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CTRI Number  CTRI/2018/03/012632 [Registered on: 19/03/2018] Trial Registered Retrospectively
Last Modified On: 18/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Xylitol chewing gums on oral bacteria 
Scientific Title of Study   To evaluate the effect of use of chewing gum containing 100% xylitol on mutans streptococci salivary levels among dental students in bangalore city - a randomised controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chaithra V 
Designation  Reader 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Ground floor. Room No. 8 Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, 5/3 Hosur Road, Lakkasandra

Bangalore
KARNATAKA
Dr Shruti Ramesh
India 
Phone  9886145047  
Fax    
Email  drchaithrav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vanishree N 
Designation  Professor and Head 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Ground floor. Room No. 8 Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, 5/3 Hosur Road, Lakkasandraa

Bangalore
KARNATAKA
560027
India 
Phone  9880030208  
Fax    
Email  vansan25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vanishree N 
Designation  Professor and Head 
Affiliation  Bangalore Institute of Dental Sciences 
Address  Ground floor. Room No. 8 Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, 5/3 Hosur Road, Lakkasandraa

Bangalore
KARNATAKA
560027
India 
Phone  9880030208  
Fax    
Email  vansan25@gmail.com  
 
Source of Monetary or Material Support  
Oxford Dental College and Hospital 10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068 
 
Primary Sponsor  
Name  The Oxford Dental College and Hospital 
Address  10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
Oxford dental college  10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Chaithra V  The Oxford Dental College and Hospital  Third Floor,Room No.8, Department of Public Health Dentistry, 10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 
9886145047

drchaithrav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Review Board of The Oxford Dental College and Hospital  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  100% xylitol chewing gums EPIC (Epic Industries Inc. CA, USA)  Duration of 3 months, twice a day.Composition includes xylitol, gum base, citrus extracts, soy lecithin, gum Arabic, titanium dioxide and carnauba wax.  
Comparator Agent  Placebo chewing gum  Duration of 3 months, twice a day. Composed of gum base, gum Arabic, titanium dioxide and carnauba wax and did not have any active ingredient to be used as a control in the present study.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Subjects who did not have any active carious lesions.

Subjects who were not on any systemic antibiotic medication, 3 months prior to the commencing of the study.

Subjects available for the entire duration of the study, willing to participate were included in the study. 
 
ExclusionCriteria 
Details  Subjects who had recent exposure to topical or systemic fluoride treatment.

Subjects who were phenylketonurics.

Subjects who had a history gastro-intestinal problems.

Subjects who were habitual consumer of chewing gums.

Subjects who were undergoing any orthodontic treatment at the time of the study. 
 
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 action of 100% xylitol chewing gums at the dose and frequency used in our study in reduction of mutans streptococci and this strategy can be used as a targeted caries-preventive measure   30, 60 , 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Follow-up for measuring stretptococcus mutans count, salivary pH levels and buffering capacity  60 days and 90 days 
 
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)   01/04/2012 
Date of Study Completion (India) 30/09/2012 
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   none yet 
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 100% xylitol chewing gums on the salivary measures and oral micro flora which attribute to the caries preventive action.

The major findings of our double blind parallel arm Randomized controlled trial were that the mean age of the study subjects was 19.45+/- 1.37 years. The salivary pH in Group I had significantly increased after 30 days of intervention (5.83 to 6.62, p<0.05) as compared to the baseline but did not show a sustained effect at the follow-up at 60 and 90 days.

The salivary buffering capacity also significantly varied between the two groups after 30 days of intervention and had a sustained effect only upto 60 days follow-up period.

The results in our trial showed that there was a difference in the salivary flow rate between the two groups at 30 days of intervention (1.34 ml/minute to 2.46 ml/minute), but at the follow-up time intervals the salivary flow rate did not differ significantly between the two groups. However, Group I showed an increased salivary flow rate in the follow-up time intervals and sustained the effect till the end of our study.

There were significant reductions in salivary levels of mutans streptococci at 30 days after intervention when compared to the baseline and the effect was maintained even beyond interruption. Group I showed greater amounts of mutans streptococcus counts reduction at the end of follow-up phase when compared to Group II.

Thus our study supports the action of 100% xylitol chewing gums at the dose and frequency used in our study in reduction of mutans streptococci 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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