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.

This is a prospective, single-arm, monocentric clinical trial designed to assess the functional performance, marginal adaptation, wear behavior, postoperative sensitivity, and structural preservation of graphene-reinforced CAD/CAM restorations placed on MIH-affected molars in adolescents aged 10-16 years. MIH lesions present compromised enamel quality with increased porosity, susceptibility to post-eruptive breakdown, and frequent hypersensitivity, making conventional restorative approaches less predictable.

Minimally invasive preparations will be performed followed by adhesive placement of graphene-reinforced CAD/CAM indirect restorations fabricated through a fully digital workflow (intraoral scanning, CAD design, CAM milling). Evaluations will be performed at baseline, 48 h, 1, 3, 6, and 12 months. Primary variables include global and domain-specific FDI clinical scores (marginal integrity, surface roughness, color stability, fractures/chipping, proximal contact, occlusion/function, soft tissue response) and postoperative sensitivity measured using a Visual Analog Scale (VAS). Secondary outcomes include patient satisfaction, tooth vitality, digital volumetric analysis of structural preservation, survival of restorations, and efficiency of the digital workflow.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Individual participant data (IPD) will not be shared with other researchers. The study involves pediatric participants, and all data will be pseudonymized and stored in secure, access-restricted servers according to GDPR and local ethics requirements. Because the dataset is small, contains sensitive clinical information from minors, and is collected within a single clinical center, sharing IPD may increase the risk of re-identification. Therefore, IPD will not be made available outside the research team.