CompletedNot Applicable

Impact of Glass-Hybrid Restoration on Occlusal Force Distribution and Masticatory Muscle Activity in Children With Molar-Incisor Hypomineralization

Turkey (Türkiye)5 participantsStarted 2026-01-05

Plain-language summary

This prospective pilot study evaluates the effect of restoring symptomatic, carious molar-incisor hypomineralization (MIH)-affected permanent molars using a glass-hybrid restorative material on occlusal force distribution and masticatory muscle activity. Digital occlusal analysis using the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles are performed before treatment and three months after restoration. Hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale.

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 13 years * Diagnosis of molar-incisor hypomineralization (MIH) according to the criteria of Ghanim et al. * Presence of at least two MIH-affected first permanent molars with post-eruptive enamel breakdown requiring restorative treatment * Presence of dentin hypersensitivity in the affected molars * Ability to comply with T-Scan and surface electromyography (sEMG) recording procedures * Written informed consent obtained from parents or legal guardians, and assent from the child * Exclusion Criteria: * Previous or ongoing orthodontic treatment * Presence of craniofacial anomalies or syndromes * Diagnosis of temporomandibular disorders * Parafunctional habits (e.g., bruxism) * Clinically evident facial asymmetry * Malocclusions such as crossbite or open bite * Systemic diseases or medications affecting neuromuscular function -Inability to cooperate with functional assessment procedures -

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

Lateral Occlusal Force Distribution (LOFD)

Timeframe: Baseline and 3 months post-treatment

Trial details

NCT IDNCT07336212

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Molar-Incisor Hypomineralization (MIH) trials