Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Random… (NCT07156838) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial
Egypt45 participantsStarted 2025-02-10
Plain-language summary
• The goal of this clinical trial is to evaluate the clinical effectiveness of bioflex crowns and zirconia crowns compared to stainless steel crowns when
* restoring primary molars 45 participant who their ages range between 6 and 8 years participated in this study. The participants will be divided into three groups: group (A) for Bioflex crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15).
The periodontal health will be evaluated using gingival index and plaque index .Clinical success will be assessed according to the Modified United States Public Health Service Evaluation (USPHS) criteria regarding: crown retention ,marginal integrity, surface roughness and color change. Moreover, parental and child satisfaction will be evaluated.
Who can participate
Age range
6 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 who are free from any systemic disease.
* Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
* Children with good to fair oral hygiene according to Loe and Silness plaque index.
* Primary molars with deep carious lesion, that are indicated for pulpotomy and crown.
* Primary molars having two-thirds of root structure left radiographically
* Parents' willingness to participate through informed written consent
Exclusion Criteria:
* Children with oral parafunctional habits.
* Primary molars with bifurcation involvement
* Presence of abscess or fistula related to the selected tooth
* Primary molars with insufficient 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.