Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypominerali… (NCT07589179) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization
68 participantsStarted 2026-05-11
Plain-language summary
This study aims to evaluate right-left chewing balance and masticatory function in children with Molar-Incisor Hypomineralization (MIH) before and after restorative treatment. MIH is a developmental enamel defect that may cause tooth sensitivity, discomfort during chewing, and functional asymmetry.
Children aged 7 to 12 years with bilateral MIH affecting the first permanent molars will receive glass hybrid restorative treatment. Right-left occlusal force distribution will be assessed using a digital occlusal analysis system. In addition, chewing side preference and chewing balance will be evaluated using a standardized chewing gum protocol. These two assessment methods will be used together to provide complementary information about masticatory function.
Measurements will be performed before treatment and during follow-up visits after treatment. The findings obtained from children with MIH will also be compared with healthy children without MIH. The study aims to determine whether restorative treatment improves chewing balance and functional oral performance in children with MIH.
Who can participate
Age range
7 Years – 13 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 aged 7 to 12 years
* Presence of bilateral molar-incisor hypomineralization (MIH) affecting first permanent molars
* Need for restorative treatment in MIH-affected molars
* Cooperative children with sufficient cognitive ability to complete functional assessments
* Presence of healthy control participants without MIH for comparison
* Mixed dentition period
* Signed informed consent obtained from parents or legal guardians
Exclusion Criteria:
* Temporomandibular disorders or orofacial pain
* Systemic diseases or regular medication use affecting mastication
* History of orthodontic treatment or parafunctional habits
* Craniofacial anomalies or developmental dental anomalies
* Extensive prosthetic restorations affecting chewing function
* Uncooperative children unable to complete examination procedures
* Acute dental infection or pain requiring emergency 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
Percentage of Occlusal Force Distribution Between Right and Left Sides
Timeframe: Baseline and 3 months after restorative treatment