A randomized, multi - centric single blinded three arm parallel group comparative clinical trial to assess the efficacy and safety of GuruNanda natural oil pulling oral rinse in maintaining and improving oral hygiene and periodontal health
概览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Plaque Index (PI) and Modified Gingival Index (MGI) from
概览
简要总结
60 adults requiring oral hygiene support for maintaining or to improve peridontal health will be enrolled in the study. All the study subjects will receive a set of toothbrush and toothpastes from same manufacturer to overcome the confounding bias.
The study subjects will be asked to self-administer the test product 10 ml into their mouth for 2 minutes and will be asked to split out the content and rinse with normal water once daily in the morning for test & placebo, 10 ml daily in the morning followed by brushing for 8 weeks
Group 1 -Gurunanda Natural Oil Pulling Oral Rinse
Group 2- Colgate Perigold Mouthwash
Group 3- Placebo
Primary Outcomes- 1) To assess the effect of test product on OHI, PI and MGI from baseline and end of the study 2) To assess % mean reduction in cariogenic oral microflora from baseline to end of the study 3) To assess % mean reduction CFU in gram positive bacteria 4) To assess % mean reduction CFU in gram negative bacteria 5) To assess % mean reduction CFU in fungus 6) Effect of test in reducing Cavities 7) Effect of test Product in reducing Halitosis 8) Effect of test Product in reducing bleeding gums
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
- •Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving periodontal health and who agree to comply with the study procedures.
- •Subjects having gingival probing depth of less than 3mm.
- •3.Subjects having gingival index scores of equal to 2 and in more than 10 percent of the sites 4.Subjects with no history of hypersensitivity reactions.
- •5.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 7.Subjects having plaque index scores of equal to 2 and in more than 10percent of the sites.
排除标准
- •1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures;
- •Subjects with chronic or aggressive periodontitis;
- •Subjects with history of oral antibiotic prophylaxis within the past 1 month; 4.Tobacco consumers and smokers, 5.Subjects who are on any antibiotic therapy for the past 1 month and subjects with any other medical history that could compromise the conduct of the study 6.Subjects who are pregnant or lactating.
- •7.Subjects with previous history of any allergic reactions to the test products 8.
结局指标
主要结局
1.Plaque Index (PI) and Modified Gingival Index (MGI) from
时间窗: Baseline, week 4 and week 8
baseline to end of study
时间窗: Baseline, week 4 and week 8
2. To assess percentage mean reduction CFUs in cariogenic oral microflora (S.mutans) from baseline to end of study.
时间窗: Baseline, week 4 and week 8
3. To assess percentage mean reduction CFUs of gram positive from baseline to end of study
时间窗: Baseline, week 4 and week 8
4.To assess percentage mean reduction CFUs in fungus from baseline to end of study.
时间窗: Baseline, week 4 and week 8
5.Effect of test product in reducing the Cavities
时间窗: Baseline, week 4 and week 8
6.Effect of test product in reducing Halitosis
时间窗: Baseline, week 4 and week 8
7.Effect of test product in reducing bleeding gums
时间窗: Baseline, week 4 and week 8
8.To assess percentage mean reduction CFUs in below gram negative from baseline to end of study.
时间窗: Baseline, week 4 and week 8
次要结局
- 1.To assess improvement in Clinical Oral Dryness Score (CODS)(from baseline to end of study.)
研究者
Dr B Ramkumar
Ram’s Dental Hospital