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

NCT ID: NCT07336212

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-01

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.

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.

Conditions

Molar-Incisor Hypomineralization (MIH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Glass-Hybrid Restoration

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 -

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Pedo-occlusion

Identifier Type: -

Identifier Source: org_study_id