Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars (NCT06968767) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
Egypt22 participantsStarted 2025-06-15
Plain-language summary
This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.
• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.
• Secondary Objectives:
To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:
Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.
the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?
Who can participate
Age range
4 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:
* Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.
Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
Children whose parent or guardian is willing to sign an informed consent.
Children whose parent or guardian are willing to comply with follow-up visits.
Frankl's positive and definitely positive patient.
Exclusion Criteria:
* Molars with severe structural loss that may compromise crown retention.
Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.
Children with any systemic conditions or disabilities that may affect their ability to participate in the study.
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
prepration time
Timeframe: time frame: T0: 0 basline, follow up 12 month