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临床试验/CTRI/2020/10/028629
CTRI/2020/10/028629已完成不适用

Efficacy of short headed toothbrush: A clinical study

Curaden1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月30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
20
试验地点
1
主要终点
Plaque index and Gingival index

研究概览

简要总结

This was a cross-over study, done to compare plaque removal capacity of 2 types of toothbrushes. A group 20 subject fulfilling the inclusion criteria and willing to participate was selected. They were divided into 2 groups of 10 participants each and were instructed to refrain from brushing for 24 hours and report to the Department of Periodontology.

At baseline, the plaque index (PI) and gingival index (GI) was recorded. The subjects in group A was provided with regular standard toothbrush and subjects of group B was provided with the small headed toothbrush. No brushing instructions were given. They were advised to use the toothbrush for 1 week.

After 1 week, again the clinical parameters was recorded. Then a washout period of 2 weeks was given. After the washout period, again the same group of participants were asked to refrain from brushing for 24 hours. The clinical parameters were assessed using the PI and GI.  The subjects of group A were provided with the small headed toothbrush (CURADEN) and those of group B were provided with standard toothbrush. They were advised to use it for 1 week without any brushing instruments. After 1 week again all the clinical parameters were recorded. A questionnaire was also provided to record the patient’s preference and experience.

The indices were recorded using mouth mirror and the Williams graduated periodontal probe.

研究设计

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

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients with a full set of natural teeth excluding the third molars Age up to 40 years Patients who have GI score ≥ 1.5 and probing depth ≤ 5mm.

排除标准

  • Medically compromised Smoking Patients who have undergone periodontal treatment in the last 6 months.
  • Patients who have taken antibiotics in the last 6 months.

结局指标

主要结局

Plaque index and Gingival index

时间窗: One week

次要结局

  • Plaque index, Gingival index and patient satisfaction(One month)

研究者

发起方
Curaden
申办方类型
Other [Swiss-owned company]

研究点 (1)

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