NCT06685640 Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars
| NCT ID | NCT06685640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aydin Adnan Menderes University |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-07-30 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Kadriye Görkem Ulu Güzel, Doç. Prof.
STUDY DIRECTOR
Adnan Menderes Üniversitesi
Frequently Asked Questions
Who can join the NCT06685640 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 5 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06685640 currently recruiting?
Yes, NCT06685640 is actively recruiting participants. Contact the research team at gorkem.ulu@adu.edu.tr for enrollment information.
Where is the NCT06685640 trial being conducted?
This trial is being conducted at Aydin, Turkey (Türkiye).
Who is sponsoring the NCT06685640 clinical trial?
NCT06685640 is sponsored by Aydin Adnan Menderes University. The principal investigator is Kadriye Görkem Ulu Güzel, Doç. Prof. at Adnan Menderes Üniversitesi. The trial plans to enroll 10 participants.