Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization (NCT06692257) | Clinical Trial Compass
CompletedNot Applicable
Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization
Brazil56 participantsStarted 2025-03-01
Plain-language summary
Molar incisor hypomineralization (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component that predominantly affects the permanent first molars and, occasionally, the permanent incisors. Individuals with MIH may present a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge regarding the specific functional abnormalities experienced by these individuals. The aim of this study was to perform a comparative analysis of orofacial functions, with emphasis on breathing and chewing patterns, in individuals with and without MIH. Assessments were performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive statistics were conducted, and comparisons were performed using the chi-square test, adopting a 5% significance level.
Who can participate
Age range
6 Years – 12 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.
Inclusion Criteria:
* Children 6 to 12 years of age with a complete mixed dentition with all first molars present and in occlusion;
* Having all first molars erupted, without caries or previous treatment;
* Inclusion criteria for the MIH group: at least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria).
Exclusion Criteria:
* Children with amelogenesis and dentinogenesis imperfecta;
* Children undergoing orthodontic treatment;
* Children with a genetic syndrome;
* Children with the premature loss of deciduous teeth;
* Children with acute respiratory problems;
* Children in treatment.
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
Assessment of orofacial function (NOT-S) - (score from 0 to 12)