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临床试验/CTRI/2022/11/047230
CTRI/2022/11/047230进行中(未招募)不适用

Comparative evaluation of antibacterial efficacy, Clinical effects and Patient perception on usage of Cetyl pyridinium chloride based products with regular mouthwash and dentifrice in Orthodontic patients- A Randomized control study

Bhogi Akhil Kumar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月16日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
1. anti bacterial efficacy of mouthwash and dentifrice,

研究概览

简要总结

The aim of the academic research study is to compare and assess anti-bacterial efficacy, clinical effects and patient perception using CPC based products with regular mouth wash and dentifrice. 48 Patients who meets inclusion criteria will be included in the study. After the oral prophylaxis, brackets placement followed by arch wire in the baseline will be done. Proper brushing technique is explained to the patients. Based on lottery method patients will be randomly divided into experimental and control groups. Patient will be recalled after 15days. Patients will be prescribed with specific mouthwash/dentifrice and are advised to use them for 1month. Frequency, duration, techniques for use are explained. Clinical parameters such as gingival index and plaque index will be noted for clinical evaluation, Plaque sample will be collected for bacterial evaluation. Patient will be recalled on 30thday and 45th day where gingival index, plaque index will be recorded, plaque sample will be taken for bacterial count, a questionnaire form will be given to the patient to evaluate his perception on usage of these products.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • 1.Age range of 18-25 years.
  • 2.Willingness to participate in the study 3.Mild gingivitis 4.Patients with Pre adjusted edgewise stainless steel brackets.

排除标准

  • Antibiotic therapy in last month .
  • Medical problems .
  • Pregnancy and lactation .
  • Moderate or severe gingivitis/ periodontitis .
  • Using any mouth rinse in last month.

结局指标

主要结局

1. anti bacterial efficacy of mouthwash and dentifrice,

时间窗: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday

2. Periodontal index

时间窗: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday

3. Gingival index

时间窗: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday

次要结局

  • patients perception by a questionnaire(T1-30th day, T2-45th day)

研究者

发起方
Bhogi Akhil Kumar
申办方类型
Other [self]

研究点 (1)

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