Effect of Dant Kanti Gum Paint on Gingival Bleeding: Prospective, Open-Label, Single-Arm, Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in the Gingival score Plaque scores Papillary Bleeding Index and Microbial Assessment
研究概览
简要总结
This single arm, open label, observational, prospective study will evaluate the effect of Dant Kanti Gum Paint in gingival bleeding. Subjects will be screened based on Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The eligible subjects will be assigned to use Dant Kanti Gum Paint for the next 14 days from the day of enrolment and Gingival score, Plaque scores, papillary bleeding index, microbial assessment will be evaluated to check the efficacy. Oral Health 15 questionnaire will be used to check Oral Health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Good general health Subjects having gingival index more than 1 At baseline all the subjects had to have a plaque index greater than 2.
排除标准
- •Patients with systemic diseases or compromising medical conditions Patient who made frequent use of painkillers, antiinflammatory and antidepressant drugs Any condition the investigator identifies that can confound the participants ability to properly participate in the study Patients who have used mouth rinse containing chemical agents in the previous 2 months The subjects not willing to provide consent Habit of betel quid chewing.
结局指标
主要结局
Change in the Gingival score Plaque scores Papillary Bleeding Index and Microbial Assessment
时间窗: From Day 1 to Day 07 and from Day 01 to Day 14
次要结局
- Changes in the Oral Health 15 questionnaire(From Day 1 to Day 07 and from Day 01 to Day 14)
研究者
Dr Kuldeep Singh
Patanjali Ayurved Hospital Patanjali Yogpeeth Phase 1