CTRI/2026/07/113300进行中（未招募）不适用
A Randomized, Double-Blind, Two-arm, Prospective Interventional Clinical Study to Evaluate In-Use Tolerability, Safety and Efficacy of Toothpastes for Germ Killing and Oral FRESHness Effects in Healthy Adult Participants. - FRESH
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •Age: 18 to 65 years (both inclusive) old at the time of consent.
- •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.
- •Participants are generally in good general health as determined from recent medical history.
- •Participants with an oral malodour during screening.
- •Participants having oral plaque and gingivitis.
- •Participants having 6 present upper front teeth.
- •Anterior teeth without restorations.
- •Participants who agree to discontinue the use of over-the-counter any teeth products throughout the study.
- •Participants who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
- •Participants who agree not to participate in any other oral/dental product studies during the study.
- •Participants who agree to return for all scheduled visits and follow study procedures.
- •Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
排除标准
- •Participants who are undergoing product for gingivitis, caries, dental plaque and malodour.
- •Participants are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- •Participants have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
- •Participants have any oral pathologies or gross neglect of home care requiring prompt product, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that participants might be compromised.
- •Participants are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the participants at increased health risk from study participation.
- •Participants have meaningful malocclusion that would impact product or ease of viewing/scoring anterior teeth.
- •Participants have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
- •Participants have any known allergies to over-the-counter oral hygiene/ products.
- •Participants have any known allergies to the study product ingredients.
- •The participants must have participated in a clinical study with oral care or oral hygiene within 4 weeks before the screening visit of this study.
- •Any other condition which could warrant exclusion from the study, as per the investigator s discretion
- •Participants who smoke and are pan eaters.
- •Participants having bridgework in their teeth and dentures which interrupt during evaluation.
- •Participants undergoing periodontal surgery within previous 6 months.
- •Participants undergoing product with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
- •Participants overexposure to acidic by dietary and environment exposure.
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