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Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 9, 2026 (before its estimated April 23, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This study evaluates the clinical performance, marginal integrity, surface wear, color stability, and postoperative sensitivity of graphene-reinforced CAD/CAM indirect restorations (inlays, onlays, overlays) in molars affected by moderate to severe Molar-Incisor Hypomineralization (MIH) in adolescents. A total of 30 patients aged 10-16 years will receive minimally invasive indirect restorations fabricated from a nano-reinforced graphene polymer (G-CAM®). Clinical outcomes will be assessed using FDI criteria, VAS sensitivity scores, patient satisfaction, and digital 3D scans over a 12-month follow-up. The study aims to determine clinical acceptability and safety compared with historical outcomes reported for composite and lithium-disilicate indirect restorations.
Trial Details
NCT Number NCT07329244
Lead Sponsor Universitat Internacional de Catalunya
Collaborators: Clínica Odontologica de la Universidad de Barcelona ( UB)
Conditions
(from sponsor)		 Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations, Tooth Eruption Disorder, Indirect Restoration
Related terms Dentin Sensitivity, Molar Hypomineralization, Tooth Demineralization
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov