A single blind, single centric, randomized 3 arm parallel study to demonstrate the efficacy and tolerability of Gurunanda Natural Oil Pulling Oral Rinse in the management of Gum Health and Gingivitis when compared to Chlorhexidine and Placebo.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1. Reduction of Modified gingival Index.
研究概览
简要总结
Randomized, single blind, 3 arm and placebo controlled study to assess the effectiveness and safety of active when compared to comparator and placebo. This is a single centre study. This study is planned to be conducted in a clinical site the EC of the institution is registered with CDSCO. Study will start only after receiving the CTRI registration number.
The study population is patients diagnosed with Gingivitis. Only after all the inclusion exclusion criteria is met the subjects will be recruited into the study. Subject population is 66.
66 subjects will be divided into 3 groups each having 22 subjects in a group - active, comparator and placebo. The duration of the study will be for 56 day.
The study outcome will be improvement of gingival and plaque index. Reduction of carcinigenic oral microflora. Significant reduction in CFUs in gram positive and negative microbes. Improvement of oral dryness scoring score and teeth shade. Enhancement of organoleptic score. There will be 4 visits - screening, baseline, week 4 and week 8.
Study design: Randomized, single blind, 3 arm and placebo controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female subjects (age 18-60yrs) 2.Subjects with at least 24 teeth.
- •3.Subjects having gingival probing depth of less than 3mm.
- •4.Subjects having gingival index scores equal to 2 and in more than 10% of the sites.
- •5.Subjects having plaque index scores equals to 2 and in more than 10% of the sites.
- •6.Subjects with no history of hypersensitivity reactions.
- •Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- •Subjects should not have history of periodontal therapy one month prior to screening.
- •Patient should be able to give written informed consent prior to participating in the study.
排除标准
- •Subjects who have used antibiotics, antimicrobials, steroidal anti- inflammatory drugs, desensitizing toothpaste and NSAIDs within one month prior to screening.
- •Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, psychiatric diseases, blood disorders, gastrointestinal diseases).
- •Subjects with systemic conditions like diabetes, gastritis; oral diseases such as advanced periodontitis, frank dental caries, mucosal lesions.
- •Subjects with history of smoking or chewing tobacco.
- •Subjects with orthodontic appliances.
- •Hypersensitivity to any components of the investigational product.
- •Pregnancy and breastfeeding women.
- •Participation in concomitant interventional clinical study during the previous 30 days.
结局指标
主要结局
1. Reduction of Modified gingival Index.
时间窗: screening week 4, 8
2. Reduction of Plaque Index.
时间窗: screening week 4, 8
次要结局
- 1.Reduction of cariogenic oral microflora.(2.In achieveing a significant reduction in CFUs in gram positive.)
研究者
Dr Ashwin Prabhu
Rajalakshmi Hospital and Research Center.