A Double-Blind, Randomized, Control-Arm Clinical Study to Evaluate the Safety and Efficacy of Test Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-Induced Gingivitis and Dental Plaque Accumulation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test product in terms of change in plaque deposition from baseline to post product usage, within product arm and between product arm.
研究概览
简要总结
This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy study of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation in healthy adult human subjects.
A total of 64 subjects, including males and non-pregnant, non-lactating females aged between 18 and 65 years (inclusive) with mild to moderate plaque-induced gingivitis will be enrolled to ensure 60 subjects (30 subjects/arm) to complete the study.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by recruiting department prior the enrolment visit. Study participants will be told during screening (prior to enrolment) not to use any other dental products before or during the study period.
There will be a total of 3 visits during the study. The duration of the study will be 30 Days (±2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits:
Visit 01**(Day 01):**Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage Period and T30 mins Evaluations
Visit 02 (Day 15): Test Product Usage Period, Oral Assessment
Visit 03 (Day 30): Oral Assessment, End of Study
Assessment of Efficacy parameters of product usage will be done before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days).
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: 18 to 65 years (both inclusive) old at the time of consent.
- •Sex: Healthy adult males and non-pregnant and 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 with mild to moderate gingivitis and good oral health, without hard or soft tissue lesions, with moderate gingivitis characterized by more than 30% bleeding sites and probing depths of greater than 3 mm without attachment loss.
- •Anterior teeth without restorations.
- •No dental treatments being performed before or during the study period.
- •Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.
- •Subjects who agree to discontinue the use of over-the-counter any teeth products throughout the trial except for the ADA-approved toothbrush and toothpaste provided during the study.
- •Subjects who agree to refrain from the use of any other type of floss or similar dental product during the study.
- •Agree not to participate in any other oral or 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, 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.
- •Suffering from untreated dental caries, mucosal lesions, oral tumors or severe systemic diseases that may affect periodontal diseases.
- •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 11) Subjects who smoke and are pan eaters.
- •Subjects with hypersensitive teeth.
- •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, anti-histaminic, 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
To evaluate the effectiveness of the test product in terms of change in plaque deposition from baseline to post product usage, within product arm and between product arm.
时间窗: Before and after usage of test product at T30 mins on Day 01, Day 15, and Day 30, by using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator
To evaluate the effectiveness of the test product in terms of change in plaque induced gingivitis from baseline to post product usage, within product arm and between product arm
时间窗: Before and after usage of test product at T30 mins on Day 01, Day 15, and Day 30, by using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator
次要结局
- 1. To evaluate the effectiveness of the test product by assessing change in subjective perception questionnaire from baseline to post-product usage & between test products.(1. To assess the improvement in product perception questionnaire using quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation, test product compatibility from baseline prior to usage of test product & on Day 01, Day 15, & Day 30.)
研究者
Dr Jahanvi Chavda
NovoBliss Research Private Limited