NCT07329244

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

November 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2027

Expected
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 30, 2025

Last Update Submit

December 28, 2025

Conditions

Tooth DemineralizationTooth SensitivityEnamel Mineralization DisordersTooth Sensitivity After Composite RestorationsTooth Eruption DisorderIndirect Restoration

Keywords

molar-incisor hypomineralizationMIHenamel defectsindirect restorationsminimally invasive dentistryadhesive dentistry

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 Outcomes (2)

  • Patient Satisfaction Measured by 5-Point Likert Scale

    1 month, 3 months, 6 months, and 12 months

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

    Baseline and 12 months

Study Arms (1)

Graphene-Reinforced CAD/CAM Indirect Restoration

EXPERIMENTAL

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®)

Interventions

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.

Graphene-Reinforced CAD/CAM Indirect Restoration

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Esthetic BCN

Sarrià-Sant Gervasi, Barcelona, 08034, Spain

Location

Related Publications (2)

  • 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.

    PMID: 39321762BACKGROUND

  • 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.

    PMID: 34110615BACKGROUND

MeSH Terms

Conditions

Tooth DemineralizationDentin SensitivityMolar Hypomineralization

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesDental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Luis Carlos Garza Garza

CONTACT

+34938732017luiscarlos@UIC.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Restorative and Prosthodontics MSc.

Study Record Dates

First Submitted

November 30, 2025

First Posted

January 9, 2026

Study Start

January 10, 2026

Primary Completion

April 23, 2026

Study Completion (Estimated)

January 11, 2027

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)