Molar Incisor HypomineralizationMIhCFAONCT04922177
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
A study testing Indirect ceramic restoration and Direct restoration in people with Molar Incisor Hypomineralization, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Molar Incisor Hypomineralization (MIH) is a disease causing a structural defect in the enamel of permanent teeth. The treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. Classically, the restoration is done with a resin in direct method. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Indirect ceramic restoration and Direct restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2021to Dec 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child from 7 to 12 years old presenting a mild to moderate HIN on at least one permanent first molar requiring reconstitution.
- Child presenting a state of anxiety compatible with the provision of oral care (score on the Venham scale modified by Veerkamp below 2).
- Child affiliated to or benefiting from a social security scheme.
- Free, informed and signed consent by the parent(s)/holder(s) of parental authority and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Oral consent of the child.
- Non-inclusion criteria:
Show all 11Show fewer
- Child presenting an allergy or a history of allergy to one of the constituents of biomaterials
- Child with fluorosis
- Child with amelogenesis imperfecta
- Child with pacemaker (contraindication to CAD/CAM)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital of Toulouse
Toulouse, 31062
Mathieu Marty, marty.mat@chu-toulouse.fr
Mathieu Marty
About this study
Official title: Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study
Molar Incisor Hypomineralization (MIH) is a disease causing a structural defect in the enamel of permanent teeth. The treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. Classically, the restoration is done with a resin in direct method. With the development of Computer-aided design (CAD) and Computer-aided manufacturing (CAM), it is possible to make a custom-made part to replace the affected part of the tooth. The main objective is to describe the effect of the 6-month management of CAD/CAM type restorations compared to direct restorations, performed in children aged 7 to 12 years with mild to moderate MIH on permanent molar teeth.
Read the detailed description
Molar Incisor Hypomineralization (MIH) is a structural defect of the enamel affecting at least one of the first four permanent molars. The prevalence is high, ranging from 20% to 40% of children. The consequences of MIH are multiple, including pain during food intake or an increased risk for the development of carious disease. The current standard protocol for mild to moderate MIH is the use of direct restorations (Glass Cement Ionomer type). However, this therapy is not suitable due to frequent failures. In terms of longevity, indirect restorations are superior to direct restorations. CAD/CAM in dentistry offers the possibility of making these inlay/onlay type perennial coronary restorations. It is faster to implement and does not require a conventional impression.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Indirect ceramic restoration, Direct restoration
- Keywords
- Molar Incisor Hypomineralization, Direct restauration, Computer-aided design (CAD), Computer-aided manufacturing (CAM)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect ceramic restorationProcedure or surgery
Indirect ceramic restoration using an optical impression.
Direct restorationProcedure or surgery
Restoration using a Glass Ionomer Cement
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Group | Experimental | For the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression. Receives: Procedure: Indirect ceramic restoration |
| Direct method Group | Active comparator | For the direct method group, a restoration using a Glass Ionomer Cement will be performed. Receives: Procedure: Direct restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect
The effect of the management of the MIH will be assessed by the occurrence of failure. Failure will be diagnosed from the degree of demineralisation measured, by laser fluorescence at the peripheral tooth/restoration joint. The values collected range from 0 to 99 and are categorised into 3 situations :
- From 0 to 12: situation without demineralization, tight seal.
- From 13 to 24: start of demineralization
- ≥ 25: therapeutic failure, non-watertight seal, restoration to be redone without delay.
Measured: 6 months
Secondary outcomes (2)
Failure
Failure diagnosed according to the degree of demineralisation measured, every 3 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.
Measured: 3 months
Failure
Failure diagnosed according to the degree of demineralisation measured, every 12 months following the restoration, by laser fluorescence at the peripheral tooth/restoration joint.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu MARTY, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922177
- Sponsor's protocol ID
- RC31/19/0053
- Acronym
- MIhCFAO
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study
- ClinicalTrials.gov ID
- NCT04922177
- Acronym / sponsor ID
- MIhCFAO / RC31/19/0053
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization, Direct restauration, Computer-aided design (CAD), Computer-aided manufacturing (CAM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jun 2021 (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.
Molar Incisor Hypomineralization (MIH) is a disease causing a structural defect in the enamel of permanent teeth. The treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. Classically, the restoration is done with a resin in direct method. With the development of Computer-aided design (CAD) and Computer-aided manufacturing (CAM), it is possible to make a custom-made part to replace the affected part of the tooth. The main objective is to describe the effect of the 6-month management of CAD/CAM type restorations compared to direct restorations, performed in children aged 7 to 12 years with mild to moderate MIH on permanent molar teeth.
Detailed description
Molar Incisor Hypomineralization (MIH) is a structural defect of the enamel affecting at least one of the first four permanent molars. The prevalence is high, ranging from 20% to 40% of children. The consequences of MIH are multiple, including pain during food intake or an increased risk for the development of carious disease. The current standard protocol for mild to moderate MIH is the use of direct restorations (Glass Cement Ionomer type). However, this therapy is not suitable due to frequent failures. In terms of longevity, indirect restorations are superior to direct restorations. CAD/CAM in dentistry offers the possibility of making these inlay/onlay type perennial coronary restorations. It is faster to implement and does not require a conventional impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Group | Experimental | Procedure: Indirect ceramic restorationFor the CAD/CAM group, an indirect ceramic restoration will be made using an optical impression. |
| Direct method Group | Active comparator | Procedure: Direct restorationFor the direct method group, a restoration using a Glass Ionomer Cement will be performed. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Non-inclusion criteria:
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Indirect ceramic restorationIndirect ceramic restoration using an optical impression. | Procedure or surgery | CAD/CAM Group |
| Direct restorationRestoration using a Glass Ionomer Cement | Procedure or surgery | Direct method Group |
Primary outcome
Treatment effect
Time frame: 6 months
The effect of the management of the MIH will be assessed by the occurrence of failure. Failure will be diagnosed from the degree of demineralisation measured, by laser fluorescence at the peripheral tooth/restoration joint. The values collected range from 0 to 99 and are categorised into 3 situations : * From 0 to 12: situation without demineralization, tight seal. * From 13 to 24: start of demineralization * ≥ 25: therapeutic failure, non-watertight seal, restoration to be redone without delay.
2 secondary outcomes
Failure
Time frame: 3 months
Failure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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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.
Mathieu MARTY principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect ceramic restoration and Direct restoration in people with Molar Incisor Hypomineralization, run by University Hospital, Toulouse 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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu MARTY (06.79.97.47.11, marty.mat@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect (time frame: 6 months). 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 10 Jun 2021.