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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Health Around Stainless Steel Crowns | 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 month (single clinical assessment at follow-up visit) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Başak Günay, DDS | Bezmialem Vakıf University Faculty of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakıf University Faculty of Dentistry | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42332667 | Derived | Gunay B, Soylu N, Bayram M. Clinical outcomes and parental of two stainless steel crown systems in pediatric patients: a retrospective observational cohort study. BMC Oral Health. 2026 Jun 23. doi: 10.1186/s12903-026-08998-w. Online ahead of print. |
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Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to patient confidentiality.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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. |
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| Parental Satisfaction with Stainless Steel Crowns | 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) |