CompletedNot Applicable

Clinical Evaluation of Nanoionomer Filling in Primary Teeth

Egypt29 participantsStarted 2011-06

Plain-language summary

This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).

Who can participate

Age range

5 Years – 8 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: * The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction). Exclusion Criteria: * Handicapped or uncooperative children and children with extensive or rampant caries.

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

Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries.

Timeframe: 2 years

Trial details

NCT IDNCT02093091

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More Dental Caries trials