Longitudinal Follow-up of High Viscosity Glassionomer IonoStar Plus Versus a Composite Bulk X-tra-Fil Combined With Futurabond U (Splith Mouth Study): Reunion Island, Circus of Mafate

Study Overview
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Brief Summary
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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.

Official Title
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Longitudinal Follow-up of High Viscosity Glassionomer IonoStar Plus Versus a Composite Bulk X-tra-Fil Combined With Futurabond U (Splith Mouth Study): Reunion Island, Circus of Mafate

Conditions
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Caries

Intervention / Treatment
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* Other: Caries treatment
* Other: Caries treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bulk fil composite<br> | Other: Caries treatment<br>* Treatment by Bulk fil composite after randomization of the tooth<br>|
| Active Comparator: High viscosity glass ionomer<br> | Other: Caries treatment<br>* Treatment by High viscosity glass ionomer after randomization of the tooth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline Score FDI at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | At each follow-up visit (T0, T6 months, T1year and T2years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cambra application (Caries management by risk assessment), E-dentistry, Bulk composite, High viscisity glassionomer