Clinical safety and efficacy study of teeth sensitivity toothpaste containing 5 percent potassium nitrate + Inulin in healthy adult subjects with dentine hypersensitivity.

Not yet recruiting

Conditions: Disease of hard tissues of teeth,unspecified,

Registration Number: CTRI/2025/06/088879

Lead Sponsor: Naturelle LLC

Brief Summary: An open-label, single-arm, clinical study to evaluate the safety and efficacy of a teeth sensitivity toothpaste containing 5% potassium nitrate + Inulin in healthy adult subjects with dentine hypersensitivity

· Visit 01 (Day 01): Screening and Enrolment, Baseline Evaluations, Product Usage Period and T1 min, T30 mins Post Usage Evaluation.

· Visit 02 [Day 02 (24 hours ±2 hours)]: Baseline evaluation, Test Product Usage Period, T1 min and T30 mins Evaluations

· Visit 03 (Day 30 ±2 days): Before Brushing Evaluation at Morning, Test Product Usage Period, T1 min and T30 mins Evaluations

· Visit 04 (Day 59): Before Brushing Evaluation at Morning, Product Usage and T1 min, T30 mins Post Usage Evaluation

· Visit 05 (Day 60): Before Brushing Evaluation at Morning, Product Usage and T1 min, T30 mins Post Usage Evaluation

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

1)Age: 18 to 65 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.
6)Subjects having mild hypersensitive tooth during screening.
7)Subjects having root caries at time of screening.
8)Subjects having 6 present upper front teeth.
9)Anterior teeth without restorations.
10)No previous treatments performed on tooth.
11)Subjects who agree to discontinue the use of over-the-counter any teeth products throughout the trial.
12)Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
13)Agree not to participate in any other oral/dental product studies during the trial.
14)Agree to return for all scheduled visits and follow study procedures.
15)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.

Exclusion Criteria

1)Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
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 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/ products.
9)Subjects have any known allergies to the trial product ingredients.
10)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.
11)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion 12)Subjects who smoke and are pan eaters.
13)Subjects with hypersensitive teeth and with mobility greater than one as per miller tooth mobility index.
14)Subjects having chipped teeth and defective restorations.
15)Subjects having deep periodontal pockets.
17)Subjects undergoing periodontal surgery within previous 6 months.
18)Subjects undergoing treatment with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
19)Subjects having uncontrolled metabolic disease.
20)Subjects overexposure to acidic by dietary and environment exposure.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the effectiveness of the test product in terms of change in plaque deposition from baseline i.e. before and after usage of test product.	1.T1 min, T30 mins on Day 01, Day 02 (, Day 30 (±2 days), Day 59 and on Day 60
2.To assess the effectiveness of the test product in terms of change in plaque induced gingivitis from baseline i.e. before after usage of test product.	1.T1 min, T30 mins on Day 01, Day 02 (, Day 30 (±2 days), Day 59 and on Day 60
3.To assess the effectiveness of the test product in terms of change in root caries from baseline i.e. before and after usage of test product.	1.T1 min, T30 mins on Day 01, Day 02 (, Day 30 (±2 days), Day 59 and on Day 60
4.To assess the effectiveness of the test product in terms of change in teeth sensitivity from baseline i.e. before usage of the test product.	1.T1 min, T30 mins on Day 01, Day 02 (, Day 30 (±2 days), Day 59 and on Day 60

Secondary Outcome Measures

Name	Time	Method
1.To assess the effectiveness of the test product in terms of subject’s product perception questionnaire from baseline i.e. before and after usage of test product.	At T1 min, T30 mins on Day 01, Day 02, Day 30 (±2 days), Day 59 and on Day 60.

Trial Locations

Locations (2): NovoBliss Research Private Limited
🇮🇳
Ahmadabad, GUJARAT, India
VRAJ Dental Clinic
🇮🇳
Ahmadabad, GUJARAT, India
NovoBliss Research Private Limited
🇮🇳Ahmadabad, GUJARAT, India
Dr Jahanvi Chavda
Principal investigator
07948983895
jahanvichavda0702@gmail.com