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CTRI Number  CTRI/2017/03/008054 [Registered on: 09/03/2017] Trial Registered Retrospectively
Last Modified On: 11/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of efficacy and safety of Dabur Ayurtejas dental paste 
Scientific Title of Study   An open label, single arm, monocentric clinical study to evaluate of efficacy and safety of Dabur Ayurtejas dental paste 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh P 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road, Cambridge layout Ulsoor,Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  9060499999  
Fax  918041125934  
Email  dr.lokeshp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Gupta 
Designation  Head - Medical Affairs & Clinical Research 
Affiliation  Dabur India limited 
Address  Dabur Research & Development Centre, Dabur India Ltd, Plot No.22, Site IV, Sahibabad Ghaziabad UTTAR PRADESH

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  919910200255  
Fax  911204552645  
Email  arun.gupta@dabur.com  
 
Details of Contact Person
Public Query  
Name  Ritambhara 
Designation  DGM 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road, Cambridge layout Ulsoor,Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  919945952952  
Fax  918041125934  
Email  ritambhara@mscr.in  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre, Dabur India Ltd 22 site IV sahibabad ghaziabad  
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research and Development Centre Dabur India Limited Plot No.22 Site IV Sahibabad, Ghaziabad  
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lokesh P  MS Clinical Research Pvt. Ltd,  Oral Department,Second Floor, 327/15, 1st Main Road, Cambridge layout Ulsoor,Bangalore-560008, Karnataka, India
Bangalore
KARNATAKA 		 919060499999
918041125934
dr.lokeshp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Commiittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: K029||Dental caries, unspecified, (3) ICD-10 Condition: R196||Halitosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dabur Ayurtejas Dental Paste   Dabur Ayurtejas Dental Paste is a polyherbal mixture of 34 herbs and 1 herb-omineral ingredients will be requested to use full length brush amount (2-2.5 gm) twice daily for 12 weeks.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with age group 18-65 years in general good health.
2. Subjects with mild, moderate and severe gingivitis.
3. Subjects having ICADS score of 1 – 4 concerning dental caries. Any ICDAS score of above 4 for particular tooth/teeth will not be considered for the evaluation.
4. Subjects having extrinsic dental stains and bad oral hygiene.
5. Minimum of 20 natural uncrowned teeth (excluding 3rd molars) must be present.
6. No history of allergy to oral care consumer product specifically ingredients of tooth paste.
7. Subjects willing to give a voluntary written informed consent for photography release and agree to come for regular follow up.
8. Subjects willing to abide by and comply with the study protocol.
9. Subjects who have not participated in a similar investigation in the past four weeks.
10. Subjects who are ready to be available for the entire duration of the study.
11. Subjects who are willing not to participate in any other clinical study during participation in the current study.
 
 
ExclusionCriteria 
Details  1. A known history or present condition of hyper sensitivity to any tooth paste.
2. The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during previous 1 month.
3. Moderate to severe periodontal condition.
4. Any periodontal therapy by surgical interventions along with medications during previous 1 month.
5. Orthodontic treatment with fixed appliances.
6. The presence of any fixed appliance, large or defective restorations, cracked enamel, or caries on the history hypersensitive tooth.
7. Subjects consuming smokeless tobacco products.
8. Subjects having moderate to severe dentine hypersensitivity.
9. Subjects having intrinsic dental stains.
10. Subjects who have had any treatment which may interfere the dental evaluation.
11. Subjects having abnormal frenum attachment.
12. Significant decreased salivary flow.
13. Any uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, HIV, hepatitis, or any other serious medical illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in gingivitis in comparison to baseline.
2. Reduction of plaque in comparison to baseline.
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction of plaque, halitosis, dental staining and in improvement of overall oral hygiene in comparison to baseline.
2. Strengthening of teeth and gums.
3. Significant reduction of gum bleeding and gum pain.
4. Prevention of teeth from further aggravation of dental caries after TP usage of 3 months.
5. Control in tooth erosion after TP usage.
6. Protecting teeth from germs
7. Whitening of teeth
8. Safety for gingival, oral mucosa and lips.
 		 12 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   N/A 
Date of First Enrollment (India)   06/03/2017 
Date of Study Completion (India) 08/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Adult subjects of either sex with age between 18-65 years (both inclusive) will be screened for eligibility criteria. On screening visit a written informed consent will be obtained from the subject. Assessment of inclusion and exclusion criteria will be done including dental & systemic parameters, Subject will be trained on brushing technique and filling of subject diary. After that subject will be given 100 gm of Dabur Ayurtejas Dental Paste, a soft bristle, toothbrush and subject diary. Subject will be asked to brush two times a day (Morning & Evening). Subjects will be asked to follow up at week 2, 4, 8 & 12 (End of study). At each follow up and end of study visit, subject’s dental & general examination along with parameters as mentioned in appendix 2a will be performed. At every visit, compliance check regarding IP usages and filling of subject diary will be done. IP will be replenished at each and a new brush will be dispensed at week 4.  At the end of the study, all used and unused IP will be retrieved and study exit form will be filled up.  Adverse events will be recorded throughout the study. 
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