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临床试验/NCT07393854
NCT07393854已完成不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: NuSmile Stainless Steel Crown (Device)

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.

干预措施: Kids Crown Stainless Steel Crown (Device)

结局指标

主要结局

Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)

时间窗: 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)

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Narmin Mammadli

Principal Investigator

Bezmialem Vakif University

研究点 (1)

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