CTRI/2023/12/060417招募中Unknown
An open label, randomized, assessor blind, four-arms, prospective, interventional, comparative, clinical study to assess the safety, efficacy, tolerability of teeth whitening toothpastes in healthy adults - NI
试验速览
- 阶段
- Unknown
- 状态
- 招募中
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 55 years (both inclusive) old at the time of consent.
- •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)Tooth colour value of A2 or Darker (VITA Easyshade Advance 5.0), which was determined on the middle third of the vestibular surface of the maxillary lateral incisors by the Dentist.
- •6)Subjects who are Pan/Gutka eaters, smokers and have extrinsic stain intensity score more than 1 in extrinsic stain index.
- •7)Subjects having score of more than 0 in TANITA breath analyser.
- •8)Subjects having score of more than 1 in plaques index and gingival index.
- •9)Subjects with no tooth sensitivity during screening.
- •10)Subjects having 6 present upper front teeth.
- •11)No previous whitening treatments | products and no restorations (anterosuperior group).
- •12)Anterior teeth without restorations.
- •13)No cervical lesions, or dental pain.
- •14)Subjects who agree to discontinue the use of over-the-counter teeth whitening products throughout the trial.
- •15)Subjects who agree to discontinue the use of any other oral care product except the test products like mouth wash, oil pull, any medicated gargle, mouth sprays, any tooth gel or whitening chewing gums etc. throughout the trial.
- •16)Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
- •17)Agree not to participate in any other oral/dental product studies during the trial.
- •18)Agree to return for all scheduled visits and follow study procedures.
- •19)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- •20)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 fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- •3)Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
- •4)Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, 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 subject might be compromised.
- •5)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.
- •6)Subjects have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
- •7)Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
- •8)Subjects have any known allergies to over-the-counter oral hygiene/whitening products.
- •9)Subjects have any known allergies to the trial product ingredients.
- •10)The subject must not have participated in a clinical study with oral care or oral hygiene within 4 weeks before the screening visit of this study.
- •11)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
- •12)Pregnant or breastfeeding or planning to become pregnant during the study period.
研究者
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