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CTRI Number  CTRI/2018/03/012793 [Registered on: 23/03/2018] Trial Registered Retrospectively
Last Modified On: 17/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of CPP -ACP Chewing gums 
Scientific Title of Study   To Assess The Effectiveness Of Sugar Free Chewing Gum With CPP-ACP On Streptococcus mutans Count" – A Double Blind Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vignesh D 
Designation  Post Graduate student 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Room no 8, Ground floor, Bangalore Institute of Dental sciences, No 5/3, Hosur main road, Lakkasandra, Bangalore

Bangalore
KARNATAKA
560027
India 
Phone  9538415527  
Fax    
Email  dr.vigumedico@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanishree N 
Designation  Professor & Head 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Room no 8, Ground floor, Bangalore Institute of Dental sciences, No 5/3, Hosur main road, Lakkasandra, Bangalore

Bangalore
KARNATAKA
560027
India 
Phone  9880030208  
Fax    
Email  vansan25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vanishree N 
Designation  Professor & Head 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Room no 8, Ground floor, Bangalore Institute of Dental sciences, No 5/3, Hosur main road, Lakkasandra, Bangalore

Bangalore
KARNATAKA
560027
India 
Phone  9880030208  
Fax    
Email  vansan25@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Institute of Dental Sciences, No 5/3, Hosur main road, Lakkasandra, Bangalore 560027 
 
Primary Sponsor  
Name  Dr Vignesh D 
Address  Room no 8, Ground floor, Bangalore Institute of Dental Sciences, No 5/3, Hosur main road, lakkasandra, Bangalore 560027  
Type of Sponsor  Other [] 
 
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 Vignesh D  Bangalore Institute of Dental Sciences  Room no 8, Ground floor, No 5/3, Hosur main road, Lakkasandra, Bangalore 560027
Bangalore
KARNATAKA 		 9538415527

dr.vigumedico@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Review Board of Bangalore Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CPP - ACP Chewing gum  The composition of this Trident white Wintergreen CPP-ACP chewing gum included : Sorbitol, Gum Base, Maltitol, Mannitol, Artificial and Natural Flavoring; Less Than 2% of Acacia, Acesulfame Potassium, Aspartame(To Maintain Freshness), Calcium Casein Peptone-Calcium Phosphate (Lactose- Free Milk Derivative), Candelilla Wax, Glycerin, Sodium Stearate, Soy Lecithin and Titanium Dioxide (Color) 
Comparator Agent  Placebo  The composition of this Trident white Peppermint chewing gum included Sorbitol, Gum Base, Maltitol, Mannitol, Artificial and Natural Flavoring; Less Than 2% of Acacia, Acesulfame Potassium, Aspartame(To Maintain Freshness), Candelilla Wax, Glycerin, Sodium Stearate, Soy Lecithin and Titanium Dioxide (Color). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Undergraduate 1st and 2nd year dental students of the institution.

Study subjects who are willing to participate and give consent.

No report of use of antibiotics 3 months prior to the beginning of the study.

Absence of active dental caries and periodontitis. 
 
ExclusionCriteria 
Details  Study subjects who were medically compromised or under any kind of
medications.

Study subjects undergoing orthodontic treatment.

Study subjects who are phenylketonurics.

Study subjects with a history of gastro intestinal problems.

Study subjects who are habitual chewing gum users. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The use of CPP - ACP chewing gums 2pellets/2 times/day leads to
increased reductions in salivary levels of Streptococcus mutans even for short periods
of 30 days and the effect was maintained even beyond interruption. 		 The use of CPP - ACP chewing gums 2pellets/2 times/day leads to
increased reductions in salivary levels of Streptococcus mutans even for short periods
of 30 days and the effect was maintained even beyond interruption. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/04/2016 
Date of Study Completion (India) 30/06/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This research marks a new beginning to the evaluation of the effectiveness of CPP – ACP chewing gums on oral micro flora which attribute to the caries preventive action. The major findings of our double blind parallel arm Randomized clinical trial were that the age of the study subjects was 18 - 25 years. The mean age of the participants was 21.12 years (standard deviation of 1.75). Gender distribution was equal in both the groups, Group A [males n=4(6.6%); females n=26(43.35%)] and Group B [males n=4(6.6%); females n=26(43.35%)]. There were significant reductions in salivary levels of Streptococcus mutans at 30 days after intervention when compared to the baseline and the effect was maintained even beyond interruption. Group B showed greater amounts of Streptococcus mutans counts reduction at the end of follow-up phase when compared to Group A. Thus our study supports the action of CPP - ACP chewing gums at the dose and frequency used in our study in reduction of Streptococcus mutans and this strategy can be used as a targeted caries preventive measure after the evaluation of its cost-effectiveness through various preventive programs.
 
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