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临床试验/NCT05810389
NCT05810389已完成4 期

EVALUATION OF AN ALTERNATIVE TECHNIQUE FOR THE APPLICATION OF SODIUM FLUOROPHOSPHATE: A 2-YEARS DOUBLE-BLIND RCT

University of Buenos Aires1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Caries incidence reduction

研究概览

简要总结

he study was designed as a double-blind three-parallel-group randomized controlled trial, in which the evaluators and a researcher, not involved in the evaluation process, was responsible for the randomization process, were masked to the group assignment.

The study will be carried out at 2 schools of the Metropolitan Area of Buenos Aires where school programs are developed by the Department of Preventive and Community Dentistry of the University of Buenos Aires, and that present homogeneous characteristics in terms of social risk. The children (n=244) attending those primary schools will be the population object of the trial.

Clinical examinations

Each child will go under a clinical examination to determine dental status according to the ICDAS II criteria (Pitts, 2005) and the Caries Treatment Need Index (CTNI).

Intervention

Children will be divided into three different groups according to the mode of treatment:

  • NaF varnish group (NaFV) Professional application of 5% NaF varnish twice a year pH 7 (ClinPro White Varnish®) according to manufacturer's instructions.
  • APF in tray Group (APFt) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with tray according to manufacturer's instructions
  • APF in toothbrush group (APFtbru) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with toothbrush 2 minutes brushing according to manufacturer's instructions.

Dental examination and Monitoring

Observations and clinical examinations will be conducted at schools. After 12 and 24 months, the clinical examination will be repeated to assess the dental status of schoolchildren following the same criteria described. The presence of new caries lesions will be taken as a dependent variable. So sound surfaces on baseline will be observed for 24 months.

详细描述

The study was designed as a double-blind three-parallel-group randomized controlled trial, in which the evaluators and a researcher, not involved in the evaluation process, was responsible for the randomization process, were masked to the group assignment.

The study will be carried out at 2 schools of the Metropolitan Area of Buenos Aires where school programs are developed by the Department of Preventive and Community Dentistry of the University of Buenos Aires, and that present homogeneous characteristics in terms of social risk. The children (n=244) attending those primary schools will be the population object of the trial.

All parents/caregivers of the children will receive a leaflet requesting the approval to enroll their children; for those families that decide not to be included into the trial, the children will receive the dental treatment needed but their data will not be evaluated.

The inclusion criteria were children between 4 and 11 years old attending the selected schools. Exclusion criteria: Children with systemic diseases or systemic disease treatments, motor disorders and children receiving preventive measures in other public, private, or social security dental services.

Clinical examinations

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Schoolchildren

排除标准

  • 未提供

研究组 & 干预措施

Varnish

Active Comparator

干预措施: Fluoride (Combination Product)

FFA gel

Active Comparator

干预措施: Fluoride (Combination Product)

FFA toothbrush

Experimental

干预措施: Fluoride (Combination Product)

结局指标

主要结局

Caries incidence reduction

时间窗: 24 months

次要结局

未报告次要终点

研究者

发起方
University of Buenos Aires
申办方类型
Other
责任方
Principal Investigator
主要研究者

ALDO SQUASSI

Chairman Dept. Preventive and Community Dentistry

University of Buenos Aires

研究点 (1)

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