An interventional study of Graphene-reinforced CAD/CAM polymer (G-CAM®) in Tooth Demineralization, Tooth Sensitivity and Enamel Mineralization Disorders, sponsored by Universitat Internacional de Catalunya. Not yet recruiting at 1 site in Spain. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
27 studies on the registry are indexed under Tooth Demineralization; 9 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 27 interventional studies indexed under Tooth Demineralization.
Browse Tooth Demineralization studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Use of analgesics/AINEs \<24 h before baseline VAS.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 12 months after restoration placement
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.
Time frame: Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months
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.
Time frame: 1 month, 3 months, 6 months, and 12 months
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.
Time frame: Baseline and 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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