| CTRI Number |
CTRI/2025/06/088879 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical safety and efficacy study of teeth sensitivity toothpaste containing 5 percent potassium nitrate + Inulin in healthy adult subjects with dentine hypersensitivity. |
|
Scientific Title of Study
|
An open-label, single-arm, clinical study to evaluate the safety and efficacy of a teeth sensitivity toothpaste containing 5 percent potassium nitrate plus Inulin in healthy adult subjects with dentine hypersensitivity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250018-DUAE Ver 1.0 16 May 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jahanvi Chavda MDS Periodontist |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota,
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
jahanvichavda0702@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Sub Investigator |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayanpatel@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Naturelle LLC
Emirates Link Road,
Al Jazeera Al Hamra Industrial Area
P.O. Box: 6399, Ras AI Khaimah U.A.E
|
|
|
Primary Sponsor
|
| Name |
Naturelle LLC |
| Address |
Emirates Link Road,
Al Jazeera Al Hamra Industrial Area
P.O. Box: 6399, Ras AI Khaimah U.A.E
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jahanvi Chavda |
NovoBliss Research Private Limited |
Clinical Trial Department NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT |
07948983895
jahanvichavda0702@gmail.com |
| Dr Jahanvi Chavda |
VRAJ Dental Clinic |
FF5, Shukan Platinum, Vandematram Crossroad,
New SG Rd, Gota, Ahmedabad 382481, Gujarat, India.
Ahmadabad
GUJARAT |
7948983895
consultant@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dentine
Hypersensitivity Toothpaste |
Apply a pea-sized amount of toothpaste on the toothbrush bristles. Angle the toothbrush at 45 degrees to your gums and gently move it back and forth to clean your front teeth. Duration of Study 60 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
5)Subjects with a plaque index and gingivitis index score greater than 2 during screening.
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.
|
|
| ExclusionCriteria |
| Details |
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.
16)Subjects having bridgework in their teeth and dentures which interrupt during evaluation.
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
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.
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.
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
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |