Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07329244

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tooth Demineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Dentin Sensitivity Developmental Defects of Enamel Enamel Mineralization Disorders Indirect Restoration Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases Tooth Eruption Disorder Tooth Sensitivity Tooth Sensitivity After Composite Restorations

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental Esthetic BCN

Sarrià-Sant Gervasi, Barcelona, 08034, Spain

Location contact

Luis Carlos Garza Garza

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Graphene-reinforced CAD/CAM polymer (G-CAM®)

Device

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 outcomes

  1. Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score

    Time frame: 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:

    • = 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.

  2. 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

    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 outcomes

  1. Patient Satisfaction Measured by 5-Point Likert Scale

    Time frame: 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:

    • = Very dissatisfied (worst outcome)
    • = Dissatisfied
    • = Neutral
    • = Satisfied
    • = Very satisfied (best outcome)

    Higher scores indicate higher satisfaction.

  2. Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Carlos Garza Garza

CONTACT

[email protected]

+34938732017

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

  • Clínica Odontologica de la Universidad de Barcelona ( UB)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.