Evaluation of Dental Coronal Restorations

Completed

• Conditions: History of at Least One Coronal Dental Restoration

• Registration Number: NCT03854526
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-24
• Study First Posted: 2019-02-26
• Study Start: 2019-03-28
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 863

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Status of coronary obturation with a simplified notation a, b or c	At day 0	notation is based on FDI (World Dental Federation) criteria

Trial Locations

Locations (61)

CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire; 🇫🇷 Bordeaux, France

Isabelle GIRSCHIG-ALLE; 🇫🇷 Boulogne, France

CHRU de Brest, Service Odontologie consultation spécialisée; 🇫🇷 Brest, France

CHRU de Brest, Service Odontologie; 🇫🇷 Brest, France

Stéphanie MIFSUD; 🇫🇷 Brindas, France

Laurianne DUDOUIT; 🇫🇷 Caluire-et-Cuire, France

Jean-Bruno LAFRASSE; 🇫🇷 Chambéry, France

Eric ROBBIANI; 🇫🇷 Chatillon, France

CHU Estaing, Service d'Odontologie; 🇫🇷 Clermont-Ferrand, France

APHP Hôpital Louis Mourier; 🇫🇷 Colombes, France

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