| CTRI Number |
CTRI/2018/03/012817 [Registered on: 23/03/2018] 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 in improving oral hygiene and bad breath |
|
Scientific Title of Study
|
To Study Clinical Efficacy of an Herbal Dentifrice in control of Plaque Induced Gingivitis and Oral Malodor |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/97/PHD/2016, 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, 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 |
Inderprastha Dental College & Hospital, Department of Public health dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
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 |
Inderprastha Dental College & Hospital, Department of Public health dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
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 |
Ayurvedic Medicated Toothpaste |
Herbal Extracts derived from:[Maricha/Marica (Piper nigrum, Fr., Powder), Pippali (Piper longum, Fr., powder), Shunthi (Zingiber officinale, Rz., Powder), Tejovati/Tomar (Zanthoxylum armatum, Sd., Powder)],
Karpoor (Cinnamomum camphora, Lf., satva,
Pudina Satva (Mentha species, Pl., satva),
Lavang/Laung Oil (Syzygium aromaticum, Fl. bud, Oil),
Preservatives,
Color: Mica & CI 45430, CI 16255, Excipient (Gel Base)-q.s. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All participants had at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 1.50 or more at baseline.
2. All participants had a bad breath score of 2.0 or more at baseline.
3. All participants had a Gingival Bleeding Index score of 3.0 or more at baseline.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having history of known sensitivity or oral mucosal tissue reaction to test toothpaste.
2. Subjects undergoing antibiotic or antiinflammatory therapy or had undergone such therapy in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ayurvedic Medicated Toothpaste reduces plaque, gingivitis, gingival bleeding and bad breath |
Baseline, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall freshness and safety of the subjects throughout the study period |
Baseline, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2016 |
| Date of Study Completion (India) |
20/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="6" |
|
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, single arm efficacy study. The study 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 40 male and female subjects were enrolled in the study. 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, Gingival Bleeding Index and Oral malodor (bad breath). Results: The test product was found to significantly reduce plaque, gingivitis and gingival bleeding scores at the end of 6 weeks of study period. The test product was found to significantly reduce bad breath, 12 hours after brushing teeth after twice daily brushing for a period of 6 weeks. Majority of the subjects (80%) reported to experience fresh breath that lasts from few hours to day long. Maximum subjects (97.5%) reported to experience deep mouth clean along with fresh breath. |