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NOT YET RECRUITING
NCT07329244
NA

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

Sponsor: Universitat Internacional de Catalunya

View on ClinicalTrials.gov

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.

Official title: Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study

Key Details

Gender

All

Age Range

10 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-10

Completion Date

2027-01-11

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DEVICE

Graphene-reinforced CAD/CAM polymer (G-CAM®)

Graphene-reinforced CAD/CAM polymer (G-CAM®) used for the fabrication of indirect inlay, onlay, or overlay restorations in permanent molars affected by molar-incisor hypomineralization (MIH). Restorations are fabricated using a digital CAD/CAM workflow and adhesively cemented under rubber dam isolation according to the study protocol.

Locations (1)

Dental Esthetic BCN

Sarrià-Sant Gervasi, Barcelona, Spain