CariesCVBNCT03568253
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
A study testing Caries treatment in people with Caries, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Caries
- What is being tested?
- Caries treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2018to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Patient with risks of infectious endocarditis
- Non-cooperative patient
- Participate in another ongoing biomedical research
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Caries
- Being tested
- Caries treatment
- Keywords
- Bulk composite, High viscisity glassionomer, Cambra application (Caries management by risk assessment), E-dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries treatmentOther
Treatment by Bulk fil composite after randomization of the tooth
Caries treatmentOther
Treatment by High viscosity glass ionomer after randomization of the tooth
| Study group | Role | What they receive |
|---|---|---|
| Bulk fil composite | Active comparator | Not described Receives: Other: Caries treatment |
| High viscosity glass ionomer | Active comparator | Not described Receives: Other: Caries treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Score FDI at 2 years
Secondary outcomes (2)
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.
Measured: 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
Measured: At each follow-up visit (T0, T6 months, T1year and T2years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start21 Sep 2018
- Primary completion20 May 2023
- Study completion20 May 2023
Why it stopped: Covid situation / recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568253
- Sponsor's protocol ID
- 7550
- Acronym
- CVB
- Status last verified
- Aug 2024
- First submitted
- 14 May 2018
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03568253
- Acronym / sponsor ID
- CVB / 7550
- Conditions
- Caries
- Keywords
- Bulk composite, High viscisity glassionomer, Cambra application (Caries management by risk assessment), E-dentistry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid situation / recruitment difficulties
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulk fil composite | Active comparator | Other: Caries treatment |
| High viscosity glass ionomer | Active comparator | Other: Caries treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caries treatmentTreatment by Bulk fil composite after randomization of the tooth | Other | Bulk fil composite |
| Caries treatmentTreatment by High viscosity glass ionomer after randomization of the tooth | Other | High viscosity glass ionomer |
Primary outcome
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.
2 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)
Results and safety
The study was stopped early (reason given: Covid situation / recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caries treatment in people with Caries, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid situation / recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the International Dental Federation Score (time frame: Change from Baseline Score FDI at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.