| CTRI Number |
CTRI/2024/05/067622 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study assessing the efficacy of the test product in maintaining long-lasting freshness of breath in healthy adult individuals experiencing oral malodour. |
|
Scientific Title of Study
|
Assessment of Safety and Up to 12 hours Long-Lasting Fresh Breath Efficacy of the Test Product with Single Use in Healthy Adult Subjects with Oral Malodour: An Open-Label, Single-Arm, Single-Centre, Prospective Interventional Clinical Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240022-DUAE_Protocol_1.0_29Apr24 |
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 – 382421, Gujarat - India
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,
Gandhinagar – 382421, Gujarat - India
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
|
| Naturelle LLC
Emirates Link Road,
AI Jazira AI Hamra Industrial Area
P.O. Box: 6399, Ras AI Khaimah U.A.E
|
|
|
Primary Sponsor
|
| Name |
Naturelle LLC |
| Address |
Emirates Link Road,
AI Jazira AI 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushti Purohit MDS |
NovoBliss Research Pvt. Limited |
Clinical Trials Department,
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT |
917948983895
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: R196||Halitosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Herbl Intense Fresh Toothpaste |
Route of Administration: Topical
Mode of Usage: Apply 2-3 gm of the test product on toothbrush in thread like layer and brush the teeth for at least 2 minutes for better freshness.
Frequency: Twice a day
Duration: 28 days |
| Comparator Agent |
NA |
NA |
|
|
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 in the following manner:
a.10 subjects aged 18 to 35 years
b.10 subjects aged 36 to 50 years
c.10 subjects aged 51 to 65 years
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 having score of 3 or more than 3 in Organoleptic assessment.
6)Subjects having score of 2 or more than 2 in assessment by Tanita.
7)Subjects having score of more than 140 ppb in Halimeter.
8)Subjects with no tooth sensitivity during screening.
9)No cervical lesions, or dental pain.
10)Subjects who agree to discontinue the use of over-the-counter breath freshness products (mouthwash, gargles, mouth spray, chewing gum, etc) throughout the trial.
11)Subjects who agree to discontinue the use of any other oral care product like mouth wash, oil pull, any medicated gargle, mouth sprays, any tooth gel or chewing gums etc. throughout the trial.
12)Subjects who consent to consume the food provided by the study site.
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 any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
3)Subjects who are Pan/Gutka eaters and smokers.
4)Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
5)Subjects have any known allergies to over-the-counter oral products.
6)Subjects have any known allergies to the trial product ingredients.
7)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
8)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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test product in terms of change in Halitosis from baseline using Halimeter.
2. To assess the effectiveness of the test product in terms of change in Halitosis/malodour from baseline using Tanita.
3. To evaluate the effectiveness of the test product in retaining freshness after 1st usage of the test product from baseline using organoleptic assessment scale by Dentist.
|
1. At Day 01 before test product usage and after test product usage at T0 plus 5 mins and T12 hours on Day 01 and on Day 28 (if applicable)
2. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable)
3. At Day 01 before test product usage and after test product usage at T0 plus 5 mins, T13 hours, and T12 hours on Day 01 and on Day 28 (if applicable) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test product in terms of change subject perception questionnaires after test product usage, using the 5-point scoring scale. |
After usage of the test product at T0 at 5mins and T12 hours on Day 01 and on Day 28 (if applicable) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2024 |
| 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="0"
Days="28" |
|
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
|
Assessment of Safety and Up to 12 hours Long-Lasting Fresh Breath Efficacy of the Test Product with Single Use in Healthy Adult Subjects with Oral Malodour: An Open-Label, Single-Arm, Single-Centre, Prospective Interventional Clinical Study. Duration will be approximately 28 days if applicable. Visit 01: Screening, ICD, Evaluation. Visit 02: Enrolment, Evaluations, End of Study. Visit 03: Evaluations End of Study (if applicable) |