NCT07393854

Clinical Success of Two Stainless Steel Crowns in Children Treated Under General Anesthesia

Clinical Success and Parental Satisfaction of Two Commercially Available Stainless Steel Crowns in Pediatric Patients Under General Anesthesia: A Comparative Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems used in pediatric patients treated under general anesthesia. Children aged 2-8 years who received at least one stainless steel crown under general anesthesia with a minimum follow-up period of 6 months will be evaluated. Clinical outcomes will include crown retention, occlusal contact, gingival health, and other crown-related parameters assessed during follow-up examinations. Parental satisfaction regarding aesthetics, function, durability, and overall acceptance of the crowns will be assessed using a structured questionnaire.

Detailed description

This observational clinical study is designed to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems (NuSmile and Kids Crown) placed in pediatric patients treated under general anesthesia. The study population consists of children aged 2-8 years who received at least one stainless steel crown under general anesthesia at the Department of Pediatric Dentistry, Bezmialem Vakıf University, within the previous three years. Only restorations with a minimum postoperative follow-up of 6 months will be evaluated. All clinical examinations will be completed during a defined 1-month assessment period. Clinical evaluations will be performed by a single calibrated examiner to ensure consistency and reduce inter-examiner variability. Examinations will be conducted under standardized dental light conditions using a dental mirror and curved explorer. A structured and previously validated scoring system adapted from the literature will be applied for all clinical assessments. The clinical evaluation will focus on crown-related outcomes, including retention, occlusal contact, proximal contact adaptation, crown integrity, gingival response, and oral hygiene status. Additional clinical signs such as pain, swelling, fistula formation, percussion sensitivity, and tooth mobility will also be recorded to identify potential biological or functional complications associated with the restorations. Parental satisfaction will be assessed using a structured questionnaire administered to parents or legal guardians at the follow-up visit. Satisfaction will be evaluated using a 5-point Likert scale addressing aesthetic appearance, functional performance, durability, and overall acceptance of the stainless steel crowns. Statistical analyses will be conducted to compare clinical outcomes and parental satisfaction between the two crown systems. Appropriate statistical tests will be selected based on data distribution and variable characteristics, with statistical significance set according to conventional thresholds.

Conditions

• Dental Caries
• General Anesthesia
• Pediatric Dentistry

Interventions

Type	Name	Description
DEVICE	NuSmile Stainless Steel Crown	NuSmile stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up.
DEVICE	Kids Crown Stainless Steel Crown	Kids Crown stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-06-15
• Completion: 2025-06-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study