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临床试验/CTRI/2024/11/076113
CTRI/2024/11/076113尚未招募不适用

Evaluating Diagnostic Accuracy of Fluorescent Starch Nanoparticles Oral Rinse in Detection of Early Carious Lesion in Children aged 7 to 11 years – A Cross-Sectional Study

Dr. Vashi Mitulkumar Narendra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To Evaluate Diagnostic Accuracy of Oral Rinse containing Targeted Fluorescent Starch Nanoparticles in Detection of Early Carious Lesion in children aged 7 to 11 years.

研究概览

简要总结

LumiCareâ„¢ Caries Detection Rinse (GreenMark Biomedical Inc, USA) provides quick and painless, preventive dental care for children. It is a water-based solution containing patented fluorescent sub-micron starch particles that have been functionalized to target and adhere to the subsurface of early-stage carious lesions after penetrating through surface porosities. [14]

Implementing early caries detecting oral rinse at the community level is crucial for promoting oral health and preventing dental decay. This proactive approach allows for timely identification of initial tooth decay stages, enabling prompt intervention and treatment. By incorporating such rinses into community oral health initiatives, individuals can detect issues early, leading to more effective management and potentially preventing progression to severe stages. Our ultimate goal is to develop a new clinically valid methodology to diagnose early carious lesions that also enables effective monitoring of conservative treatment.

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Children with age group of 7-11 years showing Frankl Behaviour Rating Scale of 3 and
  • Children with minimum ICDAS II score of 1 or
  • Children who are able to rinse properly.

排除标准

  • 1.Children having hypoplasia, fractures, dentinogenesis imperfecta, amelogenesis imperfecta and other conditions affecting the structural health of the enamel.
  • 2.Children having intrinsic and extrinsic stains.
  • 3.Children who do not give assent and parents who do not give written consent for their child to participate in the study.
  • 4.Children with special health care needs.

结局指标

主要结局

To Evaluate Diagnostic Accuracy of Oral Rinse containing Targeted Fluorescent Starch Nanoparticles in Detection of Early Carious Lesion in children aged 7 to 11 years.

时间窗: Baseline

次要结局

  • To develop a new clinically valid methodology to diagnose early carious lesions that also enables effective monitoring of conservative treatment.(Baseline)

研究者

发起方
Dr. Vashi Mitulkumar Narendra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vashi Mitulkumar Narendra

K. M. Shah Dental College and Hospital

研究点 (1)

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