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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorUniversitat Internacional de Catalunya

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Universitat Internacional de Catalunya

Lead sponsor

Clínica Odontologica de la Universidad de Barcelona ( UB)

Collaborator