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临床试验/CTRI/2024/05/066722
CTRI/2024/05/066722已完成不适用

Comparison Of Conventional Soft bristled and Nano bristled toothbrushes on Oral Hygiene status, Toothbrush wear and Patient reported outcome measures – A Randomized Clinical Trial

Dr Thota Saranya1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月31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
90
试验地点
1
主要终点
Assessment of Oral Hygiene Index Simplified (OHI-S),Plaque Index and Gingival Index

研究概览

简要总结

The present study compares Oral Hygiene status, Toothbrush wear and Patient reported outcome measures of conventional soft bristled and Nano bristled toothbrushes. Students and individuals following inclusion criteria will be selected for this study. Randomization will be done and individuals will be divided into three group. For One group, Conventional soft bristled toothbrushes will be given. For Second group, Nano silicone bristled toothbrushes will be given. For third group, Nano charcoal bristled toothbrushes will be given. Individuals will be instructed to brush their teeth twice daily for 2 min using the toothbrush and Colgate dentifrice given for the study purpose in modified bass technique and not to use any other interdental aids and undergo any oral hygiene procedures.Oral Hygiene Index-Simplified, Plaque Index, Gingival Index will be assessed at baseline, 1 month, 2 months and 3 months. Toothbrush wear will be assessed at 1 month and 3 months. Patient reported outcome measures will be assessed at 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Age range of 18-45years 2)Non- smokers 3)Controlled systemic conditions 4)Good oral health 5)Six teeth excluding third molar in each quadrant with no crowns, orthodontic appliances 6)No periodontal pocket ≥3 mm or attachment loss ≥2 mm.

排除标准

  • Patients with uncontrolled systemic diseases 2)Pregnancy or lactating women 3)Chronic smokers 4)Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C) 5)Patients with any known allergies to new materials 6)Patients with mucogingival problems 7)Patients with fixed or removable prosthesis.

结局指标

主要结局

Assessment of Oral Hygiene Index Simplified (OHI-S),Plaque Index and Gingival Index

时间窗: Assessment of Oral Hygiene Index-OHI-Simplified (OHI-S), Plaque Index and Gingival Index will be assessed at baseline, 1 month, 2 months and 3 months

次要结局

  • 1)To assess Toothbrush wear(2) Patient reported outcome measures)

研究者

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

Dr Thota Saranya

Vishnu Dental College

研究点 (1)

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