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Completed

NCT Number: NCT07336212

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

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.

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 -

Treatment and study plan

Glass-Hybrid Restoration

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
May 12, 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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