Evaluation of Dental Coronal Restorations

NCT ID: NCT03854526

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

863 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-28

Study Completion Date

2021-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

History of at Least One Coronal Dental Restoration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brigitte GROSGOGEAT, Professor

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Franck DECUP, Associate Professor

Role: STUDY_DIRECTOR

Assistance Publique des Hopitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire

Bordeaux, , France

Site Status

Isabelle GIRSCHIG-ALLE

Boulogne, , France

Site Status

CHRU de Brest, Service Odontologie consultation spécialisée

Brest, , France

Site Status

CHRU de Brest, Service Odontologie

Brest, , France

Site Status

Stéphanie MIFSUD

Brindas, , France

Site Status

Laurianne DUDOUIT

Caluire-et-Cuire, , France

Site Status

Jean-Bruno LAFRASSE

Chambéry, , France

Site Status

Eric ROBBIANI

Châtillon, , France

Site Status

CHU Estaing, Service d'Odontologie

Clermont-Ferrand, , France

Site Status

APHP Hôpital Louis Mourier

Colombes, , France

Site Status

APHP, Hopital Henri Mondor, Service de Médecine Bucco-Dentaire

Créteil, , France

Site Status

Selma OULADDIAF

Créteil, , France

Site Status

Justine LOSSI

Décines-Charpieu, , France

Site Status

Nicolas KAPRIELIAN

Décines-Charpieu, , France

Site Status

Jérôme PIEAUD

Échirolles, , France

Site Status

Laura COHEN BOULAKIA

Échirolles, , France

Site Status

Alix SAUVAGNAC

Garches, , France

Site Status

François-Marie DUTOUR

Issoire, , France

Site Status

APHP Hôpital Charles Foix, Service Odontologie consultation spécialisée

Ivry-sur-Seine, , France

Site Status

APHP Hôpital Charles Foix, Service Odontologie

Ivry-sur-Seine, , France

Site Status

Camille TOURNADRE

La Fouillouse, , France

Site Status

Aurélie TRUFFINET

Le Mesnil-Saint-Denis, , France

Site Status

CHU Lille, Service d'Odontologie

Lille, , France

Site Status

Valentin GARYGA

Lyon, , France

Site Status

Marie-Anne MY

Lyon, , France

Site Status

Stéphanie GAUTHEROT

Lyon, , France

Site Status

Alexandra DAVID

Lyon, , France

Site Status

Arnaud JANIN

Lyon, , France

Site Status

Hospices Civils de Lyon, Service d'Odontologie

Lyon, , France

Site Status

Philippe GERENTES

Lyon, , France

Site Status

Jérémie DECHAUX

Montalieu, , France

Site Status

Claire FRANCHI

Neuilly-sur-Seine, , France

Site Status

Solène MARNIQUET

Neuilly-sur-Seine, , France

Site Status

CHU, Service d'Odontologie

Nice, , France

Site Status

Céline VINTER

Paris, , France

Site Status

Valérie AMZALLAG GUIDONI

Paris, , France

Site Status

Jonathan CHESNEAU

Paris, , France

Site Status

Anne Claire LOISEAU

Paris, , France

Site Status

Thibault DROUHET

Paris, , France

Site Status

AP-HP, Hopital Rothschlid

Paris, , France

Site Status

Aurélia GUERRIERI

Paris, , France

Site Status

Florent TREVELO

Paris, , France

Site Status

Christian MOUSSALLY

Paris, , France

Site Status

Anthony ATLAN

Paris, , France

Site Status

Franck DECUP

Paris, , France

Site Status

Magali RENEAU

Paris, , France

Site Status

Maxime DROSSART

Paris, , France

Site Status

Catherine MESGOUEZ-MENEZ

Paris, , France

Site Status

CHU de Reims, Pôle de Médecine Bucco-Dentaire

Reims, , France

Site Status

CHU, Centre de soins Dentaires

Rennes, , France

Site Status

Florian POCHELU

Roanne, , France

Site Status

Nathalie DELARGE DIONIS

Rueil-Malmaison, , France

Site Status

Gaëlle CHOMETTE

Saint-Just-Saint-Rambert, , France

Site Status

Nicolas PERIER

Saint-Marcellin-en-Forez, , France

Site Status

Jacques TIXIER

Solaize, , France

Site Status

CHU de Toulouse, Service d'Odontologie

Toulouse, , France

Site Status

Laure DECHELETTE

Versailles, , France

Site Status

Anaïs CHABANNE

Vienne, , France

Site Status

Harmik MINASSIAN

Villefranche-sur-Saône, , France

Site Status

Xavier BONDIL

Villefranche-sur-Saône, , France

Site Status

Nathalie JANISSET-MASSE

Villiers-sur-Marne, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL18_0759

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ONE-1 Oral graNd Est 1
NCT05089214 UNKNOWN NA