Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Graphene-reinforced CAD/CAM polymer (G-CAM®).
- Who it may be relevant to
- Registry conditions: Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations. Basic parameters: 10 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study
Overview
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.
Detailed 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.
Interventions
- Device Graphene-reinforced CAD/CAM polymer (G-CAM®)
Graphene-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.
Primary outcome measures
- Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score [Time frame: 12 months after restoration placement]
- Postoperative Sensitivity Measured by Visual Analog Scale (VAS 0-10) [Time frame: Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months]
Secondary outcome measures (2)
- Patient Satisfaction Measured by 5-Point Likert Scale [Time frame: 1 month, 3 months, 6 months, and 12 months]
- Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³) [Time frame: Baseline and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Dental Esthetic BCN — Sarrià-Sant Gervasi
Publications
- Mendonca FL, Grizzo IC, Alencar CRB, Rios D. Restorative Therapy of MIH-Affected Molars. Monogr Oral Sci. 2024;32:236-260. doi: 10.1159/000538890. Epub 2024 Jul 1. PMID 39321762
- Somani C, Taylor GD, Garot E, Rouas P, Lygidakis NA, Wong FSL. An update of treatment modalities in children and adolescents with teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2022 Feb;23(1):39-64. doi: 10.1007/s40368-021-00635-0. Epub 2021 Jun 10. PMID 34110615
Identifiers
NCT: NCT07329244 · 64/2025