Molar Incisor Hypomineralisation and Dental Anomalies
United Kingdom1,279 participantsStarted 2022-11-29
Plain-language summary
Background/study aim:
Molar incisor hypomineralisation (MIH) is a common disorder of tooth development. Affected teeth have weak enamel and adult molars often require extensive treatment or even extraction. A preliminary study, carried out in Sheffield Dental Hospital, discovered that 12% of MIH children also had congenitally missing adult teeth, presenting further challenges to treatment-planning. This novel finding stimulated discussion between international MIH experts; whilst some clinicians had observed this association, others had not. Therefore the primary aim of this international study is to determine the association between MIH and missing teeth in different populations. This has important clinical and biological relevance in understanding the presentation and management of MIH.
Participants/research sites:
This study will include 584 children with MIH and a comparison group of 584 children without MIH. Young dental patients, aged 7-16 years, who attend for a check-up or treatment at one of the 15 participating countries will be invited to take part. The UK sites are Sheffield, Newcastle and University College London Dental Hospitals and all children will be seen by specialists/consultants in paediatric dentistry to confirm their diagnosis of MIH. The main inclusion criteria is that children have a dental xray as part of their routine care.
Data collection:
Following a routine dental check-up we will grade the severity of the participants' MIH (if present) and record any other dental anomalies (e.g. abnormal tooth number, position or shape). We will also check the dental xray for other anomalies that cannot be seen from the clinical exam. We will analyse the prevalence of MIH and association with other dental anomalies to see if there are difference according to sex or ethnicity and compare our findings with the non-MIH group. We anticipate the study will take 18 months.
Who can participate
Age range
7 Years – 16 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.
Eligibility criteria Participants are children aged 7-16 years-old, with and without MIH, who meet the inclusion criteria, and attend for assessment or treatment in the participating clinics. To avoid bias, the comparison group will not be solely drawn from a pool of orthodontic patients or those primarily referred with a known diagnosis of dental anomalies
Generic inclusion criteria - all participants (both MIH and comparison groups)
* No significant medical history (ASA ≤ 2), syndromic conditions, cleft lip and/or palate.
* Have an existing (full) pan-oral radiograph at recruitment or subsequently undergoes one for routine diagnostic purposes.
* Child able to accept detailed clinical examination, radiographs (and photographs).
* Parents and child able to consent/assent to participate in the study and have sufficient level of literacy/understanding to complete written consent forms (with support if necessary).
MIH-group specific inclusion criteria.
* Children diagnosed with MIH by a specialist in paediatric dentistry according to validated diagnostic criteria (Ghanim et al., 2017, Ghanim et al., 2019) Comparison-group specific inclusion criteria
* Children referred to the host centre for the management of any dental condition other than MIH.
MIH-group specific exclusion criteria
* Children with an enamel defect that is not typical of MIH. Comparison-group specific exclusion criteria
* Children with an atypical pattern of dental caries/extraction in their first permanen…
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
Prevalence of a dental anomaly in children with and without MIH
Timeframe: recruitment until July 2023
Trial details
NCT IDNCT05812690
SponsorSheffield Teaching Hospitals NHS Foundation Trust