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NCT Number: NCT07393854

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

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.

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Key information

Conditions

Dental Caries General Anesthesia Pediatric Dentistry Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakıf University Faculty of Dentistry

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    • = Mild inflammation
    • = Moderate inflammation
    • = Severe inflammation Higher scores indicate worse gingival health.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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