Double-Blind, three-Arm, randomized, intervention, prospective, in-use tolerability, clinical safety and efficacy study of teeth sensitivity toothpastes in healthy adult subjects: dentine hypersensitivity testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- 1.To evaluate the effectiveness of the test treatments in terms of change in plaque deposition with regular use of test treatments. (Digital photographs of stained teeth will be taken)
研究概览
简要总结
This is double-blind, three-arm, randomized, intervention, prospective, in use tolerability, clinical safety and efficacy study of teeth sensitivity toothpaste in healthy adult subjects.
Total 4 visits were included in this study.
Visit 01 (Day 01): Screening and Enrolment, Baseline Evaluations, Treatment Usage and T1 min, T30 mins evaluation.
Visit 02 (Day 30 ± 2 days): Baseline Evaluations, Treatment Usage and T1 min, T30 mins evaluation.
Visit 03 (Day 60 ± 2 days): Before usage of test treatment evaluation, test treatment usage, T1 min, T30 mins and T12 hrs telephonic follow-up evaluation.
Visit 04 (Day 61): Before Brushing Evaluation at Morning
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 will be 18 to 65 years (both inclusive) old at the time of consent.
- •Sex will be 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 hypersensitive tooth during screening.
- •Subjects having root caries at time of screening.
- •Subjects having 6 present upper front teeth.
- •Anterior teeth without restorations.
- •No previous treatments performed on tooth.
- •Subjects who agree to discontinue the use of over-the-counter any teeth products throughout the trial.
- •Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
- •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.
排除标准
- •Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
- •Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
- •Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
- •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.
- •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 have meaningful malocclusion that would impact treatment or ease of viewing/scoring anterior teeth.
- •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 hygiene/ products.
- •Subjects have any known allergies to the trial product ingredients.
- •The subject 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.
- •Subjects who smoke and are pan eaters.
- •Subjects having chipped teeth and defective restorations.
- •Subjects having deep periodontal pockets.
- •Subjects having bridgework in their teeth and dentures which interrupt during evaluation.
- •Subjects undergoing treatment with antibiotics, anti-inflammatory, anticonvulsants, antihistaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
- •Subjects having uncontrolled metabolic disease.
- •Subjects overexposure to acidic by dietary and environment exposure.
结局指标
主要结局
1.To evaluate the effectiveness of the test treatments in terms of change in plaque deposition with regular use of test treatments. (Digital photographs of stained teeth will be taken)
时间窗: Baseline before usage of the test treatments and after usage of test | treatments at T1 min, T30 mins on Day 01, before usage of the test | treatments and after usage of test treatments at T1 min, T30 mins on | Day 30 , before usage of the test treatments and after usage | of test treatments at T1 min, T30 mins on Day 60 and on Day | 61 before brushing at morning
2.To evaluate the effectiveness of the test treatments in terms of change in plaque induced gingivitis with regular use of test treatments.
时间窗: Baseline before usage of the test treatments and after usage of test | treatments at T1 min, T30 mins on Day 01, before usage of the test | treatments and after usage of test treatments at T1 min, T30 mins on | Day 30 , before usage of the test treatments and after usage | of test treatments at T1 min, T30 mins on Day 60 and on Day | 61 before brushing at morning
3.To evaluate the effectiveness of the test treatments in terms of change in root caries with regular use of test treatments.
时间窗: Baseline before usage of the test treatments and after usage of test | treatments at T1 min, T30 mins on Day 01, before usage of the test | treatments and after usage of test treatments at T1 min, T30 mins on | Day 30 , before usage of the test treatments and after usage | of test treatments at T1 min, T30 mins on Day 60 and on Day | 61 before brushing at morning
4.To evaluate the effectiveness of the test treatments in terms of change in teeth sensitivity assessed by techniques like air-blast, cold thermal stimuli and 20% acid solution (lemon solution) with regular use of test treatments.
时间窗: Baseline before usage of the test treatments and after usage of test | treatments at T1 min, T30 mins on Day 01, before usage of the test | treatments and after usage of test treatments at T1 min, T30 mins on | Day 30 , before usage of the test treatments and after usage | of test treatments at T1 min, T30 mins on Day 60 and on Day | 61 before brushing at morning
次要结局
- 1. To assess the effectiveness of the test treatments in terms of subject treatment perception questionnaire.(Baseline before usage of the test treatments and after usage of test)
研究者
Dr Pushti Purohit MDS Periodontist
NovoBliss Research Private Limited