---
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"
nct_id: NCT03568253
overall_status: TERMINATED
phase: NA
sponsor: University Hospital, Montpellier
study_type: INTERVENTIONAL
primary_condition: Caries
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03568253.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03568253"
ct_last_update_post_date: 2024-08-12
last_seen_at: "2026-05-12T07:11:20.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**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)

**NCT ID:** [NCT03568253](https://clinicaltrials.gov/study/NCT03568253)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Covid situation / recruitment difficulties
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 65
- **Lead Sponsor:** University Hospital, Montpellier
- **Conditions:** Caries
- **Start Date:** 2018-09-21
- **Completion Date:** 2023-05-20
- **CT.gov Last Update:** 2024-08-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Bulk fil composite** (ACTIVE_COMPARATOR)
- **High viscosity glass ionomer** (ACTIVE_COMPARATOR)

## Interventions

- **Caries treatment** (OTHER) — Treatment by Bulk fil composite after randomization of the tooth
- **Caries treatment** (OTHER) — Treatment by High viscosity glass ionomer after randomization of the tooth

## Primary Outcomes

- **Evaluation of the International Dental Federation Score** _(time frame: 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 Outcomes

- **Validation of the caries risk assememt.** _(time frame: Change from Baseline caries risk assement at 2 years)_
- **The carious presence according to the ICDAS / ICCMS criteria using the Soprolife® camera** _(time frame: At each follow-up visit (T0, T6 months, T1year and T2years))_

## Locations (1)

- CHU Montpellier, Montpellier, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu montpellier|montpellier||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03568253*  
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