CTRI/2014/04/004519已完成2 期
Effect of Test Chewing Gums on Oral Malodour and Oral Pathogens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ITC Limited
- 入组人数
- 78
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
- •1. Males and females, more than or equal to 18 years to less than or equal to 50 years of age
- •2. Halimeter reading of T-VSC (total volatile sulphur compounds) of 200 ppb (parts per billion) or more
- •3. Salivary levels of S. mutans more than 10,000 CFU/mL
- •4. Subjects with non-compromised oral health â?? Subjects should not have untreated caries lesions, clinical signs of gingivitis or periodontal disease, orthodontic patients, oral carcinoma, etc.
- •5. Subjects not undergoing antibiotic or antimicrobial therapy
- •6. Subjects willing to use standard toothpaste and toothbrush provided to them, throughout the study
- •7. Subjects willing to use a tongue cleaner provided to them, throughout the study
- •8. Females of child-bearing potential and males should be willing to use adequate methods of contraception
- •9. Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1. Subjects using fixed orthodontic appliances
- •2. Subjects on drugs for xerostomia, e.g. pilocarpine or cevimeline
- •3. Subjects who are allergic to any of the ingredients of the study product
- •4. Subjects who have undergone long term antibiotic therapy (for 30 days or more in the past three months)
- •5. Subjects who are smokers or current users of narcotics
- •6. Subjects using commercial mouthwash, antibacterial tooth paste and dental floss
- •7. Subjects who are consuming probiotics products in any formats
- •8. Pregnant or lactating women
- •9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
研究者
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