Caries
Conditions
Keywords
Bulk composite, High viscisity glassionomer, Cambra application (Caries management by risk assessment), E-dentistry
Brief 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.
Interventions
OTHERCaries treatment
Treatment by Bulk fil composite after randomization of the tooth
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient with 2 carious lesions (or multiple of 2) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin * Asymptomatic tooth or with a reversible pulp syndrome tooth * Measured by pulp test (if not possible should not prevent the inclusion) * Patient consultant in investigative testing center * Patient of 18 to 70 years old * Patient able to support care * Patient able to understand care (no language barrier) * Collect the informed consent signed after a period of reflection * Be affiliated to a French social security scheme or recipient of such a regime * Tooth with criteria for pulp vitality tests of pulp sensibility
Exclusion criteria
* Patient under guardianship * Pregnant or breastfeeding * Patient at risk for infectious endocarditis * Patient with severe periodontal disease (Pocket depth ≥ 5mm and/or mobility IV) * Patient with an allergy to one of the materials used in the study * Patient with an allergy to local anesthesia * Patient with risks of infectious endocarditis * Non-cooperative patient * Participate in another ongoing biomedical research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the International Dental Federation Score | Change from Baseline Score FDI at 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of the caries risk assememt. | Change from Baseline caries risk assement at 2 years | 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. |
| The carious presence according to the ICDAS / ICCMS criteria using the Soprolife® camera | At each follow-up visit (T0, T6 months, T1year and T2years) | ICCMS: caries prevalence measurement based on the ICDAS classification |
Countries
France
Outcome results
None listed