Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Cl… (NCT07329244) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study
Spain30 participantsStarted 2026-01-10
Plain-language 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.
Who can participate
Age range
10 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score
Timeframe: 12 months after restoration placement
2
Postoperative Sensitivity Measured by Visual Analog Scale (VAS 0-10)