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CTRI Number  CTRI/2020/07/026522 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 14/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study of MNDV toothpaste in Dental Care  
Scientific Title of Study   An Open Label, Single Arm, Clinical Study to Evaluate Efficacy and Safety of MNDV toothpaste in Dental Care of Healthy Adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/20-21/006 Ver 1.0, dated 15 Feb 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ninad Naik 
Designation  Consultant 
Affiliation  Atharv Ayurved and Research Centre 
Address  Shirode Rd, opp. krishna chowk, kirti nagar, New sanghavi, pimpri chinchwad.

Pune
MAHARASHTRA
411027
India 
Phone  9422089260  
Fax    
Email  doctorninaad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Dipika Patil 
Designation  Manager 
Affiliation  Mprex Healthcare 
Address  414, Nisarg Plaza, Bhumkar Nagar, Wakad, Pune 41105

Pune
MAHARASHTRA
411057
India 
Phone  7709307004  
Fax    
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Mr Ashish Nagaonkar 
Designation  Partner 
Affiliation  M.N.Pharmaceuticals 
Address  27,Madhumansion,Old P.B.Road,NIPANI 591237. Belgaum

Belgaum
KARNATAKA
591237
India 
Phone  7892647421  
Fax    
Email  pharmaceuticals.m.n@gmail.com  
 
Source of Monetary or Material Support  
MN Pharmaceuticals 
 
Primary Sponsor  
Name  MN Pharmaceuticals 
Address  R. S.NO 51/1B, KLE CBSE CORNER BUDALMUKH ROAD, NIPANI 
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 
Dr Ninad Naik  Atharv Ayurved and Research Centre  Shirode Rd, opp. krishna chowk, kirti nagar, new sanghavi, pimpri-chinchwad
Pune
MAHARASHTRA 		 9422089260

doctorninaad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Medical Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MNDV toothpaste  4 weeks clinical study to evaluate the efficacy and safety of Herbs & More Herbal Dental Paste in dental care of healthy adults 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Age: 18 to 55 years (both inclusive) at the time of consent.
Sex: Healthy male or non-pregnant/non-lactating females.
Females of Childbearing potential must have a negative urine pregnancy test performed on screening and enrollment visit.
Subjects are in good general health as determined by the Investigator on the basis of medical history.
Subjects having T-VSC reading (total volatile sulphur compounds) of >160 ppb (parts per billion)
Subjects with mild, moderate and severe plaque with plaque index 2-4.
Subjects with mild to moderate gingivitis with modified gingival index 0.1-0.3.
Subjects should be willing to come to the test site without brushing their teeth in the morning.
Subjects should be willing to not to consume anything except water after meal of previous night.
Subjects must be able to understand and provide written informed consent to participate in the study.
Subjects should be willing and able to follow the study directions to participate in the study.
 
 
ExclusionCriteria 
Details  Subjects with orthodontic bands.
Subjects with plaque index of 0, 1 and 5
Subjects with partial removable dentures.
Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
Subjects having carious lesion which requires immediate restorative treatment.
Subjects having used antibiotics anytime during the last three months prior to entry into the study.
Subjects having participated in any other dental clinical study within last six months prior to entry into the study.
Subjects with dental prophylaxis during the past two weeks prior to baseline examinations.
Subjects with history of allergies to any oral care/personal care consumer products or their ingredients.
Subjects on any prescription medicines that might interfere with the study outcome.
Subjects taking oral contraceptives and other medication based contraceptives.
Pregnant female subjects or female planning to get pregnant during study duration.
Consumption of any medicated sweets, chewing gum, breath fresheners etc. containing antimicrobial agents.
Subjects with diseases or having history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.)
Subjects that consume alcohol.
Subjects that smoke cigarette or consume any other form of tobacco.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of test product for reduction in gingivitis (inflammation of gums) & to evaluate gum tightening by dental examination using modified gingival index.  From baseline to end of study ie day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of test product on malodor control using Halimeter.
To evaluate the effect of test product for plaque reduction using plaque index
To evaluate the effect of test product for reduction in gingival bleeding using modified sulcular bleeding index.
To evaluate the effect of test product on carious teeth by visual assessment by dentist.
To evaluate test product efficacy and tolerance via questionnaires as stated in Appendix III & IV.
 		 screening visit (Within -30 Days prior to Day 1) and enrollment (Day 1), evaluation (Day 15 ± 2days) and evaluation/end of study (Day 30 ± 2days) 
 
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 1 
Date of First Enrollment (India)   13/07/2020 
Date of Study Completion (India) 15/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Consideration of oral hygiene and the importance of Ayurveda for dental care is time tested. This research is an attempt to evaluate safety and efficacy of dental paste developed by MN pharmaceuticals in dental health. 
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