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Evaluation of Dental Coronal Restorations

NCT03854526 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 863

Last updated 2022-03-17

No results posted yet for this study

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).

Conditions

  • History of at Least One Coronal Dental Restoration

Interventions

OTHER

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Brigitte GROSGOGEAT, Professor · Hospices Civils de Lyon

  • Franck DECUP, Associate Professor · Assistance Publique des Hopitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854526 on ClinicalTrials.gov