Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
863 participants
OBSERVATIONAL
2019-03-28
2021-12-23
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patients without Gougerot Sjogren disease
New patient, or patient, with no history of a dental examination in the last six months and with at least one tooth with coronal dental restoration
Evaluation of the quality of direct and indirect partial dental coronal restorations in adults
The medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF.
All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning.
Patients with Gougerot Sjogren disease
New patient, or patient, with no history of a dental examination in the last six months, with at least one tooth with coronal dental restoration and presenting a Gougerot Sjogren disease
Evaluation of the quality of direct and indirect partial dental coronal restorations in adults
The medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF.
All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning.
Interventions
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Evaluation of the quality of direct and indirect partial dental coronal restorations in adults
The medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF.
All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Brigitte GROSGOGEAT, Professor
Role: STUDY_DIRECTOR
Hospices Civils de Lyon
Franck DECUP, Associate Professor
Role: STUDY_DIRECTOR
Assistance Publique des Hopitaux de Paris
Locations
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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
Châtillon, , 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 consultation spécialisée
Ivry-sur-Seine, , France
APHP Hôpital Charles Foix, Service Odontologie
Ivry-sur-Seine, , France
Camille TOURNADRE
La Fouillouse, , France
Aurélie TRUFFINET
Le Mesnil-Saint-Denis, , France
CHU Lille, Service d'Odontologie
Lille, , France
Valentin GARYGA
Lyon, , France
Marie-Anne MY
Lyon, , France
Stéphanie GAUTHEROT
Lyon, , France
Alexandra DAVID
Lyon, , France
Arnaud JANIN
Lyon, , France
Hospices Civils de Lyon, Service d'Odontologie
Lyon, , France
Philippe GERENTES
Lyon, , France
Jérémie DECHAUX
Montalieu, , France
Claire FRANCHI
Neuilly-sur-Seine, , France
Solène MARNIQUET
Neuilly-sur-Seine, , France
CHU, Service d'Odontologie
Nice, , France
Céline VINTER
Paris, , France
Valérie AMZALLAG GUIDONI
Paris, , France
Jonathan CHESNEAU
Paris, , France
Anne Claire LOISEAU
Paris, , France
Thibault DROUHET
Paris, , France
AP-HP, Hopital Rothschlid
Paris, , France
Aurélia GUERRIERI
Paris, , France
Florent TREVELO
Paris, , France
Christian MOUSSALLY
Paris, , France
Anthony ATLAN
Paris, , France
Franck DECUP
Paris, , France
Magali RENEAU
Paris, , France
Maxime DROSSART
Paris, , France
Catherine MESGOUEZ-MENEZ
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
Gaëlle CHOMETTE
Saint-Just-Saint-Rambert, , France
Nicolas PERIER
Saint-Marcellin-en-Forez, , France
Jacques TIXIER
Solaize, , 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, , France
Countries
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Other Identifiers
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69HCL18_0759
Identifier Type: -
Identifier Source: org_study_id
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