An Open-Label, Single-Arm, Single-Centre, Prospective, Interventional Clinical Study to Evaluate the Safety and Efficacy of a Teeth Whitening Toothpaste in Healthy Adults with A2 or Darker Tooth Colour.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Naturelle LLC,
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. To evaluate the effectiveness of the test product in terms of change in whiteness of the teeth from baseline before and after usage of the test product.
Overview
Brief Summary
This is an open-label, single-arm, single-centre, prospective, interventional, clinical safety and efficacy study of Teeth whitening toothpaste in healthy adult subjects with A2 or darker tooth colour.
A total of 32 subjects, including males and non-pregnant, non-lactating females aged between 18 to 55 years (both inclusive), will be enrolled to complete 30 subjects in the study.
The potential subjects will be screened as per inclusion and exclusion criteria after obtaining written informed consent from the subjects. Subjects will be contacted telephonically by the screening department of NovoBliss Research prior to the enrolment visit. Subjects will be instructed to visit the facility as per below visits:
ü Visit 01 (Day 01): Screening and Enrolment, Baseline Evaluations, Product Usage Period and T1 min Post Usage Evaluation.
ü Visit 02 Day 07 (± 2 days): Product Usage period and Evaluations
ü Visit 03 Day 30 (± 2 days): Product Usage Evaluations and End of Study
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age: 18 to 55 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.
- •Subjects are generally in good general health as determined from recent medical history.
- •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.
- •Subjects who are Pan/Gutka eaters, smokers and have extrinsic stain intensity score more than 1 in extrinsic stain index.
- •Subjects having 6 present upper front teeth.
- •No previous whitening products | product and no restorations (anterosuperior group).
- •No cervical lesions, or dental pain.
- •Subjects who agree to discontinue the use of over-the-counter teeth whitening product throughout the study.
Exclusion Criteria
- •Subjects who are undergoing product for gingivitis, periodontitis, or caries.
- •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 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 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 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/whitening products.
- •Subjects have any known allergies to the test product ingredients.
- •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.
- •Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
Outcomes
Primary Outcomes
1. To evaluate the effectiveness of the test product in terms of change in whiteness of the teeth from baseline before and after usage of the test product.
Time Frame: from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) and Day 30 (±2 Days). | from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) and Day 30 (±2 Days).
2. To evaluate the effectiveness of the test product in terms of change in extrinsic stains from baseline before and after usage of the test product.
Time Frame: from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) and Day 30 (±2 Days). | from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) and Day 30 (±2 Days).
Secondary Outcomes
- 1. To evaluate the effectiveness of test product in terms of change in plaque deposition from baseline before & after usage of the test product.(from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) & Day 30 (±2 Days).)
- 2. To evaluate the effectiveness of test product in terms of change in gingivitis from baseline before & after usage of the test product.(from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) & Day 30 (±2 Days).)
- 3. To evaluate the effectiveness of test product in terms of change in freshness of breath from baseline before & after usage of the test product.(from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) & Day 30 (±2 Days).)
- 4. To evaluate the effectiveness of test product in terms of change in visual appearance of teeth from baseline before & after usage of the test product.(from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) & Day 30 (±2 Days).)
- 5. To evaluate the effectiveness of test product in terms of change in subject perception questionnaire from baseline before & after usage of the test product.(from baseline on Day 01, prior to test product usage to post product usage assessments on Day 01 at T1 mins, Day 07 (±2 Days) & Day 30 (±2 Days).)
Investigators
Dr Darshan Patel
NovoBliss Research Private Limited