| 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
|
|
|
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.
|