| CTRI Number |
CTRI/2023/12/060417 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study of the test product in healthy human subjects |
|
Scientific Title of Study
|
An open label, randomized, assessor blind, four-arms, prospective, interventional, comparative, clinical study to assess the safety, efficacy, tolerability of teeth whitening toothpastes in healthy adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230039-DI Version 01 (Final) 09 Nov 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jahanvi Chavda |
| Designation |
Principal Investigator |
| Affiliation |
Vraj Dental Clinic |
| Address |
Vraj Dental Clinic, FF 5, Shukan Platinum, Vandematram Cross Road, New S.G. Road, Gota, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
drjahanvichavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| 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 |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited, Oral Care Division- DRDC, Dabur Research & Development Center, 22, Site IV, Sahibabad, Industrial Area, Ghaziabad, Uttar Pradesh 201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur India Limited, Oral Care Division- DRDC, Dabur Research & Development Center, 22, Site IV, Sahibabad, Industrial Area, Ghaziabad, Uttar Pradesh 201010 |
| Type of Sponsor |
Other [Healthcare and FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jahanvi Chavda |
VRAJ Dental Clinic |
F-F-5, Shukan Platinum, Vandematram Crossroad,
New SG Rd, Gota, Ahmedabad 382481,
Gujarat – India
Gandhinagar
GUJARAT |
07948983895
drjahanvichavda@gmail.com |
|
|
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: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Charcoal Gel toothpaste 1
|
Mode of Application: 2-3 g twice daily, to be adequately applied on the toothbrush and brush the teeth for at least 2 minutes for better cleaning. Route of Administration: Topical
Duration: 28 days |
| Intervention |
Charcoal Gel toothpaste 2 |
Mode of Application: 2-3 g twice daily, to be adequately applied on the toothbrush and brush the teeth for at least 2 minutes for better cleaning. Route of Administration: Topical Duration: 28 days |
| Comparator Agent |
Marketed Charcoal Gel Toothpaste |
Mode of Application: 2-3 g twice daily, to be adequately applied on the toothbrush and brush the teeth for at least 2 minutes for better cleaning. Route of Administration: Topical Duration: 28 days |
| Comparator Agent |
Marketed Ordinary Gel Toothpaste |
Mode of Application: 2-3 g twice daily, to be adequately applied on the toothbrush and brush the teeth for at least 2 minutes for better cleaning. Route of Administration: Topical Duration: 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18 to 55 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)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.
6)Subjects who are Pan/Gutka eaters, smokers and have extrinsic stain intensity score more than 1 in extrinsic stain index.
7)Subjects having score of more than 0 in TANITA breath analyser.
8)Subjects having score of more than 1 in plaques index and gingival index.
9)Subjects with no tooth sensitivity during screening.
10)Subjects having 6 present upper front teeth.
11)No previous whitening treatments | products and no restorations (anterosuperior group).
12)Anterior teeth without restorations.
13)No cervical lesions, or dental pain.
14)Subjects who agree to discontinue the use of over-the-counter teeth whitening products throughout the trial.
15)Subjects who agree to discontinue the use of any other oral care product except the test products like mouth wash, oil pull, any medicated gargle, mouth sprays, any tooth gel or whitening chewing gums etc. throughout the trial.
16)Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
17)Agree not to participate in any other oral/dental product studies during the trial.
18)Agree to return for all scheduled visits and follow study procedures.
19)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
20)Subjects who can read, sign, and receive a copy of Informed Consent before on of study procedures.
|
|
| ExclusionCriteria |
| Details |
1)Subjects who are undergoing treatment for gingivitis, periodontitis, or caries.
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 maxillary 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/whitening products.
9)Subjects have any known allergies to the trial product ingredients.
10)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.
11)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
12)Pregnant or breastfeeding or planning to become pregnant during the study period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effectiveness of the test products in terms of change in whiteness and shine of the teeth and prevention of yellowing of teeth with regular use.
2.To evaluate the effectiveness of the test products in terms of change in extrinsic stains.
3.To evaluate the full coverage, powerful, gentle cleaning of teeth by test products in terms of plaque reduction and prevention of plaque formation with regular use.
4.To evaluate the full coverage, powerful, gentle cleaning of teeth by test products in terms of gingivitis reduction and prevents gingivitis with regular use.
5.To assess the effect of test product in improving the mild-moderate halitosis.
|
From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 05 (only whitening), Day 07, Day 14 and on Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of test products in providing protection against the effect of teeth sensitivity, acid erosion of tooth enamel |
From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28 |
| To assess the effect of test products in terms of change in color of the tooth |
From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28 |
| To assess the effect of test products in terms of change in mal-odor |
From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28 |
| To assess the effectiveness of the test products through consumer perception questionnaire |
From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28 |
| Subject perception questionnaires on the taste and fresh sensation |
After test product usage at 0 mins, 30 mins and 60 mins (±5 mins) on Day 1 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2023 |
| Date of Study Completion (India) |
25/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 an open-label, randomised, four-arms, prospective, interventional, comparative clinical study to assess safety, efficacy, in-use tolerability of teeth whitening - test toothpastes in healthy human adult subjects. The sample size is considered 140. Subjects will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening and Enrolment, baseline evaluations Visit 02 (Day 03): Test product usage, evaluations Visit 03 (Day 05): Test product usage, evaluations Visit 04 (Day 07): Test product usage, evaluations Visit 05 (Day 14): Test product usage, evaluations Visit 06 (Day 28): Evaluations, end of study
|