Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars (NCT06685640) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars
Turkey (Türkiye)10 participantsStarted 2024-07-30
Plain-language summary
Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. For a long time, stainless steel crowns have been the restorative material of choice for children's primary and permanent posterior teeth. Today, prefabricated zirconia crowns are more popular than other options because they meet aesthetic expectations and have high mechanical strength. The aim of this study is to evaluate and compare the periodontal health, plaque accumulation, opposing tooth wear, parental satisfaction, and clinical performance (color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity) of pediatric prefabricated stainless steel and zirconia crowns applied after pulpotomy to asymptomatic, multifaceted, deep carious primary mandibular second molars.
Who can participate
Age range
4 Years – 5 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:
* Age range of children from 4 to 5 years.
* Systemically healthy.
* Children who are positive and extremely positive according to the Frankl behavior scale.
* Asymptomatic primary mandibular second molars with multi-surface deep caries requiring pulpotomy treatment.
* No history of spontaneous pain.
* Primary mandibular second molars where bleeding at the pulpotomy site can be controlled within 3 to 5 minutes.
* Having opposing teeth in occlusal contact.
* Patients without any periodontal-related attachment loss.
* Patients without abscesses or fistulas on primary second molars.
* Children who verbally and in writing agree to participate in the study and are willing to attend regular follow-up appointments will be included.
Exclusion Criteria:
* Having a systemic disease.
* Periapical infection, abscess, or mobility in primary second molars.
* Those with active periodontal disease.
* Malocclusion or missing opposing tooth.
* Primary second molars with pathological internal or external resorption.
* Physiological root resorption exceeding 1/3 of the root.
* Children with bruxism or unilateral chewing habits will not be included 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.