NCT07426445

CLINICAL PERFORMANCE OF PEDIATRIC CROWNS IN PRIMARY MOLAR

Comparative Evaluation Of The Clinical Success Of Prefabricated Nanohybrid Composite, Zirconia, And Stainless Steel Crowns In Primary Teeth: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dental Caries in Primary Teeth
• Full-Coverage Restorations in Pediatric Dentistry

Interventions

Type	Name	Description
DEVICE	Prefabricated Zirconia Crown	Prefabricated zirconia crowns are used for full coronal restoration of mandibular second primary molars.
DEVICE	Prefabricated Nanohybrid Composite Crown	Prefabricated nanohybrid composite crowns are used for full coronal restoration of mandibular second primary molars.

Timeline

• Start date: 2025-01-11
• Primary completion: 2026-01-11
• Completion: 2026-01-11
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Turkey (Türkiye)