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CTRI Number  CTRI/2021/03/032326 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 27/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Germ kill efficacy of 5 oral hygiene products 
Scientific Title of Study   Clinical trial to evaluate the antimicrobial and antifungal efficacy of five oral hygiene products in healthy adult volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarvesh Vijay 
Designation  Consultant Dentist 
Affiliation  MS Clinical Research Pvt Ltd 
Address  327/15, 1st main road, Cambridge layout, Ulsoor, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sarvesh.rdc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vedula sasibhushan 
Designation  Senior Manager 
Affiliation  Dabur India Limited 
Address  Dabur India limited

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  01203368614  
Fax    
Email  vedula.sasibhushan@dabur.com  
 
Details of Contact Person
Public Query  
Name  Ms Ritambhara 
Designation  Executive Director 
Affiliation  MS Clinical Research Pvt Ltd 
Address  327/15, 1st main road, Cambridge layout, Ulsoor, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  ritambhara@mscr.in  
 
Source of Monetary or Material Support  
Dabur India Limited, Plot 22, Site 4, Sahibabad, Ghaziabad 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Plot 22, Site 4, Sahibabad, Ghaziabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Ms Radha  MS Clinical Research Pvt Ltd  327/15, 1st main road, Cambridhe Layout, Ulsoor, Bangalore-560008
Bangalore
KARNATAKA 		 08040917253

radha@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral hygiene 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator toothpaste  Toothpaste- Single use- one day intervention 
Intervention  Dabur Dantrakshak  Toothpaste- Single use - one day intervention 
Intervention  Dabur Red BAE gel  Toothpaste3- Single Use- One day intervention 
Intervention  Dabur Red Paste  Toothpaste- Single Use- One day intervention 
Intervention  Dabur Red Pulling OIl  Oral Rinse/ Mouthwash - Single use- One day intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate
Subjects of both genders in age group 18 – 65 years (both the ages inclusive).
Subjects willing to give their swab samples for analysis.
Subjects willing to follow 12 hr overnight gap of brushing/mouthwash and 4 hr fasting after brushing/mouthwash.
Subjects willing to come for follow up visits at the specified time.
Subjects ready to follow instructions during the study period .
Subjects using toothpastes and mouthwash other than Dabur. 
 
ExclusionCriteria 
Details  • A known history or present condition of hyper sensitivity to any toothpaste.
• The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
• Any history of periodontal therapy by surgical interventions.
• Any history of dentine hypersensitivity treatment.
• Orthodontic treatment with fixed appliances.
• Any removable device such as a removable partial denture or orthodontic retainer.
• The presence of any fixed appliance, large or defective restorations, cracked enamel,
• History of smoking or smokeless tobacco products.
• Subjects having moderate to severe dentine hypersensitivity.
• Subjects having abnormal frenum attachment.
• Subjects who are pregnant, lactating or nursing.
• Subjects having severe level of calculus and/ tartar.
• Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in germ count in percentage in comparison to baseline and control product.  Before Brushing, After brushing (Immediately, 2hr and 4 hr) 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in specific germ counts in selected groups as compared to baseline and control product.   Before Brushing, After brushing (Immediately, 2hr and 4 hr) 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   26/03/2021 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dental hygiene refers to the practice of keeping the mouth, teeth and gums clean and healthy to prevent disease. Dental hygiene and oral health are often taken for granted but are essential parts of our everyday lives.  The antimicrobial properties of ayurvedic ingredients present in toothpastes and mouthwashes help in maintaining oral hygiene. This study is to evaluate the antimicrobial efficacy of the different oral hygiene products in by assessing the total viable count and specifically s.mutans and candida albicans (two groups) as markers and beneficial effect in maintaining oral hygiene. 
The study includes Red Paste, Red BAE gel, Pulling Oil and Dant Rakshak toothpastes along with a marketed comparator product. The microbiological study will be performed on clinical isolates obtained by oral swabs at variou stime points on the same day, i.e, Before brushing, immediately after brushing, 2 hrs after brushing and 4 hrs after brushing. 
 
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