| CTRI Number |
CTRI/2018/04/013267 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FMCG] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study efficacy of herbal toothpaste on oral hygiene and bad breath |
|
Scientific Title of Study
|
Effectiveness of Dabur Red Toothpaste containing herbal extracts on Gingival health and Halitosis of tobacco users |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/125/PHD/2017, Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Datta |
| Designation |
Associate Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Department of Public Health Dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Datta |
| Designation |
Associate Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Department of Public Health Dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Datta |
| Designation |
Associate Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Department of Public Health Dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited, Plot Number 22, site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot Number 22, site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Sonia Datta |
Inderprastha Dental College & Hospital |
Department of Public Health Dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH |
01204176700
pankajdatta97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Red Toothpaste |
Each 100g paste derived from: Herbal Extract 2.5% derived from:[Maricha/Marica (Piper nigrum, Fr., Powder), Pippali (Piper longum, Fr., powder), Shunthi (Zingiber officinale, Rz., Powder), Tomar (Zanthoxylum armatum, Sd., Powder)],Lavanga (Syzygium aromaticum, Fl. bud, Oil), Karpura (Cinnamomum camphora, Lf., satva), Pudina(Mentha species, Pl., satva), Gairic powder, Preservatives, Excipient-q.s.
The product is applied approximately 1.00 g twice daily for 6 weeks with a soft bristle toothbrush |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Those having sound general heath.
2. Those not having known allergy to any of the ingredient of the test product.
3. Those giving signed consent forms.
4. Those having history of tobacco use (in any form) for atleast one year duration.
5. Those at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 2 or more at baseline.
6. Those having organoleptic score 3 or greater at baseline.
|
|
| ExclusionCriteria |
| Details |
Those not fulfilling inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival index, Oral Malodor |
Baseline, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lobene Stain Index (Area),Lobene Stain Index (Intensity) |
Baseline, 3 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2017 |
| Date of Study Completion (India) |
06/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of this study may be used for publishing scientific papers and data. All the data generated on the study is exclusive property of sponsor and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was monocentric, open label, single arm efficacy study. The duration of test product application was conducted for a period of 6 weeks for each subject and included a total of 3 visits ( Baseline, 3 weeks, 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent. A total of 100 male and female subjects were enrolled in the study, out of which 38 subjects had habit of smoking tobacco only, 20 subjects had habit of both smoking and smokeless tobacco and 42 subjects had habit of smokeless tobacco only. All the subjects completed the study and no drop outs were reported. There was no side effects/ adverse event during the period of the study. The oral hygiene parameters were assessed in terms of Gingival Index, Plaque index, Lobene stain index and Oral malodor (bad breath). The test product was found to significantly improve all four parameters / conditions assessed; i.e. plaque, gingivitis, teeth stains and oral malodor at the end of 6 weeks of study period. |