CompletedPhase 4

Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children

Egypt14 participantsStarted 2022-11-01

Plain-language summary

This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.

Who can participate

Age range

8 Years – 14 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: * Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I). * Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index. * Maxillary and mandibular permanent anterior teeth Exclusion Criteria: * Refusal of the parents to sign the informed consent. * Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth. * Enamel hypomineralization

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

Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.

Timeframe: every 6months for 2 years

Trial details

NCT IDNCT06205420

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Enamel Hypoplasia trials