Clinical trial NCT03854526: Evaluation of Dental Coronal Restorations
Official title: Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: History of at Least One Coronal Dental Restoration
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with at least one dental restoration and consultant for the first time since at least six months in a private practice, or at hospital, in a classical odontological service or a consultation specializing in Gougerot Sjogren disease.

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).


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

Primary outcomes:
measure: Status of coronary obturation with a simplified notation a, b or c
timeFrame: At day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire
city: Boulogne
country: France
facility: Isabelle GIRSCHIG-ALLE
city: Brest
country: France
facility: CHRU de Brest, Service Odontologie consultation spécialisée
city: Brest
country: France
facility: CHRU de Brest, Service Odontologie
city: Brindas
country: France
facility: Stéphanie MIFSUD
city: Caluire-et-Cuire
country: France
facility: Laurianne DUDOUIT
city: Chambéry
country: France
facility: Jean-Bruno LAFRASSE
city: Chatillon
country: France
facility: Eric ROBBIANI
city: Clermont-Ferrand
country: France
facility: CHU Estaing, Service d'Odontologie
city: Colombes
country: France
facility: APHP Hôpital Louis Mourier
city: Créteil
country: France
facility: APHP, Hopital Henri Mondor, Service de Médecine Bucco-Dentaire
city: Créteil
country: France
facility: Selma OULADDIAF
city: Décines-Charpieu
country: France
facility: Justine LOSSI
city: Décines-Charpieu
country: France
facility: Nicolas KAPRIELIAN
city: Garches
country: France
facility: Alix SAUVAGNAC
city: Issoire
country: France
facility: François-Marie DUTOUR
city: Ivry-sur-Seine
country: France
facility: APHP Hôpital Charles Foix, Service Odontologie consultation spécialisée
city: Ivry-sur-Seine
country: France
facility: APHP Hôpital Charles Foix, Service Odontologie
city: La Fouillouse
country: France
facility: Camille TOURNADRE
city: Le Mesnil Saint Denis
country: France
facility: Aurélie TRUFFINET
city: Lille
country: France
facility: CHU Lille, Service d'Odontologie
city: Lyon
country: France
facility: Valentin GARYGA
city: Lyon
country: France
facility: Marie-Anne MY
city: Lyon
country: France
facility: Stéphanie GAUTHEROT
city: Lyon
country: France
facility: Alexandra DAVID
city: Lyon
country: France
facility: Arnaud JANIN
city: Lyon
country: France
facility: Hospices Civils de Lyon, Service d'Odontologie
city: Lyon
country: France
facility: Philippe GERENTES
city: Montalieu-Vercieu
country: France
facility: Jérémie DECHAUX
city: Neuilly sur Seine
country: France
facility: Claire FRANCHI
city: Neuilly sur seine
country: France
facility: Solène MARNIQUET
city: Nice
country: France
facility: CHU, Service d'Odontologie
city: Paris
country: France
facility: Céline VINTER
city: Paris
country: France
facility: Valérie AMZALLAG GUIDONI
city: Paris
country: France
facility: Jonathan CHESNEAU
city: Paris
country: France
facility: Anne Claire LOISEAU
city: Paris
country: France
facility: Thibault DROUHET
city: Paris
country: France
facility: AP-HP, Hopital Rothschlid
city: Paris
country: France
facility: Aurélia GUERRIERI
city: Paris
country: France
facility: Florent TREVELO
city: Paris
country: France
facility: Christian MOUSSALLY
city: Paris
country: France
facility: Anthony ATLAN
city: Paris
country: France
facility: Franck DECUP
city: Paris
country: France
facility: Magali RENEAU
city: Paris
country: France
facility: Maxime DROSSART
city: Paris
country: France
facility: Catherine MESGOUEZ-MENEZ
city: Reims
country: France
facility: CHU de Reims, Pôle de Médecine Bucco-Dentaire
city: Rennes
country: France
facility: CHU, Centre de soins Dentaires
city: Roanne
country: France
facility: Florian POCHELU
city: Rueil Malmaison
country: France
facility: Nathalie DELARGE DIONIS
city: Saint-Marcellin en Forez
country: France
facility: Nicolas PERIER
city: Solaize
country: France
facility: Jacques TIXIER
city: St Just St Rambert
country: France
facility: Gaëlle CHOMETTE
city: Toulouse
country: France
facility: CHU de Toulouse, Service d'Odontologie
city: Versailles
country: France
facility: Laure DECHELETTE
city: Vienne
country: France
facility: Anaïs CHABANNE
city: Villefranche-sur-Saône
country: France
facility: Harmik MINASSIAN
city: Villefranche-sur-Saône
country: France
facility: Xavier BONDIL
city: Villiers sur Marne
country: France
facility: Nathalie JANISSET-MASSE
city: Échirolles
country: France
facility: Jérôme PIEAUD
city: Échirolles
country: France
facility: Laura COHEN BOULAKIA
Study officials:
affiliation: Hospices Civils de Lyon
name: Brigitte GROSGOGEAT, Professor
role: STUDY_DIRECTOR
affiliation: Assistance Publique des Hopitaux de Paris
name: Franck DECUP, Associate Professor
role: STUDY_DIRECTOR
References: