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.
Adolescents aged 10-16 years.
Permanent molars with moderate or severe MIH (EAPD criteria).
Vital and restorable teeth.
Ability to attend follow-up visits.
Fluorosis, amelogenesis imperfecta, or other enamel defects.
Severe bruxism not controlled.
Active extensive caries or irreversible pulpitis.
Systemic conditions affecting enamel or healing.
Single group
Graphene-reinforced CAD/CAM polymer (G-CAM®)
DeviceGraphene-reinforced CAD/CAM polymer (G-CAM®) used for the fabrication of indirect inlay, onlay, or overlay restorations in permanent molars affected by molar-incisor hypomineralization (MIH). Restorations are fabricated using a digital CAD/CAM workflow and adhesively cemented under rubber dam isolation according to the study protocol.
Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score
Clinical performance of the indirect CAD/CAM graphene-reinforced restoration will be evaluated using the FDI World Dental Federation Clinical Criteria. Each domain is scored on a 1-5 ordinal scale, where: 1. = Clinically excellent (best outcome) 2. = Clinically good 3. = Clinically acceptable 4. = Clinically unsatisfactory 5. = Clinically poor (worst outcome) Domains assessed: Marginal integrity Surface roughness/wear Color stability Fractures/chipping Proximal contact Occlusion/function Soft tissue response Higher scores indicate worse clinical performance. Data will be reported as mean score per domain and global acceptability.
Postoperative Sensitivity Measured by Visual Analog Scale (VAS 0-10)
Postoperative sensitivity to cold and mastication will be measured on a 0-10 Visual Analog Scale (VAS), where: 0 = No pain (best outcome) 10 = Worst imaginable pain (worst outcome) Higher scores indicate worse sensitivity.
Patient Satisfaction Measured by 5-Point Likert Scale
Patient satisfaction with the restoration will be measured on a Likert scale from 1 to 5, where: 1. = Very dissatisfied (worst outcome) 2. = Dissatisfied 3. = Neutral 4. = Satisfied 5. = Very satisfied (best outcome) Higher scores indicate higher satisfaction.
Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³)
Structural preservation will be evaluated by comparing preoperative and 12-month postoperative 3D intraoral scans. The primary metric is change in tooth volume (mm³) obtained through digital superimposition. Decreased volume indicates structural loss; minimal change indicates better preservation. Lower volume loss indicates better structural preservation.
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Universitat Internacional de Catalunya
Lead sponsor
Clínica Odontologica de la Universidad de Barcelona ( UB)
Collaborator
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