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临床试验/NCT07312539
NCT07312539已完成不适用

The Influence of Potential Risk Factors on the Long-Term Success of Mineral Trioxide Aggregate Pulpotomy in Primary Teeth

Sümeyra Akkoç2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Clinical outcome

研究概览

简要总结

The goal of this observational study is to learn about the long-term results of Mineral Trioxide Aggregate (MTA) pulpotomy in primary molars and the factors that may affect treatment success.

The main question it aims to answer is:

Do clinical, operator and restoration-related factors influence the long-term success of MTA pulpotomy in primary molars?

In this study, children who received MTA pulpotomy treatment were examined at the 24-month follow-up visit, scheduled at the beginning of the study. Two examiners checked the clinical condition of the teeth, and two other examiners reviewed the radiographs without knowing the clinical results.

详细描述

This cross-sectional observational study was conducted to evaluate the 24-month clinical and radiographic outcomes of Mineral Trioxide Aggregate (MTA) pulpotomy in primary molars and to identify potential risk factors associated with treatment failure. The study included 152 primary molars from 90 children who met the inclusion criteria and were invited to the 24-month follow-up visit scheduled at the beginning of the study. At this visit, two clinical examiners assessed the clinical condition of the teeth, and two radiographic examiners, blinded to the clinical data, evaluated the radiographic outcomes.

Clinical and radiographic findings were scored based on criteria originally established by Zurn and Seale, subsequently adapted by Rajasekharan et al., and recently by Cordell et al. The risk factors that could have influenced treatment failure were also documented, including arch type (maxillary or mandibular), tooth type (first or second primary molar), side (right or left), number of restored surfaces, and restoration quality. Restoration quality was assessed using the modified FDI criteria assessing esthetic, functional, and biological properties.

研究设计

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

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy children
  • Complete preoperative clinical and radiographic records available
  • No additional treatment performed on the treated tooth after the initial MTA pulpotomy
  • Attendance at the 24-month follow-up appointment
  • Willingness to participate in the study
  • Positive or definitely positive behavior during the clinical examination at the 24-month follow-up visit (Frankl Behavior Rating Scale: + or ++)

排除标准

  • Teeth that had exfoliated or received treatment at another center during the follow-up period

结局指标

主要结局

Clinical outcome

时间窗: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.

Clinical outcome was evaluated at 24 months post-treatment by clinical examination using the standardized criteria defined by Zurn and Seale. Scores of 1-2 were classified as treatment success and scores of 3-4 as treatment failure, and results were reported as the proportion of teeth with clinical success (%).

Radiographic outcome

时间窗: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.

Radiographic outcome was evaluated at 24 months post-treatment by clinical examination using the standardized criteria defined by Zurn and Seale. Scores of 1-2 were classified as treatment success and scores of 3-4 as treatment failure, and results were reported as the proportion of teeth with clinical success (%).

次要结局

未报告次要终点

研究者

发起方
Sümeyra Akkoç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sümeyra Akkoç

Assistant Professor, DDS

Kutahya Health Sciences University

研究点 (2)

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