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

NCT07589179 | Not Yet Recruiting

• 2 other identifiers: pedo-TO09.2024.806
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Molar-Incisor Hypomineralization (MIH); Chewing Function; Occlusal Analysis; Masticatory Performance

Outcome Measures

Primary Outcomes (1)

• Right-Left Occlusal Force Distribution

  Occlusal force distribution between the right and left sides will be evaluated using a digital occlusal analysis system before and after restorative treatment in children with MIH.

  Baseline and 3 months after restorative treatment

Study Arms (2)

MIH Restorative Treatment Group

EXPERIMENTAL

Children with molar-incisor hypomineralization (MIH) will receive glass hybrid restorative treatment. Occlusal force distribution and chewing function will be evaluated before and after treatment using digital occlusal analysis and a chewing gum protocol.

Procedure: Glass Hybrid Restorative Treatment

Healthy Control Group

NO INTERVENTION

Healthy children without MIH will undergo occlusal force distribution and chewing function assessments for comparison with the MIH group. No restorative intervention will be performed.

Interventions

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.

MIH Restorative Treatment Group

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Afra Nur Savas

CONTACT

+90 534 327 92 74; aafranursavas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05