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CTRI Number  CTRI/2014/04/004519 [Registered on: 02/04/2014] Trial Registered Prospectively
Last Modified On: 19/12/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Oral Malodor and oral pathogen]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 Effect of Test Chewing Gums on bad breath and oral micro-organisms 
Scientific Title of Study   Effect of Test Chewing Gums on Oral Malodour and Oral Pathogens 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KL_ITINOM03_Version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushama R Galgali 
Designation  Principal Investigator 
Affiliation  V S Dental College & Hospital 
Address  V S Dental College & Hospital K R Road V V Puram

Bangalore
KARNATAKA
560004
India 
Phone    
Fax    
Email  shamagl@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushama R Galgali 
Designation  Principal Investigator 
Affiliation  V S Dental College & Hospital 
Address  V S Dental College & Hospital K R Road V V Puram

Bangalore
KARNATAKA
560004
India 
Phone    
Fax    
Email  shamagl@yahoo.co.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Simran Sethi 
Designation  Director- Operations, Personal Healthcare 
Affiliation  Karmic Lifesciences LLP  
Address  Karmic Lifesciences LLP Ground Floor, Unit no. 2, Reliable Plaza, Thane Belapur Road, Airoli, Navi Mumbai

Mumbai
MAHARASHTRA
400708
India 
Phone  079-66135618  
Fax    
Email  simran.sethi@karmiclifesciences.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ITC Limited 
Address  ITC Life Science and Technology Center Peenya Industrial Area, 1st Phase, Bangalore - 560058  
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
Karmic Lifesciences   802, Building No. 3, Raheja Mind Space(SEZ), Plot No. 3, TTC Industrial Area, Airoli,Navi Mumbai - 400708 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akanksha Mathur  Personal Healthcare  Karmic Lifesciences LLP Ground floor, Personal Healthcare Sigma I Corporates, Opp. Mann Party Plot, Off. S. G. Highway, Bodakdev Ahmedabad- 380054 India
Ahmadabad
GUJARAT 		 7878587334

akanksha.mathur@karmiclifesciences.com 
Dr Sushama R Galgali  V S Dental College & Hospital  2nd floor Department of Periodontics V S Dental College & Hospital K R Road V V Puram 560004 India
Bangalore
KARNATAKA 		 9845127266

shamagl@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kempegowda Institute of Medical Sciences Institutional Ethics Committee  Approved 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral Malodour 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Chewing gum  Gums must be consumed thrice a day after meals for 15 days 
Intervention  Product 1 - Chewing Gum PCG   Gums must be consumed thrice a day after meals for 15 vdays 
Intervention  Product 2 - Chewing Gum PCG  Gums must be consumed thrice a day after meals for 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Males and females, more than or equal to 18 years to less than or equal to 50 years of age
2. Halimeter reading of T-VSC (total volatile sulphur compounds) of 200 ppb (parts per billion) or more
3. Salivary levels of S. mutans more than 10,000 CFU/mL
4. Subjects with non-compromised oral health – Subjects should not have untreated caries lesions, clinical signs of gingivitis or periodontal disease, orthodontic patients, oral carcinoma, etc.
5. Subjects not undergoing antibiotic or antimicrobial therapy
6. Subjects willing to use standard toothpaste and toothbrush provided to them, throughout the study
7. Subjects willing to use a tongue cleaner provided to them, throughout the study
8. Females of child-bearing potential and males should be willing to use adequate methods of contraception
9. Must be willing and able to give informed consent and comply with the study procedures.  
 
ExclusionCriteria 
Details  1. Subjects using fixed orthodontic appliances
2. Subjects on drugs for xerostomia, e.g. pilocarpine or cevimeline
3. Subjects who are allergic to any of the ingredients of the study product
4. Subjects who have undergone long term antibiotic therapy (for 30 days or more in the past three months)
5. Subjects who are smokers or current users of narcotics
6. Subjects using commercial mouthwash, antibacterial tooth paste and dental floss
7. Subjects who are consuming probiotics products in any formats
8. Pregnant or lactating women
9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect assessed in terms of mean reduction in halimeter readings of T-VSC (total volatile sulphur compounds) between the groups   From baseline, Day 1 to Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
Mean reduction in halimeter readings of T-VSC between the groups  From baseline, Day 1 to Day 21  
Mean reduction in organoleptic measurements between the groups   From baseline, Day 1 to Day 15 and Day 21 
Reduction in counts of S. mutans between the groups   From baseline, Day 1 to Day 15 and Day 21 
Reduction in counts of C.albicans between the groups   From baseline, Day 1 to Day 15 and Day 21 
Reduction in counts of P.gingivalis between the groups   From baseline, Day 1 to Day 15 and Day 21 
Increase in salivary counts of Lactobacilli sp.   From baseline, Day 1 to Day 15 and Day 2 
Improvement in QOL affected by oral malodour   From baseline, Day 1 to Day 15 and Day 21 
Improvement in subject-satisfaction after using the investigational products.  From baseline, Day 1 to Day 15 and Day 21 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/04/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This will be a randomized, placebo-controlled, double blind study with three parallel arms. Subjects will be randomly assigned equally to one of three groups. One group will be given placebo gums and the remaining two groups will be given different sets of gums containing actives. Approximately 78 subjects will be enrolled from 1 participating center in India. The primary objective of this study will be to evaluate the effect on reduction in volatile sulphur compounds in oral cavity. 
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