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

NCT07336212 | Recruiting

• 1 other identifier: Pedo-occlusion
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Molar-Incisor Hypomineralization (MIH)

Keywords

Pediatric Dentistry; MIH; Occlusal Balance; Electromyography; T-Scan; sEMG; Molar-Incisor Hypomineralization; Occlusal Force Distribution; Glass-Hybrid Restoration

Outcome Measures

Primary Outcomes (1)

• Lateral Occlusal Force Distribution (LOFD)

  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 Outcomes (2)

• Masticatory Muscle Activity Symmetry

  Baseline and 3 months post-treatment

• Dentin Hypersensitivity

  Baseline and 3 months post-treatment

Study Arms (1)

Glass-Hybrid Restoration in MIH-Affected Molars

EXPERIMENTAL

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

Interventions

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.

Glass-Hybrid Restoration in MIH-Affected Molars

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

COMPLETED

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: January 10, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 20, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)