| CTRI Number |
CTRI/2018/05/014135 [Registered on: 25/05/2018] 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 any bad effect of herbal toothpaste along with its efficacy on improving oral hygiene of school going children |
|
Scientific Title of Study
|
Evaluation of Adverse reactions to Dabur Red Toothpaste containing herbal extracts; and its effectiveness on Oral health status of school children in 10-11 years age group |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/126/PHD/2017, 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 |
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 |
Principal Investigator |
| 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 |
Principal Investigator |
| 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 |
Department of Public Health Dentistry, Inderprastha Dental College & Hospital |
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 |
| Healthy Human Volunteers |
Healthy Children |
|
|
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. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
11.00 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 atleast 20 teeth (of mixed dentition).
|
|
| 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 |
| Dental caries, periodontal status |
Baseline,2 weeks, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Erythema, Edema, Pain, Irritation, Burning Sensation |
Baseline,2 weeks, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 will be monocentric, open label, prospective, single arm efficacy and safety study. The duration of test product application will be conducted for a period of 12 months twice daily brushing on school children of 10-11 years age (both inclusive) and includes a total of 4 visits ( Baseline, 14 days, 6 months, 12 months). The subjects who satisfy inclusion/exclusion criteria will be enrolled after obtaining informed consent. A total of 200 male and female school children will be enrolled in the study. The study period will involve assessment of adverse reactions of Dabur Red Toothpaste among school children, effectiveness of Dabur Red Toothpaste on Oral health status of school children and efficacy of Dabur Red Toothpaste for preventing Dental caries in school children. |