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临床试验/NCT07125937
NCT07125937已完成不适用

ROLE OF SILVER DIAMINE FLUORIDE (SDF) IN ARRESTING ENAMEL CARIES IN ADULTS REPORTING TO DENTAL COLLEGE HITEC-IMS TAXILA

HITEC-Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年5月7日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Proportion of enamel caries lesions arrested after SDF application

研究概览

简要总结

This interventional study aims to evaluate the effectiveness of 38% Silver Diamine Fluoride (SDF) in arresting enamel caries in adults aged 18-50 years. Dental caries is a biofilm-mediated, multifactorial disease that can cause progressive tooth damage. Conventional treatments are invasive and costly, whereas SDF offers a non-invasive, low-cost alternative. A total of 250 patients meeting the inclusion criteria will be treated with SDF following the UCSF protocol. Lesions will be evaluated clinically using ICDAS and radiographically using ICCMS at 3 weeks and 3 months post-intervention. The primary outcome is the proportion of enamel caries lesions arrested after treatment. Data will be analyzed using the chi-square test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group of subjects between 18 - 50 years
  • Carious lesions with ICDAS score 1, 2 and 3 in molars and premolars

排除标准

  • PDL widening with periapical radiolucency around molars and premolars
  • Premolars and Molars with any white lesions other than caries
  • Third molars

研究组 & 干预措施

38% Silver Diamine Fluoride Application

Experimental

Participants will receive a single application of 38% Silver Diamine Fluoride (Advantage Arrest™, Elevate Oral Care LLC) on enamel caries lesions (ICDAS scores 1-3) in molars and premolars, following the UCSF protocol. Lesions will be evaluated clinically (ICDAS) and radiographically (ICCMS) at 3 weeks and 3 months post-treatment to assess caries arrest.

干预措施: 38% Silver Diamine Fluoride (Drug)

结局指标

主要结局

Proportion of enamel caries lesions arrested after SDF application

时间窗: 3 months post-intervention

Lesions will be clinically evaluated using the International Caries Detection and Assessment System (ICDAS) and radiographically using the International Caries Classification and Management System (ICCMS). Arrest is defined as no progression in ICDAS score and no radiographic progression

次要结局

未报告次要终点

研究者

发起方
HITEC-Institute of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Kinza Iftikhar

Kinza Iftikhar

HITEC-Institute of Medical Sciences

研究点 (1)

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