跳至主要内容
临床试验/CTRI/2019/05/019336
CTRI/2019/05/019336尚未招募2 期

Efficacy of White Tea and Green Tea mouthrinse compared to chlorhexidine mouthrinse against dental plaque, gingivitis and Salivary Streptococcus mutans: A Randomized Controlled Trial

Sudha Rustagi College of Dental Sciences and Research1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年1月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
1.Loe & Silness Gingival Index

研究概览

简要总结

Background: Health benefits of green tea can be attributed to catechins, bio active compounds i.e. polyphenols regarding antioxidant,anti-cancer , anti-inflammatory, anti-bacterial, anti-mutagenic properties. To our knowledge, very few studies on the beneficial effect of white teaon oral health are found in literature.

Aim: To test the efficacy of white tea and green tea  in reducing the plaque index (PI) scores,gingival index (GI) and  Salivary Streptococcus mutans colony count.

Methodology: A parallel design randomized controlled trial will be conducted among 66 subjects aged 18-35 years. Participants will be randomized into White Tea, Green Tea and CHX group using lottery method. Subjects will be instructed to use 10 ml of provided mouthwashfor 30 secondstwice daily for 3 weeks. Plaque score, gingival score and Salivary S. mutans colony counts will be recorded at baseline and post-intervention (3 weeks).

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Minimum 20 sound, natural teeth (non-carious)
  • Subjects willing to give an informed consent and follow the schedule.
  • Subjects with good general health.

排除标准

  • Subjects with grossly decayed teeth, full crown or extensively restored teeth or undergoing orthodontic treatment.
  • Subjects with any intraoral soft tissue pathology.
  • Subjects undergoing antibiotic treatment or had it in last one month
  • Subjects using antimicrobial mouthrinses.
  • Subjects consuming a high polyphenol diet (including green tea or soya diet),
  • Subjects wearing appliances, or prostheses (fixed or removable)
  • Subjects with smoking habit.
  • Subjects having history of periodontal treatment within last 3 months.

结局指标

主要结局

1.Loe & Silness Gingival Index

时间窗: At baseline and at 21 day

2.Turesky-Gilmore modification of Quigley Hein Plaque Index

时间窗: At baseline and at 21 day

3.Salivary Streptococcus mutans (S. mutans) colony count

时间窗: At baseline and at 21 day

次要结局

  • 1) Staining of teeth – Measured using modified Lobene stain index(2) Taste alteration – Self reported)

研究者

发起方
Sudha Rustagi College of Dental Sciences and Research
申办方类型
Other [Private Dental College]

研究点 (1)

Loading locations...

相似试验

Antimicrobial efficacy of White Tea and Green Tea... | 临床试验