CTRI/2021/07/034750已完成2 期
Clinical study to evaluate the efficacy and safety of an oral care product on oral malodour reduction and its causative microflora in healthy adult subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Ã¢â?¬Â¢Having at least 16 natural, permanent teeth.
- •Ã¢â?¬Â¢Subjects with bad oral hygiene and halitosis (self-reported or clinically diagnose). Subjects who have plague and dental caries.
- •Ã¢â?¬Â¢Subjects willing to give their swab samples for analysis.
- •Ã¢â?¬Â¢Subjects willing to follow 12 hr. overnight gap of brushing/mouthwash and 4 hr. fasting after brushing on day 30 assessment.
- •Ã¢â?¬Â¢Subjects willing to come for follow up visits at the specified time.
- •Ã¢â?¬Â¢Subjects ready to follow instructions during the study period.
- •Ã¢â?¬Â¢Subjects who use oral hygiene products other than Dabur.
- •Ã¢â?¬Â¢Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
排除标准
- •Ã¢â?¬Â¢A known history or present condition of hyper sensitivity to any toothpaste.
- •Ã¢â?¬Â¢The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
- •Ã¢â?¬Â¢Any history of periodontal therapy by surgical interventions.
- •Ã¢â?¬Â¢Any history of dentine hypersensitivity treatment. Subjects having moderate to severe dentine hypersensitivity.
- •Ã¢â?¬Â¢Orthodontic treatment with ï¬?xed appliances.
- •Ã¢â?¬Â¢Any removable device such as a removable partial denture or orthodontic retainer.
- •Ã¢â?¬Â¢The presence of any ï¬?xed appliance, large or defective restorations, cracked enamel,
- •Ã¢â?¬Â¢History of smoking or use of smokeless tobacco products.
- •Ã¢â?¬Â¢Subjects having moderate to severe dentine hypersensitivity.
- •Ã¢â?¬Â¢Subjects having abnormal frenum attachment.
- •Ã¢â?¬Â¢Subjects who are pregnant, lactating or nursing.
- •Ã¢â?¬Â¢Subjects having severe level of calculus and/ tartar.
- •Ã¢â?¬Â¢Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
研究者
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