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临床试验/CTRI/2024/05/067869
CTRI/2024/05/067869尚未招募不适用

Comparative evaluation of efficacy of antimicrobial mouthwash and probiotic mouthwash on streptococcus mutans levels in saliva and gingival health of patients undergoing fixed orthodontic treatment. A Randomized Clinical Trial.

Dr Gopal Cheke1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年6月5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
54
试验地点
1
主要终点
To check if the intervention that is probiotic mouthwash has a beneficial effect for reducing bacterial levels in saliva in the patients undergoing orthodontic treatment.

研究概览

简要总结

A randomized clinical trial will be conducted on 54 patients undergoing fixed orthodontic treatment. Patients are divided into 3 groups having 18 patients in each group. The groups will be as follows:

Group 1- Antimicrobial mouthwash group.

Patients in this group will be given 0.2% antimicrobial mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the

mouthwash. Instructions to maintain proper oral hygiene will be given.

Group 2- Probiotic mouthwash.

Patients in this group will be given probiotic mouthwash. They will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.

Group 3- Control group

Patients in this group are used as control group. They will be advised to brush twice daily with toothpaste and instructions to maintain proper oral hygiene will be given.

 The saliva samples of the patients will be collected in the sterile containers. The samples will be collected at two intervals that is at 1st day and 30th day. The collected samples will be store in deep freezer at -20 degree Celsius. The collected saliva samples will be then transported to the laboratory for PCR analysis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 28.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing orthodontic treatment with preadjusted edgewise appliance (MBT).
  • Overall good general health.
  • Permanent dentition.
  • No anti-inflammatory or antibiotics and mouthwash used in last week.

排除标准

  • Patient with facial deformities.
  • Patient with severe periodontal problems.
  • History of parafunctional habits.
  • History of maxillofacial surgery or jaw injuries.

结局指标

主要结局

To check if the intervention that is probiotic mouthwash has a beneficial effect for reducing bacterial levels in saliva in the patients undergoing orthodontic treatment.

时间窗: 1 day, 30 days.

次要结局

  • To check if the control group shows similar effects as that of the intervention group or less than that.(1 day, 30 days.)

研究者

发起方
Dr Gopal Cheke
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Gopal Cheke

Saraswati dhanwantari dental college, pathari road parbhani.

研究点 (1)

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