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

Caries Clinical Trial

— CVB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568253
• Other study ID #: 7550
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2018
• Source: University Hospital, Montpellier
• Contact: Hervé TASSERY, Professor
• Phone: +3360383919
• Email: herve.tassery[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries

Intervention

Other:
• Caries treatment
Treatment by Bulk fil composite after randomization of the tooth
• Caries treatment
Treatment by High viscosity glass ionomer after randomization of the tooth

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)