NCT03568253

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4.7 years

First QC Date

May 14, 2018

Last Update Submit

August 8, 2024

Conditions

Caries

Keywords

Bulk compositeHigh viscisity glassionomerCambra application (Caries management by risk assessment)E-dentistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Validation of the caries risk assememt.

    Change from Baseline caries risk assement at 2 years

  • The carious presence according to the ICDAS / ICCMS criteria using the Soprolife® camera

    At each follow-up visit (T0, T6 months, T1year and T2years)

Study Arms (2)

Bulk fil composite

ACTIVE COMPARATOR
Other: Caries treatment

High viscosity glass ionomer

ACTIVE COMPARATOR
Other: Caries treatment

Interventions

Caries treatmentOTHER

Treatment by Bulk fil composite after randomization of the tooth

Bulk fil composite

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34090, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 26, 2018

Study Start

September 21, 2018

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

FR(1)