CTRI/2024/05/067622尚未招募Unknown
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. - Nil
aturelle LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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)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.
- •3)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.
- •4)Subjects are generally in good general health as determined from recent medical history.
- •5)Subjects having score of 3 or more than 3 in Organoleptic assessment.
- •6)Subjects having score of 2 or more than 2 in assessment by Tanita.
- •7)Subjects having score of more than 140 ppb in Halimeter.
- •8)Subjects with no tooth sensitivity during screening.
- •9)No cervical lesions, or dental pain.
- •10)Subjects who agree to discontinue the use of over-the-counter breath freshness products (mouthwash, gargles, mouth spray, chewing gum, etc) throughout the trial.
- •11)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.
- •12)Subjects who consent to consume the food provided by the study site.
- •13)Agree not to participate in any other oral/dental product studies during the trial.
- •14)Agree to return for all scheduled visits and follow study procedures.
- •15)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- •16)Subjects who can read, sign, and receive a copy of informed consent before on of study procedures.
排除标准
- •1)Subjects who are undergoing treatment for gingivitis, periodontitis, or caries.
- •2)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.
- •3)Subjects who are Pan/Gutka eaters and smokers.
- •4)Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
- •5)Subjects have any known allergies to over-the-counter oral products.
- •6)Subjects have any known allergies to the trial product ingredients.
- •7)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
- •8)Pregnant or breastfeeding or planning to become pregnant during the study period.
研究者
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