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

May 11, 2026 updated by: Marmara University

Impact of Restorative Treatment on Occlusal Characteristics and Masseter Muscle Activity in Children With Molar-Incisor Hypomineralization: A T-Scan and sEMG Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-arm prospective pilot study investigates whether restorative rehabilitation of MIH-affected permanent molars leads to functional improvements in occlusal balance and neuromuscular activity. Children aged 7-13 years with symptomatic MIH requiring restorative treatment undergo standardized glass-hybrid restorations. Functional occlusal analysis is conducted using the T-Scan Novus system to assess lateral occlusal force distribution, while bilateral surface electromyography (sEMG) evaluates masseter and temporalis muscle activity during maximum voluntary clenching. Dentin hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale. Pre- and post-treatment outcomes are compared to explore early functional adaptation following MIH rehabilitation.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkey (Türkiye), 34854
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass-Hybrid Restoration in MIH-Affected Molars
Participants receive restorative treatment of symptomatic, carious first permanent molars affected by molar-incisor hypomineralization using a bulk-fill glass-hybrid restorative material (Equia Forte®). Functional assessments, including digital occlusal analysis with the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles, are performed at baseline and 3 months after restoration.
Procedure: Glass-Hybrid Restoration
Selective caries removal followed by bulk-fill glass-hybrid restoration of MIH-affected first permanent molars using Equia Forte®. The procedure is performed by a calibrated pediatric dentist according to the manufacturer's instructions. Occlusion is checked and adjusted after restoration prior to functional assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral Occlusal Force Distribution (LOFD)
Time Frame: Baseline and 3 months post-treatment
Change in lateral occlusal force distribution assessed using the T-Scan digital occlusal analysis system during maximum voluntary clenching. The primary variable is the absolute deviation from ideal 50-50 bilateral force distribution, calculated at baseline and 3 months after glass-hybrid restoration.
Baseline and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Masticatory Muscle Activity Symmetry
Time Frame: Baseline and 3 months post-treatment
right-left asymmetry indices of the masseter and anterior temporalis muscles measured using surface electromyography (sEMG) during maximum voluntary clenching.
Baseline and 3 months post-treatment
Dentin Hypersensitivity
Time Frame: Baseline and 3 months post-treatment
Dentin hypersensitivity of MIH-affected molars assessed using the Schiff Cold Air Sensitivity Scale following an air-blast stimulus.
Baseline and 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

May 4, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pedo-occlusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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