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 (CVB)

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 Overview

• Status: Unknown
• Conditions: Caries
• Intervention / Treatment: Other: Caries treatment; Other: Caries treatment

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Recruiting
    • CHU Montpellier
    • Contact: Hervé TASSERY, Professor; Phone Number: +33603839119; Email: herve.tassery@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bulk fil composite	Other: Caries treatment; Treatment by Bulk fil composite after randomization of the tooth; Other: Caries treatment; Treatment by High viscosity glass ionomer after randomization of the tooth
Active Comparator: High viscosity glass ionomer	Other: Caries treatment; Treatment by Bulk fil composite after randomization of the tooth; Other: Caries treatment; Treatment by High viscosity glass ionomer after randomization of the tooth

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Bulk composite; High viscisity glassionomer; Cambra application (Caries management by risk assessment); E-dentistry
• Other Study ID Numbers: 7550

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No