Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomize… (NCT07738471) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars
64 participantsStarted 2026-11
Plain-language summary
Early childhood caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Zirconia crowns have become a popular esthetic restorative option; however, limited evidence is available regarding the clinical performance of custom-made zirconia crowns compared with prefabricated zirconia crowns. This randomized controlled clinical trial aims to compare the clinical performance of custom-made and prefabricated zirconia crowns placed on pulpotomized primary molars. Clinical performance will be evaluated using standardized clinical and radiographic outcome measures over the follow-up period to determine whether custom-made zirconia crowns provide comparable or improved outcomes.
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:
* Children aged 5-8 years.
* Primary molars with deep carious lesions extending to the middle third of the dentin as confirmed radiographically.
* Absence of root caries.
* Absence of periapical or inter-radicular radiolucency.
* Absence of internal or external root resorption.
* Teeth in the opposite arch are present and in normal occlusion.
* Willingness to participate and adhere to the follow-up appointments
Exclusion Criteria:
* Children with systemic health issues.
* Children with periodontal diseases.
* Children exhibiting parafunctional habits.
* Uncooperative children (Frankl scale (score 1 and 2).
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.