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
- 试验地点
- 2
- 主要终点
- Effect assessed in terms of mean reduction in halimeter readings of T-VSC (total volatile sulphur compounds) between the groups
研究概览
简要总结
This will be a randomized, placebo-controlled, double blind study with three parallel arms. Subjects will be randomly assigned equally to one of three groups. One group will be given placebo gums and the remaining two groups will be given different sets of gums containing actives. Approximately 78 subjects will be enrolled from 1 participating center in India. The primary objective of this study will be to evaluate the effect on reduction in volatile sulphur compounds in oral cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females, more than or equal to 18 years to less than or equal to 50 years of age
- •Halimeter reading of T-VSC (total volatile sulphur compounds) of 200 ppb (parts per billion) or more
- •Salivary levels of S.
- •mutans more than 10,000 CFU/mL
- •Subjects with non-compromised oral health – Subjects should not have untreated caries lesions, clinical signs of gingivitis or periodontal disease, orthodontic patients, oral carcinoma, etc.
- •Subjects not undergoing antibiotic or antimicrobial therapy
- •Subjects willing to use standard toothpaste and toothbrush provided to them, throughout the study
- •Subjects willing to use a tongue cleaner provided to them, throughout the study
- •Females of child-bearing potential and males should be willing to use adequate methods of contraception
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subjects using fixed orthodontic appliances
- •Subjects on drugs for xerostomia, e.g. pilocarpine or cevimeline
- •Subjects who are allergic to any of the ingredients of the study product
- •Subjects who have undergone long term antibiotic therapy (for 30 days or more in the past three months)
- •Subjects who are smokers or current users of narcotics
- •Subjects using commercial mouthwash, antibacterial tooth paste and dental floss
- •Pregnant or lactating women
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Effect assessed in terms of mean reduction in halimeter readings of T-VSC (total volatile sulphur compounds) between the groups
时间窗: From baseline, Day 1 to Day 15
次要结局
- Reduction in counts of S. mutans between the groups(From baseline, Day 1 to Day 15 and Day 21)
- Mean reduction in halimeter readings of T-VSC between the groups(From baseline, Day 1 to Day 21)
- Mean reduction in organoleptic measurements between the groups(From baseline, Day 1 to Day 15 and Day 21)
- Reduction in counts of P.gingivalis between the groups(From baseline, Day 1 to Day 15 and Day 21)
- Reduction in counts of C.albicans between the groups(From baseline, Day 1 to Day 15 and Day 21)
- Increase in salivary counts of Lactobacilli sp.(From baseline, Day 1 to Day 15 and Day 2)
- Improvement in QOL affected by oral malodour(From baseline, Day 1 to Day 15 and Day 21)
- Improvement in subject-satisfaction after using the investigational products.(From baseline, Day 1 to Day 15 and Day 21)
研究者
研究点 (2)
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