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临床试验/CTRI/2024/08/072304
CTRI/2024/08/072304尚未招募3 期

Comparing the efficacy of four different types of agents for arresting caries in primary teeth -A randomized controlled double blind clinical trial

Manav Rachna Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年8月19日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
240
试验地点
1
主要终点
Caries arrest or progression

研究概览

简要总结

Dental caries a widespread global disease having a very high prevalence and it requires treatment to stop its progression. Children in developing countries are highly vulnerable and have high rates of untreated caries. Due to the extensive equipment required for its treatment it limits its reach to people and requires on site intervention. The abstract provides a concise overview of comparing the efficacy of four different caries arresting agents that will be compared by means of a community based, randomized clinical trial in primary teeth.  A total of 240 children with an active carious lesion would be selected and randomly divided into one of the four groups-silver diamine fluoride varnish, Nano silver fluoride, sodium fluoride varnish and a solution of silver fluoride in water with Potassium iodide. The child and parental satisfaction level would be assessed by means of self-reports at 6 months. After the application of the caries arresting agent according to given guidelines follow up will be done at 3,6 and 12 months to check if the carious lesion is active. Through a comprehensive analysis this study aims to find which carries arresting agent demonstrates the most superior efficacy to arrest a carious lesion in a community setting.

Keywords-Caries arrest, SDF, Primary teeth, caries arresting agents, community based, randomized control trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Cooperative healthy child Children- age of 4 to 9 years with an active carious lesion.
  • Children studying in a school in Faridabad.
  • Absence of pain, pulp involvement, tooth mobility.
  • Children who assent to the procedure and have obtained a written informed consent from their parents/guardians.

排除标准

  • Criteria for exclusion: Children whose parents have refused to give a written informed consent to be a part of the study.
  • Carious tooth close to exfoliation within 18 months Even if there is a slight mobility noticed in the tooth it will not be included in the study.
  • Children with a known allergy to silver or other heavy metal ions Children with special needs or limited dexterity of hands.

结局指标

主要结局

Caries arrest or progression

时间窗: 3,6 months

次要结局

  • Re-initiation of carious lesion(12 months)

研究者

发起方
Manav Rachna Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sharmistha Dewakar Goel

Manav Rachna Dental college

研究点 (1)

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