CVB: 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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT03568253

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries	Other: Caries treatment Other: Caries treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 30, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Bulk fil composite

Other: Caries treatment

Treatment by Bulk fil composite after randomization of the tooth

Active Comparator: High viscosity glass ionomer

Other: Caries treatment

Treatment by High viscosity glass ionomer after randomization of the tooth

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Montpellier	Montpellier		France	34090

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03568253

Other Study ID Numbers:

7550

First Posted:

Jun 26, 2018

Last Update Posted:

Jun 26, 2018

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Bulk composite

High viscisity glassionomer

Cambra application (Caries management by risk assessment)

E-dentistry

Study Results

No Results Posted as of Jun 26, 2018