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临床试验/CTRI/2025/08/093441
CTRI/2025/08/093441尚未招募不适用

Effectiveness of Sodium Fluoride varnish in adjunction with Chlorhexidine or Povidone iodine versus Sodium Fluoride varnish alone for caries prevention in 12-year olds: A Randomized Controlled Trial

Dr Abhishek1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年9月30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
360
试验地点
1
主要终点
(I) Net caries increment assessed by subtracting the number of

研究概览

简要总结

Dental caries is most common chronic non- communicable disease affecting 3.5 billion people worldwide. Many strategies have been practiced to check the progression of dental caries out of which fluoride use is most common. A  newer strategy involving use of an antibacterial agent along with fluoride agent. Chlorhexidine and povidone iodine are common antibacterial agents used in dentistry. This clinical trial aims to compare the efficiency of fluoride varnish in adjunction with chlorhexidine or povidone iodine in comparison with sodium fluoride varnish alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
11.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Persons willing to participate.
  • Participants living in the same area since birth.
  • At least 16 teeth are present.
  • Coronal caries with ICDAS score equal to or less than 3.

排除标准

  • (I) Participants with systemic disorders.
  • (II) Participants not giving consent.
  • (III) Uncooperative participants.
  • (IV) Hypoplastic teeth.
  • (V) Patients with severe gingivitis, or other conditions where maintenance of oral hygiene is not possible.
  • (VI) Participants undergoing orthodontic treatment.
  • (VII) Participants taking any active treatment.
  • (VIII) Participants who took antibiotic drugs in the last 1 month.
  • (IX) Participants involved in any other trial.

结局指标

主要结局

(I) Net caries increment assessed by subtracting the number of

时间窗: (ii) S. mutans Bacterial colony | count

reversed or remineralized lesions from the total number of new lesions recorded at follow- up. Active lesions will only be considered

时间窗: (ii) S. mutans Bacterial colony | count

次要结局

  • (ii)Streptococcus Mutans colony count at first & second follow up(At 6 & 12 months after baseline)

研究者

发起方
Dr Abhishek
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Abhishek

Post Graduate Institute of Dental Sciences,Rohtak

研究点 (1)

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