CTRI/2024/10/074766 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On:
04/03/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Dentistry
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
A clinical study to determine the safety and efficacy of two different teeth whitening test products (Toothpaste and Teeth Whitening Serum) in healthy human subjects.
Scientific Title of Study
An Exploratory, Open-Label, Parallel, Two-Arm, Prospective, Interventional Study to Evaluate the Safety, Efficacy, and Tolerability of Two Different Teeth Whitening Products (Dream White Toothpaste and Teeth Whitening Serum) in Healthy Adults with Dark Tooth Color (A2 or Darker for toothpaste and B2, B3 or B4 for teeth whitening serum).
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NB240045-PI, 1.0, 10Sep24
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Darshan Patel
Designation
BDS (Dentist)
Affiliation
NovoBliss Research Private Limited
Address
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
NA Gandhinagar GUJARAT 382421 India
Phone
917948983895
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, NA 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, NA Gandhinagar GUJARAT 382421 India
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gandhinagar GUJARAT
9909013286
dr.nayan@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
Status
Not Applicable
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
Intervention
Dream White Toothpaste
Mode of Application: Wet your brush and then apply required amount of paste. Brush it for 2-3 mins.
Frequency: Twice a Day for consecutive 60 Days.
Route of Administration: Topical (Dental)
Comparator Agent
NA
Nil
Intervention
Purple Magic Teeth Whitening Serum (Teeth Color Corrector Formula)
Mode of Application: Wet your brush and then apply required amount of serum. Brush it for 2-3 mins.
Frequency: Twice a Day for consecutive 60 Days.
Route of Administration: Topical (Dental)
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) Subjects with visible yellowish discoloration of teeth (eg. By consuming coffee 2-3 times a day).
6) Tooth colour value of B2, B3 or B4 (VITA Easyshade Advance 5.0), which was determined on the middle third of the vestibular surface of the maxillary lateral incisors by the Dentist
7) Subjects having 6 present upper front teeth.
8) No previous whitening treatments | product and no restorations (anterosuperior group).
9) No cervical lesions, or dental pain.
10) Subjects who agree to discontinue the use of over-the-counter teeth whitening products throughout the trial.
11) 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.
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.
16) 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 teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
7) Subjects have any known allergies to over-the-counter oral hygiene/whitening products.
8) Subjects have any known allergies to the trial product ingredients.
9) 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.
10) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
11) Pregnant or breastfeeding or planning to become pregnant during the study period.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
For Toothpaste
1.change in whiteness of the teeth from baseline before and after usage of the test product.
2.change in extrinsic stains from baseline before and after usage of the test product.
For Serum
1.change in whiteness of the teeth from baseline before and after usage of the test product.
2.change in extrinsic stains from baseline before and after usage of the test product.
For Toothpaste
1. Day 1 before test product usage to Day 1 after test product usage, Day 30 and on Day 60.
2. Day 1 before test product usage to Day 1 after test product usage, Day 30 and on Day 60.
For Serum
1. Day 1 before test product usage to Day 1 after test product usage, Day 08, and Day 15.
2. Day 1 before test product usage to Day 1 after test product usage, Day 08 and on Day 15.
Secondary Outcome
Outcome
TimePoints
1.Subject perception questionnaires on the taste & fresh sensation after usage of the test product.
1. After using the test product at T0 minutes, & questionnaires on the fresh sensation will be administered at T0 minutes, T30 minutes, & T60 minutes on Day 01.
2. Subject perception questionnaires after usage of the test product.
For toothpaste
Day 01 at T60 minutes, Day 30, & Day 60.
For Serum
Day 01 at T60 minutes, Day 08, & Day 15.
Target Sample Size
Total Sample Size="64" Sample Size from India="64" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
N/A
Date of First Enrollment (India)
15/10/2024
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)?
