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Clinical Trial Summary

The main objective is the longitudinal follow-up and comparison of the maintenance of the dental filling materials up to 24 months using the HVGIC IonoStar Plus versus Bulk X-Tra -Fil composite (Futurabond U adhesive system). 150 patients will be recruited in the Mafate dental health center. Patients with minimum 2 carious lesions (or multiple of 2, maximum 6) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin. Assignment period will be 4 years: Inclusion period 18 months with 2 years following (6-month, 1 year and 2 years checking) and 3 months for statistical analysis and publications process Estimation of the parameters associated with a failure of the restoration at 24 months will follow the FDI scores. The Secondary objectives are to evaluate the caries risk of isolated population thanks to Cambra application and estimate the concordance of the judgment of maintaining the restoration between the expert in-situ and experts based on the images remotely.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03568253
Study type Interventional
Source University Hospital, Montpellier
Contact Hervé TASSERY, Professor
Phone +3360383919
Email herve.tassery@gmail.com
Status Recruiting
Phase N/A
Start date June 30, 2018
Completion date June 1, 2022

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