Clinical trial to evaluate the antimicrobial and antifungal efficacy of five oral hygiene products in healthy adult volunteers
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reduction in germ count in percentage in comparison to baseline and control product.
研究概览
简要总结
Dental hygiene refers to the practice of keeping the mouth, teeth and gums clean and healthy to prevent disease. Dental hygiene and oral health are often taken for granted but are essential parts of our everyday lives. The antimicrobial properties of ayurvedic ingredients present in toothpastes and mouthwashes help in maintaining oral hygiene. This study is to evaluate the antimicrobial efficacy of the different oral hygiene products in by assessing the total viable count and specifically s.mutans and candida albicans (two groups) as markers and beneficial effect in maintaining oral hygiene.
The study includes Red Paste, Red BAE gel, Pulling Oil and Dant Rakshak toothpastes along with a marketed comparator product. The microbiological study will be performed on clinical isolates obtained by oral swabs at variou stime points on the same day, i.e, Before brushing, immediately after brushing, 2 hrs after brushing and 4 hrs after brushing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate Subjects of both genders in age group 18 – 65 years (both the ages inclusive).
- •Subjects willing to give their swab samples for analysis.
- •Subjects willing to follow 12 hr overnight gap of brushing/mouthwash and 4 hr fasting after brushing/mouthwash.
- •Subjects willing to come for follow up visits at the specified time.
- •Subjects ready to follow instructions during the study period .
- •Subjects using toothpastes and mouthwash other than Dabur.
排除标准
- •â€¢A known history or present condition of hyper sensitivity to any toothpaste.
- •â€¢The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
- •â€¢Any history of periodontal therapy by surgical interventions.
- •â€¢Any history of dentine hypersensitivity treatment.
- •â€¢Orthodontic treatment with ï¬xed appliances.
- •â€¢Any removable device such as a removable partial denture or orthodontic retainer.
- •â€¢The presence of any ï¬xed appliance, large or defective restorations, cracked enamel, •History of smoking or smokeless tobacco products.
- •â€¢Subjects having moderate to severe dentine hypersensitivity.
- •â€¢Subjects who are pregnant, lactating or nursing.
- •â€¢Subjects having severe level of calculus and/ tartar.
- •â€¢Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
结局指标
主要结局
Reduction in germ count in percentage in comparison to baseline and control product.
时间窗: Before Brushing, After brushing (Immediately, 2hr and 4 hr)
次要结局
- Reduction in specific germ counts in selected groups as compared to baseline and control product.(Before Brushing, After brushing (Immediately, 2hr and 4 hr))