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

Starting soon · Not applicable

Conditions studied: Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations, Tooth Eruption Disorder, Indirect Restoration

In brief

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.

Key facts

Study ID

NCT07329244

Run by

Universitat Internacional de Catalunya

People needed

30

Starts

2026-01-10

Expected to finish

2027-01-11

Last updated by the study team

2026-01-09

Who can join

Age: 10 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adolescents aged 10-16 years.
• Permanent molars with moderate or severe MIH (EAPD criteria).
• Vital and restorable teeth.
• Ability to attend follow-up visits.
• Informed consent from guardian + assent from the minor.

You may not qualify if…

• Fluorosis, amelogenesis imperfecta, or other enamel defects.
• Severe bruxism not controlled.
• Active extensive caries or irreversible pulpitis.
• Systemic conditions affecting enamel or healing.
• Hypersensitivity/allergy to materials/adhesives.
• Use of analgesics/AINEs <24 h before baseline VAS.
• Orthodontic bands on the study molar.

Where it is running

• Dental Esthetic BCN — Sarrià-Sant Gervasi, Barcelona, Spain

Full record on ClinicalTrials.gov

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