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NCT Number: NCT07589179

Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glass Hybrid Restorative Treatment

Procedure

Restorative treatment of MIH-affected molars using glass hybrid restorative material to evaluate changes in occlusal force distribution and chewing function.

Primary outcomes

  1. Percentage of Occlusal Force Distribution Between Right and Left Sides

    Time frame: Baseline and 3 months after restorative treatment

    Percentage distribution of occlusal force between the right and left sides and chewing side assessed using a chewing gum test will be evaluated before and after restorative treatment in children with MIH using a digital occlusal analysis system.

Study contacts

Contact information is provided by the study sponsor or research team.

Afra Nur Savas

CONTACT

[email protected]

+90 534 327 92 74

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Occlusal Force Distribution and Masticatory Function Before and After Restorative Treatment in Children With Molar-Incisor Hypomineralization

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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