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

Universitat Internacional de Catalunya

Status: Not yet enrolling

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

Treatments: Device: Graphene-reinforced CAD/CAM polymer (G-CAM®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07329244

64/2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Graphene-Reinforced CAD/CAM Indirect Restoration

Experimental group

Description:

Minimally invasive preparation, composite base build-up when indicated, adhesive protocol with total-etch technique, CAD/CAM fabrication using graphene-reinforced polymer (G-CAM®), adhesive cementation under rubber dam isolation, finishing and polishing, and follow-up at 1 week, 3, 6, and 12 months.

Treatment:

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