Enamel Mineralization Disorders, Indirect Restoration, Tooth Demineralization, Tooth Eruption Disorder, Tooth Sensitivity, Tooth Sensitivity After Composite Restorations
Conditions
Keywords
molar-incisor hypomineralization, MIH, enamel defects, indirect restorations, minimally invasive dentistry, adhesive dentistry
Brief summary
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
DEVICEGraphene-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.
Sponsors
Clínica Odontologica de la Universidad de Barcelona ( UB)
Universitat Internacional de Catalunya
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score | 12 months after restoration placement | 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) | Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Measured by 5-Point Likert Scale | 1 month, 3 months, 6 months, and 12 months | 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) | Baseline and 12 months | 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. |
Countries
Spain
Contacts
Primary ContactLuis Carlos Garza Garza
Outcome results
None listed