Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars (NCT06450093) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars
Egypt51 participantsStarted 2024-04-04
Plain-language summary
This study will be conducted to:
Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.
Who can participate
Age range
4 Years – 7 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:
* Children who are free from any systemic disease.
* Children with a carious lower primary molar indicated for crown restoration.
* Teeth with an intact antagonist and neighboring primary molar.
* Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.
Exclusion Criteria:
* Children with extremely poor oral hygiene.
* Teeth showing radiographical furcation involvement or root resorption.
* Children with para-functional habits, bruxism, or deep bite.
* Teeth with inadequate non-restorable crown structure.
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.