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临床试验/CTRI/2018/01/011175
CTRI/2018/01/011175已完成3 期

Comparative evaluation of Antimicrobial and Anti-gingivitis effect of Ocimum sanctum Linn. gel with 0.2% Chlorhexidine gel- A double blind placebo controlled randomized trial

Dr Anupa Jankish1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月2日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The antimicrobial and anti-gingivitis effect of tulsi leaf extracr based gel will be evaluated by assesssing the plaque samples and improvement in the clinical parameters

研究概览

简要总结

study hypothesis : to test the efficacy of a herbal based (tulsi leaf extract) gel in addition to standard oral hygiene practice in patients with moderate to severe gingivitis

A total of 60 systemically healthy patients diagnosed with chronic generalised gum infection will be included. Complete oral examination along with clinical parameters and plaque samples will be taken, after which all patients will undergo thorough oral prophylaxis (cleaning of teeth). After this they will be randomly allocated into any of the three groups. of which one group will receive the experimental tulsi gel (test group), second group will get chlorhexidine gel (control group) and the third group will get a placebo gel (placebo group). instructions on usage of the gel and oral hygiene instructions will be given to the patient. the patient will be recalled for follow up at 15 days and 3 months. during the initial and follow up visits complete oral examination will be done along with collection of plaque samples for clinical and microbiological analysis.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator 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

  • 1.presence of a minimum of 24 functional teeth 2.patients with moderate to severe form of gingivitis 3.patients withtin the age group of 18-45 years.

排除标准

  • 1.Subjects with removable or fixed orthodontic appliances or prosthesis.
  • 2.Subjects who have been prescribed antibiotics or anti-inflammatory drugs in the past 3-6 months 3.Patients with any systemic involvement 4.Subjects with any reported allergy 5.Subjects with any tobacco related habits
  • Pregnant and lactating women.

结局指标

主要结局

The antimicrobial and anti-gingivitis effect of tulsi leaf extracr based gel will be evaluated by assesssing the plaque samples and improvement in the clinical parameters

时间窗: recall intervals of 15 days and 3 months

次要结局

  • plaque index(gingival index)

研究者

发起方
Dr Anupa Jankish
申办方类型
Other [self-funded]

研究点 (1)

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