Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glass Hybrid Restorative Treatment.
- Who it may be relevant to
- Registry conditions: Molar-Incisor Hypomineralization (MIH), Masticatory Performance, Occlusal Analysis, Chewing Function. Basic parameters: 7 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Occlusal Force Distribution and Masticatory Function Before and After Restorative Treatment in Children With Molar-Incisor Hypomineralization
Overview
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.
Interventions
- Procedure Glass Hybrid Restorative Treatment
Restorative treatment of MIH-affected molars using glass hybrid restorative material to evaluate changes in occlusal force distribution and chewing function.
Primary outcome measures
- Percentage of Occlusal Force Distribution Between Right and Left Sides [Time frame: Baseline and 3 months after restorative treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07589179 · pedo-TO · 09.2024.806