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

February 3, 2026 updated by: Narmin Mammadli, Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Bezmialem Vakıf University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)
Time Frame: 1 month (single follow-up assessment for all participants with a minimum of 6 months postoperative period)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Health Around Stainless Steel Crowns
Time Frame: 1 month (single clinical assessment at follow-up visit)

Gingival health will be assessed using the Gingival Index (Löe and Silness) to evaluate inflammation of the gingival tissues adjacent to the crowns.

Scale:

Gingival Index (GI):

0 = Normal gingiva

  1. = Mild inflammation
  2. = Moderate inflammation
  3. = Severe inflammation Higher scores indicate worse gingival health.
1 month (single clinical assessment at follow-up visit)
Parental Satisfaction with Stainless Steel Crowns
Time Frame: 1 month (single questionnaire-based assessment at follow-up visit)

Parental satisfaction will be assessed using a structured questionnaire based on a 5-point Likert scale, evaluating parental perception of the stainless steel crowns.

Domains assessed include:

Aesthetic satisfaction (color, appearance, shape, size) Functional satisfaction (durability, retention, comfort) Overall acceptance and parental preference

Scale:

5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) Higher scores indicate greater parental satisfaction.
1 month (single questionnaire-based assessment at follow-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Başak Günay, DDS, Bezmialem Vakıf University Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.06.2023-E.110543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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