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Evaluation of Dental Coronal Restorations

Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03854526
Acronym
RESTO DATA
Enrollment
863
Registered
2019-02-26
Start date
2019-03-28
Completion date
2021-12-23
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

History of at Least One Coronal Dental Restoration

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).

Interventions

OTHEREvaluation 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

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Status of coronary obturation with a simplified notation a, b or cAt day 0notation is based on FDI (World Dental Federation) criteria

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026