A clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy adult subjects with plaque, oral malodor and bleeding gums.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the effect of the test product on the
研究概览
简要总结
This is an open label, non-randomized, single-centre, single-arm clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy adult subjects with plaque, oral malodor and bleeding gums.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo clinical evaluation by a Dentist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with mild, moderate or severe plaque with plaque index of 2, 3 and
- •Subjects with gingivitis and having extrinsic dental stains.
- •Subjects having T-VSC reading (total volatile sulphur compounds) of ≥140 ppb (parts per billion).
- •Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visit.
- •Subjects should be willing to not consume anything except water after meal of previous night.
排除标准
- •Subjects with plaque index of 0, 1 and
- •Subject with orthodontic bands.
- •Subject having tumor (s) of the soft or hard tissues of the oral cavity.
- •Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- •Subject with five or more carious lesions requiring immediate restorative treatment.
结局指标
主要结局
To assess the effect of the test product on the
时间窗: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).
reduction in gingivitis using Gingival index
时间窗: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).
次要结局
- To assess the effect of the test product on the reduction in plaque by using plaque index and disclosing agents(Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).)
- To assess the effect of the test product on the reduction in T-VSC reading (total volatile sulfur compounds) using a Halimeter:(Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins) and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01.)
- To assess the effect of the test product on Germ Protection by microbial analysis for S. mutans(Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins), and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01.)
- To assess the effect of the test product on Number of carious tooth by dental examination(Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).)
- Subjective evaluation questionnaire(Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).)
- Subjects’ perception questionnaires(0 mins (plus 5 mins), 30 mins (plus 5 mins) and 60 mins (plus 5 mins)on Day 01 and Day 30 (plus 2 days).)
研究者
Dr Parth Joshi
Cliantha Research