NCT03854526: RESTO DATA

Evaluation of Dental Coronal Restorations

Completed Last updated 17 March 2022

What this trial tests

trial testing Evaluation of the quality of direct and indirect partial dental coronal restorations in adults in History of at Least One Coronal Dental Restoration in 863 participants. Completed in 23 December 2021.

Timeline

28 March 2019

Primary endpoint
23 December 2021

23 December 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	863
Start date	28 March 2019
Primary completion	23 December 2021
Estimated completion	23 December 2021
Sites	61 locations across France

Drugs / interventions tested

• Evaluation of the quality of direct and indirect partial dental coronal restorations in adults

Conditions studied

• History of at Least One Coronal Dental Restoration — all drugs for History of at Least One Coronal Dental Restoration →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with History of at Least One Coronal Dental Restoration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Outcomes of Direct Pulp Capping After Carious Excavation of Deep Caries on Permanent Mature Teeth: An Ancillary Study Derived From A Randomised Clinical Trial.
   Zanini M, Balice G, K Rour Dan O, L Z C, et al · · 2025 · cited 1× · PMID 41685840 · DOI 10.14744/eej.2025.38870
2. Influence of Root Canal Filling and Coronal Restoration Quality on Periapical Health: A Retrospective Observational Study.
   Gasqui MA, Perard M, Villat C, Decup F, et al · · 2026 · PMID 42181757 · DOI 10.1155/ijod/4108809