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

NCT ID: NCT03568253

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2023-05-20

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.

Conditions

Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bulk fil composite

Group Type: ACTIVE_COMPARATOR

Caries treatment

Intervention Type: OTHER

Treatment by Bulk fil composite after randomization of the tooth

High viscosity glass ionomer

Group Type: ACTIVE_COMPARATOR

Caries treatment

Intervention Type: OTHER

Treatment by High viscosity glass ionomer after randomization of the tooth

Interventions

Caries treatment

Treatment by Bulk fil composite after randomization of the tooth

Intervention Type: OTHER

Caries treatment

Treatment by High viscosity glass ionomer after randomization of the tooth

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Montpellier

Montpellier, , France

Countries

France

Other Identifiers

7550

Identifier Type: -

Identifier Source: org_study_id