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months
  • Patient with at least one tooth with partial coronal restoration

Exclusion Criteria

  • Patient under tutorship or curatorship

Outcomes

Primary Outcomes

Status of coronary obturation with a simplified notation a, b or c

Time Frame: At day 0

notation is based on FDI (World Dental Federation) criteria

Study Sites (61)

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