Purple Magic Teeth Whitening Serum: This clinical study was an exploratory, open-label, parallel, prospective, interventional investigation conducted to evaluate the safety, efficacy, and in-use tolerability of Purple Magic Teeth Whitening Serum in healthy adults with dark-shaded teeth. Registered with the Clinical Trial Registry of India (CTRI/2024/10/074766) on October 4, 2024, the study enrolled 40 subjects aged 18 to 55 years, with 32 successfully completing the study. Written informed consent was obtained from all participants after a detailed explanation of the study procedures, and copies of the consent forms were provided to the subjects. The study design included three visits: Visit 01 (Day 01), which involved screening, baseline evaluations, initial product application, and post-use assessment; and follow-up visits on Day 08 (+2 days) and Day 15 (+2 days). The primary objectives were to evaluate improvements in tooth whiteness and the reduction of extrinsic stains. Additionally, subjects completed a questionnaire assessing their perceptions of tooth color improvement, cleanliness, uniformity of tooth color, overall satisfaction, taste, and freshness after using the product.
Instrumental evaluations were conducted using the Vita Easyshade and Classic Vita Shade Guide (VITA Zahnfabrik H. Rauter GmbH & Co. KG) to measure tooth color improvement precisely. Dentists assessed extrinsic stains using the Lobene Stain Index to ensure thorough evaluation of stain reduction. All raw data were meticulously reviewed, and statistical analyses were performed using IBM® SPSS® (Version 29.0.1.0(171)) and Excel, with a 5% level of significance ensuring robust interpretation. Purple Magic Teeth Whitening Serum is uniquely formulated to enhance tooth whiteness and overall dental health. Its active ingredients include Nano Hydroxyapatite, which restores and strengthens enamel; Bromelain and Papain enzymes, which break down stains and plaque while providing mild exfoliation; Apple and Peach fruit extracts, which promote dental health; Peppermint and Spearmint, which enhance oral hygiene and provide a fresh sensation; and ImerCare® PerlWhite19, which visibly whitens teeth and aids in color correction.
The study demonstrated significant improvements in teeth whiteness, color uniformity, and reduction of extrinsic stains. Objective results showed a marked increase in the L* value, indicating a substantial enhancement in teeth whiteness from baseline to Day 15. Subjects reported high satisfaction with the product’s whitening effects, taste, and fresh sensation. No adverse effects were observed, confirming the safety of the product for healthy individuals. In conclusion, Purple Magic Teeth Whitening Serum proved to be a safe and effective solution for improving teeth whiteness, reducing stains, and enhancing overall tooth appearance. Its innovative formulation and demonstrated efficacy position it as a valuable addition to oral health care regimens for individuals seeking effective teeth whitening and stain reduction.
Dream White Toothpaste : This clinical study was designed as an exploratory, open-label,
parallel, prospective, interventional investigation to assess the safety,
efficacy, and in-use tolerability of Dream White Toothpaste in healthy adults
with dark-shaded teeth. The study was registered with the Clinical Trial
Registry of India (CTRI/2024/10/074766) on October 4, 2024. A total of 32
subjects, aged 18 to 55 years were enrolled, with 30 subjects completing the
study. Written informed consent was obtained from all participants after a comprehensive
explanation of the study procedures, and copies of the consent forms were provided.
The study design included three scheduled visits, Visit 01 involved
screening, baseline assessments, test product application, and post-use
evaluation. Follow-up assessments were conducted on Day 30 ±2 days and Day 60
±2 days to monitor key safety and efficacy parameters, including improvements
in teeth whiteness and reductions in extrinsic stains. Participants completed questionnaires
evaluating changes in tooth color, cleanliness, uniformity, and overall
satisfaction with the test product.
Tooth color improvements were objectively measured using instrumental
evaluations with Vita Easyshade V and the Classic Vita Shade Guide (VITA
Zahnfabrik H. Rauter GmbH & Co. KG Spitalgasse 3, V512bLE). Extrinsic stain
reduction was assessed through dentist evaluations using the Lobene Stain
Index, ensuring a comprehensive analysis of stain reduction. All raw data were reviewed,
and statistically analysed using IBM® SPSS® (Version 29.0.1.0(171)) and Microsoft® Excel, with a 5% level of significance ensuring rigorous data
interpretation.
The study findings indicate a progressive improvement in teeth whiteness
& a reduction in stain intensity over the study period. No treatment-related
adverse effects were observed, suggesting that Dream White Toothpaste is safe
for regular use. The results support that the
toothpaste may contribute to improved tooth whiteness and effective stain
reduction, with favourable tolerability and overall participant satisfaction.