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Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Sponsor: Çanakkale Onsekiz Mart University
Summary
The purpose of this randomized clinical trial is to compare the clinical performance and survival of two restorative systems in permanent first molars affected by molar-incisor hypomineralization (MIH) in children aged 8 to 14 years. MIH is a developmental condition that affects the enamel of permanent first molars and may also affect permanent incisors. Affected molars may develop enamel breakdown, sensitivity, and dental caries and may require restorative treatment. Children included in the study will have at least two MIH-affected permanent first molars that require direct restorative treatment. In each child, one eligible tooth will be restored with the glass hybrid restorative system EQUIA Forte HT, and the other eligible tooth will be restored with the alkasite restorative system Cention Forte. The restorative system assigned to each tooth will be determined at random. Restorative treatment will be performed after selective caries removal and under rubber dam isolation. Researchers will compare the two restorations within the same child over time. The restorations will be evaluated for clinical performance and restoration survival. Follow-up assessments will be performed at 1, 3, 6, 12, 18, 24, and 36 months after treatment.
Official title: Comparison of the Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in Permanent First Molars Affected by Molar-Incisor Hypomineralization: A Split-Mouth Randomized Clinical Trial
Key Details
Gender
All
Age Range
8 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-12-31
Completion Date
2030-06-30
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Alkasite Restorative System
Cention Forte will be used with Cention Primer for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Primer application, material preparation and placement, polymerization/setting, finishing, and polishing will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session.
Glass Hybrid Restorative System
EQUIA Forte HT will be used with EQUIA Forte Coat for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Material preparation and placement, setting, finishing, and application of the surface coating will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session.
Locations (1)
Çanakkale Onsekiz Mart University
Çanakkale, Kepez, Turkey (Türkiye)