| CTRI Number |
CTRI/2024/07/071115 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dental sensitivity toothpastes: a clinical safety and effectiveness investigation conducted on healthy adult participants. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240025-DI version 1.0 25Jun24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushti Purohit MDS Periodontist |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub- Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gujarat – India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited,
22, Site IV, Sahibabad Industrial Area, Ghaziabad,
Uttar Pradesh 201010
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
22, Site IV, Sahibabad Industrial Area, Ghaziabad,
Uttar Pradesh 201010
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pushti Purohit |
NovoBliss Research Pvt. Limited |
clinical trial department
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT |
7948983895
consultant@novobliss.in |
| Dr Pushti Purohit |
VRAJ Dental Clinic |
VRAJ Dental Clinic
F-F-5, Shukan Platinum, Vandematram Crossroad,
New SG Rd, Gota, Ahmedabad 382481,
Gujarat – India
Ahmadabad
GUJARAT |
7948983895
consultant@novobliss.in |
|
Details of Ethics Committee
Modification(s)
|
| 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: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Test Treatment A - 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.
Dose: Required amount(1-2 gm)
Dosage: semi solid form
Frequency :Twice a Day (Morning and Before Bed)
Route of Administration : Topical
Total Duration- 61 Days |
| Intervention |
Test Treatment B- 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. Dose: Required amount(1-2 gm) Dosage: semi solid form Frequency :Twice a Day (Morning and Before Bed) Route of Administration : Topical
Total Duration- 61 Days |
| Intervention |
Test Treatment C - 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. Dose: Required amount(1-2 gm) Dosage: semi solid form Frequency :Twice a Day (Morning and Before Bed) Route of Administration : Topical
Total Duration- 61 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age will be 18 to 65 years (both inclusive) old at the time of consent.
2)Sex will be 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 1 during screening.
6)Subjects having 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, antihistaminic, 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
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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)
2.To evaluate the effectiveness of the test treatments in terms of change in plaque induced gingivitis with regular use of test treatments.
3.To evaluate the effectiveness of the test treatments in terms of change in root caries with regular use of test treatments.
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.
|
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
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 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
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 |