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NCT07426445
CLINICAL PERFORMANCE OF PEDIATRIC CROWNS IN PRIMARY MOLAR
NA trial testing Prefabricated Zirconia Crown in Dental Caries in Primary Teeth in 46 participants. Completed in 11 January 2026.
11 January 2026
Quick facts
| Lead sponsor | Izmir Katip Celebi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 11 January 2025 |
| Primary completion | 11 January 2026 |
| Estimated completion | 11 January 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Prefabricated Zirconia Crown
- Prefabricated Nanohybrid Composite Crown
Conditions studied
- Dental Caries in Primary Teeth — all drugs for Dental Caries in Primary Teeth →
- Full-Coverage Restorations in Pediatric Dentistry — all drugs for Full-Coverage Restorations in Pediatric Dentistry →
Sponsor
Izmir Katip Celebi University
Who can join
Adults 4 to 9, any sex, with Dental Caries in Primary Teeth or Full-Coverage Restorations in Pediatric Dentistry. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to compare the clinical success of three different types of prefabricated crowns commonly used in primary molar teeth: nanohybrid composite crowns, zirconia crowns, and stainless steel crowns. Primary molar teeth play a critical role in supporting growth and development by facilitating mastication and nutrition and by maintaining space for the eruption of permanent successor teeth. Current guidelines in pediatric dentistry recommend stainless steel crowns for the restoration of primary molars with extensive carious lesions. However, increasing esthetic demands have led to the development and growing use of alternative crown systems, such as zirconia and nanohybrid composite crowns. This study will be conducted on 50 children aged 4 to 9 years who present to the Department of Pediatric Dentistry at Izmir Katip Celebi University Faculty of Dentistry, have no systemic diseases, and have no known allergies to local anesthetic agents. Children presenting with carious lesions affecting both mandibular second primary molars will be included. Clinically, teeth with International Caries Detection and Assessment System (ICDAS II) scores of 4, 5, and 6 will be eligible. Radiographically, lesions classified as D1-RA3, D2-RB4, and D3-RC5 will be included. The study will be designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly allocated into two groups: in one group, prefabricated zirconia crowns and stainless steel crowns will be placed, while in the other group, nanohybrid composite crowns and stainless steel crowns will be applied. The primary outcome of the study is to evaluate and compare the clinical success of the three crown types at 3, 6, 9, and 12 months following treatment based on functional, esthetic, and biological criteria. Functional outcomes will include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic outcomes will be assessed in terms of surface roughness, color match, and anatomical form. Biological outcomes will include periodontal health. As a secondary outcome, parental satisfaction will be evaluated to assess perceptions of treatment success and factors influencing crown preference. The results of this study are expected to provide valuable clinical evidence to guide the selection of the most appropriate prefabricated crown type for primary molars in pediatric dentistry.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07426445
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Prefabricated Zirconia Crown
Trials testing the same drug.
- NCT07436325 — Gingival Health After Zirconia Versus Stainless Steel Crowns in Children · NA · not yet recruiting
Other Izmir Katip Celebi University trials
Trials by the same sponsor.
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- NCT07304661 — Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07426445 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Izmir Katip Celebi University
- Last refreshed: 23 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07426445.
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