About this trial
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.
Eligibility criteria
Qualifiers
Adolescents aged 10-16 years.
Permanent molars with moderate or severe MIH (EAPD criteria).
Vital and restorable teeth.
Ability to attend follow-up visits.
Disqualifiers
Fluorosis, amelogenesis imperfecta, or other enamel defects.
Severe bruxism not controlled.
Active extensive caries or irreversible pulpitis.
Systemic conditions affecting enamel or healing.
Trial design
Treatments tested in this trial
- Graphene-reinforced CAD/CAM polymer (G-CAM®)
Treatment groups
Sponsors and collaborators
Universitat Internacional de Catalunya
Lead sponsor
Clínica Odontologica de la Universidad de Barcelona ( UB)
Collaborator