| CTRI Number |
CTRI/2019/08/020921 [Registered on: 27/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study with herbal toothpaste for plaque control, fresh breath and dental caries reduction |
|
Scientific Title of Study
|
Part: 1- Efficacy study of Herbal dentifrice (DABUR- B-CARE) for Dental plaque & oral malodor reduction (PI, GI, GBI indices & Oral malodor assessment): A six weeks study.
Part: 2- Efficacy study of Herbal toothpaste for preventing Dental Caries (12 months study)
|
| Trial Acronym |
DABUR BCARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/151/PHD/2019; version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital,
Department of Public Health Dentistry, Site IV Sahibabad, Ghaziabad, Uttar Pradesh, India
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9811274799 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital,
Department of Public Health Dentistry, Site IV Sahibabad, Ghaziabad, Uttar Pradesh, India
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9811274799 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital,
Department of Public Health Dentistry, Site IV Sahibabad, Ghaziabad, Uttar Pradesh, India
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9811274799 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited, Sahibabad |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot no. 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, Sahibabad |
Department of Public Health Dentistry, 3rd floor, Room no.3,Site IV, Sahibabad
Ghaziabad
UTTAR PRADESH |
9811274799
pankajdatta97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha dental college & Hospital, Sahibabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers, aged 18-60 years(both genders)with plaque induced gingivitis and caries susceptibility. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Toothpaste BCARE |
Non Fluoride Herbal toothpaste.
CaCO3, Sorbitol, glycerin, aqua, herbal extracts, Na silicate, Na lauryl sulphate, flavour.
Toothpaste applied on toothbrush used twice daily for 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Having sound general health
2. Not having any known allergy to any of the ingredients of the test product
3.Giving signed consent forms
4.Non pregnant and non lactating females. |
|
| ExclusionCriteria |
| Details |
1. Those not fulfilling inclusion criteria
2. Mouthwash or any other herbal or medicated toothpaste use in recent past
3.having untreated dental caries
4. having any orthodontic or prosthetic appliances
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction of Dental plaque, gingivitis and
gingival bleeding at 6 weeks.
2. Reduction in dental caries at 12 months. |
1. Reduction of Dental plaque, gingivitis and gingival bleeding at 6 weeks.
2. Reduction in dental caries at 12 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of safety of subjects throughout the study period |
End of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2019 |
| 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="1"
Months="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Yet to be completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present clinical study is in 2 parts on same
volunteers with the objectives of:
1.
To study the clinical
efficacy of an herbal dentifrice containing different active ingredients in
control of plaque induced gingivitis and oral malodor after twice-daily
brushing for a period of 6 weeks.
2.
To evaluate the efficacy
of an herbal dentifrice containing different active ingredients for
preventing Dental Caries (same study population); After twice- daily brushing
for a period of 12 months/ 52 weeks.
Overall assessment will be done at the end of 12
months.
|