CTRI/2020/07/026522已完成1 期
An Open Label, Single Arm, Clinical Study to Evaluate Efficacy and Safety of MNDV toothpaste in Dental Care of Healthy Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effect of test product for reduction in gingivitis (inflammation of gums) & to evaluate gum tightening by dental examination using modified gingival index.
研究概览
简要总结
Consideration of oral hygiene and the importance of Ayurveda for dental care is time tested. This research is an attempt to evaluate safety and efficacy of dental paste developed by MN pharmaceuticals in dental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy male or non-pregnant/non-lactating females.
- •Females of Childbearing potential must have a negative urine pregnancy test performed on screening and enrollment visit.
- •Subjects are in good general health as determined by the Investigator on the basis of medical history.
- •Subjects having T-VSC reading (total volatile sulphur compounds) of >160 ppb (parts per billion) Subjects with mild, moderate and severe plaque with plaque index 2-
- •Subjects with mild to moderate gingivitis with modified gingival index 0.1-0.
- •Subjects should be willing to come to the test site without brushing their teeth in the morning.
- •Subjects should be willing to not to consume anything except water after meal of previous night.
- •Subjects must be able to understand and provide written informed consent to participate in the study.
- •Subjects should be willing and able to follow the study directions to participate in the study.
排除标准
- •Subjects with orthodontic bands.
- •Subjects with plaque index of 0, 1 and 5 Subjects with partial removable dentures.
- •Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
- •Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) Subjects having carious lesion which requires immediate restorative treatment.
- •Subjects having used antibiotics anytime during the last three months prior to entry into the study.
- •Subjects having participated in any other dental clinical study within last six months prior to entry into the study.
- •Subjects with dental prophylaxis during the past two weeks prior to baseline examinations.
- •Subjects with history of allergies to any oral care/personal care consumer products or their ingredients.
- •Subjects on any prescription medicines that might interfere with the study outcome.
- •Subjects taking oral contraceptives and other medication based contraceptives.
- •Pregnant female subjects or female planning to get pregnant during study duration.
- •Subjects with diseases or having history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.) Subjects that consume alcohol.
- •Subjects that smoke cigarette or consume any other form of tobacco.
结局指标
主要结局
To evaluate the effect of test product for reduction in gingivitis (inflammation of gums) & to evaluate gum tightening by dental examination using modified gingival index.
时间窗: From baseline to end of study ie day 30.
次要结局
- To evaluate the effect of test product on malodor control using Halimeter.(To evaluate the effect of test product for plaque reduction using plaque index)
研究者
研究点 (1)
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