Assessment of Safety and Up to 12 hours Long-Lasting Fresh Breath Efficacy of the Test Product with Single Use in Healthy Adult Subjects with Oral Malodour: An Open-Label, Single-Arm, Single-Centre, Prospective Interventional Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of the test product in terms of change in Halitosis from baseline using Halimeter.
研究概览
简要总结
Assessment of Safety and Up to 12 hours Long-Lasting Fresh Breath Efficacy of the Test Product with Single Use in Healthy Adult Subjects with Oral Malodour: An Open-Label, Single-Arm, Single-Centre, Prospective Interventional Clinical Study.
Duration will be approximately 28 days if applicable.
Visit 01: Screening, ICD, Evaluation.
Visit 02: Enrolment, Evaluations, End of Study.
Visit 03: Evaluations End of Study (if applicable)
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 65 years (both inclusive) old at the time of consent in the following manner: a.10 subjects aged 18 to 35 years b.10 subjects aged 36 to 50 years c.10 subjects aged 51 to 65 years 2)Sex: Healthy adult males and non-pregnant/non-lactating females.
- •Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- •Subjects are generally in good general health as determined from recent medical history.
- •Subjects having score of 3 or more than 3 in Organoleptic assessment.
- •Subjects having score of 2 or more than 2 in assessment by Tanita.
- •Subjects having score of more than 140 ppb in Halimeter.
- •Subjects with no tooth sensitivity during screening.
- •No cervical lesions, or dental pain.
- •Subjects who agree to discontinue the use of over-the-counter breath freshness products (mouthwash, gargles, mouth spray, chewing gum, etc) throughout the trial.
- •Subjects who agree to discontinue the use of any other oral care product like mouth wash, oil pull, any medicated gargle, mouth sprays, any tooth gel or chewing gums etc.
- •throughout the trial.
- •Agree not to participate in any other oral/dental product studies during the trial.
- •Agree to return for all scheduled visits and follow study procedures.
- •Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- •Subjects who can read, sign, and receive a copy of informed consent before on of study procedures.
排除标准
- •Subjects who are undergoing treatment for gingivitis, periodontitis, or caries.
- •Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
- •Subjects who are Pan/Gutka eaters and smokers.
- •Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
- •Subjects have any known allergies to over-the-counter oral products.
- •Subjects have any known allergies to the trial product ingredients.
- •Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
结局指标
主要结局
1. To evaluate the effectiveness of the test product in terms of change in Halitosis from baseline using Halimeter.
时间窗: 1. At Day 01 before test product usage and after test product usage at T0 plus 5 mins and T12 hours on Day 01 and on Day 28 (if applicable) | 2. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable) | 3. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable)
2. To assess the effectiveness of the test product in terms of change in Halitosis/malodour from baseline using Tanita.
时间窗: 1. At Day 01 before test product usage and after test product usage at T0 plus 5 mins and T12 hours on Day 01 and on Day 28 (if applicable) | 2. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable) | 3. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable)
3. To evaluate the effectiveness of the test product in retaining freshness after 1st usage of the test product from baseline using organoleptic assessment scale by Dentist.
时间窗: 1. At Day 01 before test product usage and after test product usage at T0 plus 5 mins and T12 hours on Day 01 and on Day 28 (if applicable) | 2. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable) | 3. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable)
次要结局
- To evaluate the effectiveness of the test product in terms of change subject perception questionnaires after test product usage, using the 5-point scoring scale.(After usage of the test product at T0 at 5mins and T12 hours on Day 01 and on Day 28 (if applicable))
研究者
Dr Pushti Purohit MDS Periodontist
NovoBliss Research Private Limited