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
- 2/3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- •Significant reduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator.
研究概览
简要总结
The current clinical study is planned to compare the efficacy and safety of an oral care product in reducing the oral malodour in comparison to a marketed comparator. The study is planned in male and female healthy subjects aged 18-55 years having clinically diagnosed oral malodour. Both microbiological and biochemical parameters are used to assess the reduction in oral malodor. Assessment is done forrReduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator and reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator. Other key parameters of oral hygiene like plaque index, gingival index, gum bleeding index and oral hygiene index will be assessed for reduction at various time points in comparison to baseline and marketed comparator. The sample size of for each group will be 30 completed subjects and study intervention period will be one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Having at least 16 natural, permanent teeth.
- •â€¢Subjects with bad oral hygiene and halitosis (self-reported or clinically diagnose).
- •Subjects who have plague and dental caries.
- •â€¢Subjects willing to give their swab samples for analysis.
- •â€¢Subjects willing to follow 12 hr.
- •â€¢Subjects willing to come for follow up visits at the specified time.
- •â€¢Subjects ready to follow instructions during the study period.
- •â€¢Subjects who use oral hygiene products other than Dabur.
- •â€¢Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
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.
- •Subjects having moderate to severe dentine hypersensitivity.
- •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 use of smokeless tobacco products.
- •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
•Significant reduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator.
时间窗: Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr
•Significant reduction (X%) in oral microflora with product use and with comparator.
时间窗: Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr
•Significant reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator.
时间窗: Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr
次要结局
- •Significant reduction in plaque, gingivitis, bleeding index and oral hygiene index with regular use of test product at various time points in comparison to the baseline and with comparator.