Tooth DemineralizationNCT07329244
Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study
A study testing Graphene-reinforced CAD/CAM polymer (G-CAM®) in people with Tooth Demineralization and Tooth Sensitivity, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders
- What is being tested?
- Graphene-reinforced CAD/CAM polymer (G-CAM®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2026to 11 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Dental Esthetic BCN
Sarrià-Sant Gervasi, Barcelona, 08034
Luis Carlos Garza Garza
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations, Tooth Eruption Disorder, Indirect Restoration
- Being tested
- Graphene-reinforced CAD/CAM polymer (G-CAM®)
- Keywords
- molar-incisor hypomineralization, MIH, enamel defects, indirect restorations, minimally invasive dentistry, adhesive dentistry
- Medical subject headings
- Tooth Demineralization, Dentin Sensitivity, Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Graphene-reinforced CAD/CAM polymer (G-CAM®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion23 Apr 2026 (estimated)
- Study completion11 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth DemineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Odontologica de la Universidad de Barcelona ( UB)
- Responsible party
- Principal investigator, Luis Carlos Garza Garza, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329244
- Sponsor's protocol ID
- 64/2025
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39321762Somani 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.
PubMed 34110615
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study
- ClinicalTrials.gov ID
- NCT07329244
- Acronym / sponsor ID
- 64/2025
- Conditions
- Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations, Tooth Eruption Disorder, Indirect Restoration
- Keywords
- molar-incisor hypomineralization, MIH, enamel defects, indirect restorations, minimally invasive dentistry, adhesive dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Clínica Odontologica de la Universidad de Barcelona ( UB)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 11 Jan 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graphene-Reinforced CAD/CAM Indirect Restoration | Experimental | Device: Graphene-reinforced CAD/CAM polymer (G-CAM®)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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Graphene-Reinforced CAD/CAM Indirect Restoration |
Primary outcome
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: 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)
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.
2 secondary outcomes
Patient Satisfaction Measured by 5-Point Likert Scale
Time frame: 1 month, 3 months, 6 months, and 12 months
Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 39321762Mendonca 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.
- Background: PubMed 34110615Somani 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graphene-reinforced CAD/CAM polymer (G-CAM®) in people with Tooth Demineralization and Tooth Sensitivity, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Carlos Garza Garza (+34938732017, luiscarlos@UIC.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score (time frame: 12 months after restoration placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.