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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Treatment by Bulk fil composite after randomization of the tooth
Treatment by High viscosity glass ionomer after randomization of the tooth
CHU Montpellier
Montpellier, France
Evaluation of the International Dental Federation Score
Score are numbered from 1 to 5 in ascending order of severity for aesthetic criteria (5 items), functional criteria (9 items) and biological criteria (6 items). The score will be used by the practionner making the restoration and by the remote expert to check the results and validate tele-dentistry evaluation.
Time frame: Change from Baseline Score FDI at 2 years
Validation of the caries risk assememt.
Caries assessment is based on CAMBRA application https://course.mycambra.com/ (Caries Management By Risk Assessment) score giving 3 levels of caries assessment : Low - Moderate - High.
Time frame: Change from Baseline caries risk assement at 2 years
The carious presence according to the ICDAS / ICCMS criteria using the Soprolife® camera
ICCMS: caries prevalence measurement based on the ICDAS classification
Time frame: At each follow-up visit (T0, T6 months, T1year and T2years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.