History of at Least One Coronal Dental Restoration Clinical Trial
— RESTO DATAOfficial 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
| Verified date | March 2022 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 863 |
| Est. completion date | December 23, 2021 |
| Est. primary completion date | December 23, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire | Bordeaux | |
| France | Isabelle GIRSCHIG-ALLE | Boulogne | |
| France | CHRU de Brest, Service Odontologie | Brest | |
| France | CHRU de Brest, Service Odontologie consultation spécialisée | 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 | APHP, Hopital Henri Mondor, Service de Médecine Bucco-Dentaire | Créteil | |
| France | Selma OULADDIAF | Créteil | |
| France | Justine LOSSI | Décines-Charpieu | |
| France | Nicolas KAPRIELIAN | Décines-Charpieu | |
| France | Jérôme PIEAUD | Échirolles | |
| France | Laura COHEN BOULAKIA | Échirolles | |
| France | Alix SAUVAGNAC | Garches | |
| France | François-Marie DUTOUR | Issoire | |
| France | APHP Hôpital Charles Foix, Service Odontologie | Ivry-sur-Seine | |
| France | APHP Hôpital Charles Foix, Service Odontologie consultation spécialisée | Ivry-sur-Seine | |
| France | Camille TOURNADRE | La Fouillouse | |
| France | Aurélie TRUFFINET | Le Mesnil Saint Denis | |
| France | CHU Lille, Service d'Odontologie | Lille | |
| France | Alexandra DAVID | Lyon | |
| France | Arnaud JANIN | Lyon | |
| France | Hospices Civils de Lyon, Service d'Odontologie | Lyon | |
| France | Marie-Anne MY | Lyon | |
| France | Philippe GERENTES | Lyon | |
| France | Stéphanie GAUTHEROT | Lyon | |
| France | Valentin GARYGA | Lyon | |
| France | Jérémie DECHAUX | Montalieu-Vercieu | |
| France | Claire FRANCHI | Neuilly sur Seine | |
| France | Solène MARNIQUET | Neuilly sur seine | |
| France | CHU, Service d'Odontologie | Nice | |
| France | Anne Claire LOISEAU | Paris | |
| France | Anthony ATLAN | Paris | |
| France | AP-HP, Hopital Rothschlid | Paris | |
| France | Aurélia GUERRIERI | Paris | |
| France | Catherine MESGOUEZ-MENEZ | Paris | |
| France | Céline VINTER | Paris | |
| France | Christian MOUSSALLY | Paris | |
| France | Florent TREVELO | Paris | |
| France | Franck DECUP | Paris | |
| France | Jonathan CHESNEAU | Paris | |
| France | Magali RENEAU | Paris | |
| France | Maxime DROSSART | Paris | |
| France | Thibault DROUHET | Paris | |
| France | Valérie AMZALLAG GUIDONI | Paris | |
| France | CHU de Reims, Pôle de Médecine Bucco-Dentaire | Reims | |
| France | CHU, Centre de soins Dentaires | Rennes | |
| France | Florian POCHELU | Roanne | |
| France | Nathalie DELARGE DIONIS | Rueil Malmaison | |
| France | Nicolas PERIER | Saint-Marcellin en Forez | |
| France | Jacques TIXIER | Solaize | |
| France | Gaëlle CHOMETTE | St Just St Rambert | |
| France | CHU de Toulouse, Service d'Odontologie | Toulouse | |
| France | Laure DECHELETTE | Versailles | |
| France | Anaïs CHABANNE | Vienne | |
| France | Harmik MINASSIAN | Villefranche-sur-Saône | |
| France | Xavier BONDIL | Villefranche-sur-Saône | |
| France | Nathalie JANISSET-MASSE | Villiers sur Marne |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Status of coronary obturation with a simplified notation a, b or c | notation is based on FDI (World Dental Federation) criteria | At day 0 |