| CTRI Number |
CTRI/2018/08/015253 [Registered on: 09/08/2018] Trial Registered Prospectively |
| Last Modified On: |
08/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study in Adult Smokers |
|
Scientific Title of Study
|
A Prospective, Open-Label, Non-Randomized, Single-Arm, Efficacy and Safety Outcome Clinical Study using “Dabur Herb’l Smokers Natural Tooth Paste†in Adult Smokers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 18/CCR/DI/SETP/02 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagalakshmi AnandaPadmanabhan |
| Designation |
CEO |
| Affiliation |
Consortium Clinical Research Pvt. Ltd. |
| Address |
Consortium Clinical Research Pvt. Ltd.,9 / 41, Sri Kalki GardensKuniyamuthur Post, Coimbatore
Coimbatore
TAMIL NADU
641 008
India |
| Phone |
9789777777 |
| Fax |
|
| Email |
naga@consortiumcr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nagalakshmi AnandaPadmanabhan |
| Designation |
CEO |
| Affiliation |
Consortium Clinical Research Pvt. Ltd. |
| Address |
Consortium Clinical Research Pvt. Ltd.,9 / 41, Sri Kalki GardensKuniyamuthur Post, Coimbatore
Coimbatore
TAMIL NADU
641 008
India |
| Phone |
9789777777 |
| Fax |
|
| Email |
naga@consortiumcr.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagalakshmi AnandaPadmanabhan |
| Designation |
CEO |
| Affiliation |
Consortium Clinical Research Pvt. Ltd. |
| Address |
Consortium Clinical Research Pvt. Ltd.,9 / 41, Sri Kalki GardensKuniyamuthur Post, Coimbatore
Coimbatore
TAMIL NADU
641 008
India |
| Phone |
9789777777 |
| Fax |
|
| Email |
naga@consortiumcr.com |
|
|
Source of Monetary or Material Support
|
| Dabur International Limited
P.O. Box: 16944,
Near JAFZA Gate 4,
Jebel Ali Free zone,
Dubai, UAE
|
|
|
Primary Sponsor
|
| Name |
Dabur International Limited |
| Address |
P.O. Box: 16944,
Near JAFZA Gate 4,
Jebel Ali Free zone,
Dubai, UAE
|
| Type of Sponsor |
Other [Marketing] |
|
|
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 Jagathesan Shanmugavel |
NG Hospital |
T – 20, Kovaipudur,
Coimbatore – 641 042
Tamilnadu
Coimbatore
TAMIL NADU |
6362241525
shailaja@consortiumcr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - NG Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smokers with stained teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Herb’l Smokers Natural Tooth Paste |
Twice daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either genders
2. Subjects between age of 18 and 55 (inclusive) years
3. Subjects who are medically/systemically fit
4. Non pregnant females
5. Non-lactating females
6. No history of allergy to oral care consumer products - specifically ingredients of tooth paste
7. Subjects should be a regular user of tooth paste and a tooth brush
8. Subjects willing to give a voluntary written informed consent
9. Subjects must be Smoking on a daily basis with stained teeth
|
|
| ExclusionCriteria |
| Details |
1. Subjects who use mouth washes regularly
2. Subjects with a known history or present condition of hyper sensitivity/allergy to any tooth paste, mouthwash or oral hygiene products
3. Subjects who have used any antibiotic, antimicrobial, analgesic medications, or desensitizing tooth paste during previous 1 month
4. Subjects with partial removable dentures, orthodontic bands, or advanced periodontal disease
5. Subjects with inadequate restorations or untreated dental carries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in stained colour of teeth |
End of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Safety |
End of 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/08/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/11/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objectives of this study are to
evaluate the clinical efficacy of “Dabur Herb’l Smokers Tooth Paste†by an
overall change in the microbial colonies causing fresher breath and decrease in
the hard yellow stains of the teeth leading to extreme whitening; and assessing
any Investigational Product related adverse events.
|