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.
Study 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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Dental Esthetic BCN
Sarrià-Sant Gervasi
Barcelona
More Universitat Internacional de Catalunya trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
