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临床试验/CTRI/2022/11/047246
CTRI/2022/11/047246已完成不适用

Effectiveness of New Activated Charcoal Orthodontic Toothbrush On Plaque Removal in Orthodontic Patients Using Orthodontic Plaque Index And Gingival Index: A Randomized Cross-Over Study.

Dr Prakher saini1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The objective of this study is to evaluate the effectiveness of a new activated charcoal orthodontic toothbrush designed with a conventional orthodontic toothbrush and conventional charcoal infused toothbrushes on better plaque control in patients undergoing fixed orthodontic treatment when compared to Conventional v cut orthodontic toothbrush.

研究概览

简要总结

§  Recently, toothbrushes with charcoal-infused nylon bristles have been introduced. Charcoal, as a chemical, is a good absorbent neutralizer for toxins, poisons, and noxious gases and hence reduces bacterial contamination. A study conducted in 2017 by Lee et al. found that aerobic microbial contamination of charcoal toothbrushes was half when compared to non-charcoal-infused toothbrushes. Also, charcoal-infused bristles demonstrated minor wear and more plaque removal than conventional nylon bristles. Therefore, introducing charcoal-infused bristles with orthodontic toothbrushes may improve oral hygiene maintenance with lesser effort. Hence, to evaluate the efficacy of charcoal-infused bristles in orthodontic patients, which may be a better alternative for providing good oral hygiene, especially for orthodontic patients, this study is undertaken.

§  This study may prove to be of assistance and patient acceptance towards having good oral hygiene, with more predictable outcomes in Orthodontic treatment.

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Open Label

入排标准

年龄范围
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patient with fair oral hygiene index Age between 15 and 30 years No history of antibiotics, steroids, or NSAIDs in the past two months Each subject must have plaque index score <1 (orthodontic modified Sillness and loe).

排除标准

  • Presence of any local or systemic disease or immunosuppressant drug therapy.
  • Use of antibiotics, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) therapy within the past two months or during the study Mentally handicapped subjects Subjects with poor manual dexterity Poor compliance subjects Using antibacterial mouth rinses Patients with a history of allergies to food dyes (especially contents of DPI- AlphaPlac, study toothpaste) Pregnancy Previous or current use of powered or manual orthodontic toothbrushes Subject using Smoking, tobacco products.

结局指标

主要结局

The objective of this study is to evaluate the effectiveness of a new activated charcoal orthodontic toothbrush designed with a conventional orthodontic toothbrush and conventional charcoal infused toothbrushes on better plaque control in patients undergoing fixed orthodontic treatment when compared to Conventional v cut orthodontic toothbrush.

时间窗: 21th week

次要结局

  • Value of orthodontic plaque index before and after toothbrushing.(baseline, 2nd week, 4th week, 6th week)

研究者

发起方
Dr Prakher saini
申办方类型
Other [self]

研究点 (1)

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