Not Yet RecruitingNot Applicable

Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers

Egypt50 participantsStarted 2024-12-01

Plain-language summary

To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars. A Randomized Clinical Trial

Who can participate

Age range

4 Years – 6 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: * Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy. * Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period. * Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior. * According to space analysis, available space is less than or equal to the needed space * 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars * Children are mentally capable of communication. * Children aged 4-6 years Exclusion Criteria: * Children with any parafunctional habits. * Children with previous allergies to stainless steel. * Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer. * Parental refusal of participation.

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

Gingival Health

Timeframe: 3 month and 9 month

Cement integrity

Timeframe: 3 month and 9 month

Trial details

NCT IDNCT06573463

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Lamis A Badawi

02001221184776 lamis.abdelkhale@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Premature Tooth Exfoliation trials

Who can participate

Age range

4 Years – 6 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.