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

NCT07393854 | Completed FDA Device

• 1 other identifier: 08.06.2023-E.110543
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; General Anesthesia; Pediatric Dentistry

Keywords

steenless steel crown; pediatric dental treatments; general anesthesia; restorative dental treatments

Outcome Measures

Primary Outcomes (1)

• Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)

  Overall clinical success will be defined as the presence of a clinically acceptable stainless steel crown at follow-up, based on a composite assessment of predefined clinical parameters. A crown will be considered clinically successful only if all criteria listed below are met. Clinical success criteria include: Crown retention (present) Occlusal contact (present) Proximal contact adaptation (acceptable) Absence of crown perforation Absence of pain or swelling Absence of fistula formation Absence of tenderness to percussion Absence of pathological tooth mobility Gingival health score ≤1 on the Gingival Index Unit of Measure: Binary outcome (Successful / Unsuccessful)

  1 month (single follow-up assessment for all participants with a minimum of 6 months postoperative period)

Secondary Outcomes (2)

• Gingival Health Around Stainless Steel Crowns

  1 month (single clinical assessment at follow-up visit)

• Parental Satisfaction with Stainless Steel Crowns

  1 month (single questionnaire-based assessment at follow-up visit)

Study Arms (2)

Nu Smile Group

This group consists of pediatric patients aged 2-8 years who have received Nu Smile stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction.

Device: NuSmile Stainless Steel Crown

Kids Crown Group

This group consists of pediatric patients aged 2-8 years who have received Kids Crown stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction.

Device: Kids Crown Stainless Steel Crown

Interventions

Kids Crown Stainless Steel Crown DEVICE

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.

Kids Crown Group

NuSmile Stainless Steel Crown DEVICE

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.

Nu Smile Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will include pediatric patients aged 2-8 years who have previously undergone stainless steel crown restorations under general anesthesia. Only patients with a minimum postoperative period of 6 months will be included. The study aims to evaluate clinical success and parental satisfaction regarding these restorations.

You may qualify if:

• Children aged 2-8 years
• Have received at least one stainless steel crown restoration under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry
• Have a minimum postoperative period of 6 months
• Parents provided written informed consent

You may not qualify if:

• Children whose parents did not provide written consent
• Children with chronic systemic diseases
• Children with physical or mental disabilities

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University Faculty of Dentistry

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Başak Günay, DDS

  Bezmialem Vakıf University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 6, 2026
• Study Start: June 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)