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临床试验/NCT05146479
NCT05146479已完成不适用

A Long-term Retrospective Cohort Study in Children With Autism Spectrum Disorders on the Effectiveness of Dental Sealants and Fluoride Varnish to Prevent the Occurrence of New Caries

University of Milan1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
1
主要终点
Survival rates from dental caries

研究概览

简要总结

The aim of the study is to compare application of sealants together with fluoride varnishes versus only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.

详细描述

The aim of the study is to evaluate if the application of pit and fissure sealants together with fluoride varnishes is more effective than the application of the only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.

Patients with at least 10-year follow-up and ASDs are recruited and allocated to two cohort according to the strategy adopted for prevention of caries in first permanent molars: FA group (only fluoride varnishes) and FA+S group (sealants together with fluoride varnishes).

Caries incidence and sealants retention after the follow-up period are recorded. Demographic and clinical characteristics of patients at first dental visit are also recorded (age, level of cooperation, presence of systemic diseases other than ASDs, caries severity) to evaluate if they play a potential protective and/or risk factors for caries development.

Logistic and multivariate analysis are run to evaluate caries incidence and retention rate of sealants in first permanent molars over a period of at least 10 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age less than 14 years
  • written declaration of informed consent signed by parents/guardians

排除标准

  • incomplete clinical records
  • missing five or more dental check-ups over the follow-up period
  • oral or dental care provided in sedation or general anesthesia
  • follow-up less than 15 years

结局指标

主要结局

Survival rates from dental caries

时间窗: 15 years

Percentage of first permanent molars free from caries

次要结局

  • Survival rates of pit and fissure sealant(15 years)
  • Evaluation of confounders(15 years)

研究者

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

Maria Grazia Cagetti

Prof. Maria Grazia Cagetti

University of Milan

研究点 (1)

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