Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar In… (NCT07727200) | Clinical Trial Compass
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Correlation Between Colour of Defect and Enamel Breakdown in First Permanent Molars With Molar Incisor Hypomineralisation (MIH)
Switzerland45 participantsStarted 2026-01-09
Plain-language summary
Cheese molars (MIH) can be recognized not only by their colour abnormalities but also by the enamel breakdown. Clinical management of those teeth may become challenging by the chronic hypersensitivity, that makes various steps during treatment, such as pain control or light curing of any type of composite restorations, difficult or even impossible, despite profound local anaesthesia. The aim of this study is to determine the relationship between colour of the defect and loss of ename in the affected teeth. A correlation between colour of the defect and risk of enamel breakdown could enable early prognosis leading to preventive measures in order to delay or even avoid completely any breakdown of the enamel. Children diagnosed with MIH on their first permanent molars of different severity are matched to children with sound molars. They are identified by the annual school dental check-up and are invited to take part in the study. The children will be invited to the university dental clinic via letter for the first appointment. Upon parental consent, the teeth will be photographed and scanned on the first appointment. Three follo-up appointments will be organised in order to take pictures and scan again the teeth. The baselne scan of the tetth will be compared to the scans of the subsequent appointments in order to measure the level of enamel breakdown and correlate it to the colour of the defect.
Who can participate
Age range
5 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
MIH Study Group
Inclusion Criteria:
* Children between 5 to 8 years with MIH molars with or without hypersensitivity according to the MIH-TN Index (Bekes et al 2016)
* Children with first molars in occlusion
* Children fit and healthy
Exclusion Criteria:
* MIH first permanent molars that have already received any kind of dental treatment
* Children diagnosed with HSPM (hypomineralised second primary molars)
* Children older than 8 years - Children younger than 5 years
* Children with any cranio-facial and/or other developmental dental defects
* Children diagnosed with parafunctions (attrition/ erosion)
* Children and/or parents who did not consent to the study
* Children with MIH teeth that show clinically visible enamel loss during the eruption
* Children without the first molars in occlusion
Non- MIH Control Group
Inclusion Criteria:
* Children between 5 to 8 years with no clinically affected molars- Page 4 of 5
* Children fit and healthy
Exclusion Criteria:
* Children who have already received any kind of dental treatment on their permanent or primary teeth
* Children diagnosed with MIH or any other disease of the teeth
* Children older than 8 years
* Children younger than 5 years
* Children with any cranio-facial and/or other developmental dental defects
* Children diagnosed with parafunctions (attrition/ erosion)
* Children and/or parents who did not consent to the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Colour of the defect
Timeframe: Baseline appointment until the 9-months follow-up appointment
2
Enamel breakdown
Timeframe: From enrollment to the last follow-up appointment at 9 months