Clinical Trial

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

Not Yet Recruiting

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.

Summary

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	Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations, Tooth Eruption Disorder, Indirect Restoration
Enrollment	30 participants
Start Date	2026-01-10
Primary Completion	2026-04-23 (estimated)
Study Completion	2027-01-11 (estimated)
Updated on ClinicalTrials.gov	2026-01-09