Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study

Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Demineralization; Tooth Sensitivity; Tooth Eruption Disorder; Tooth Sensitivity After Composite Restorations; Enamel Mineralization Disorders; Indirect Restoration
• Intervention / Treatment: Device: Graphene-reinforced CAD/CAM polymer (G-CAM®)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Carlos Garza Garza; Phone Number: +34938732017; Email: luiscarlos@UIC.es

Study Locations

• Spain
  • Barcelona
    • Sarrià-Sant Gervasi, Barcelona, Spain, 08034
      • Dental Esthetic BCN
      • Contact: Luis Carlos Garza Garza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graphene-Reinforced CAD/CAM Indirect Restoration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: = Clinically excellent (best outcome); = Clinically good; = Clinically acceptable; = Clinically unsatisfactory; = 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.	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.	Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: = Very dissatisfied (worst outcome); = Dissatisfied; = Neutral; = Satisfied; = Very satisfied (best outcome) Higher scores indicate higher satisfaction.	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.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Clínica Odontologica de la Universidad de Barcelona ( UB)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2026
• Primary Completion (Estimated): April 23, 2026
• Study Completion (Estimated): January 11, 2027

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: MIH; minimally invasive dentistry; molar-incisor hypomineralization; enamel defects; indirect restorations; adhesive dentistry
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Molar Hypomineralization; Dentin Sensitivity; Tooth Demineralization
• Other Study ID Numbers: 64/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No