| CTRI Number |
CTRI/2017/05/008518 [Registered on: 09/05/2017] Trial Registered Prospectively |
| Last Modified On: |
09/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate whether chewing gums containing useful bacteria reduce the number of cavity causing bacteria in mouth more than existing commercially available chewing gums or not. |
|
Scientific Title of Study
|
A comparative evaluation of the effect of chewing gums containing Probiotic bacteria and xylitol on salivary streptococcus mutans counts in children- a randomized 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 |
Kanwardeep kaur |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095279595 |
| Fax |
|
| Email |
kanwardeep.kaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridhar N |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences
Manipal
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886932642 |
| Fax |
|
| Email |
drsri.pedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanwardeep Kaur |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Dental Sciences Manipal |
| Address |
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095279595 |
| Fax |
|
| Email |
kanwardeep.kaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material Source
Sebastian Nummelin
Key Account Manager
Asia Pacific
BioGaia Japan Inc 4-18-12
Takanawa Minato ku
Tokyo
1080074
Japan |
|
|
Primary Sponsor
|
| Name |
Kanwardeep Kaur |
| Address |
Postgraduate Student
Department of Pedodontics and Preventive dentistry
Manipal College of Dental Sciences
Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kanwardeep Kaur |
Manipal College of Dental Sciences |
Room no 6
Department of Pedodontics and Preventive Dentistry
Manipal College of Dental Sciences
Manipal
Udupi
KARNATAKA |
8095279595
kanwardeep.kaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Kasturba Hospital Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental Caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Orbit Chewing Gum |
Orbit which is a commercially available chewing gum will be given to 16 subjects for a period of 21 days, 3 times a day after major meals and streptococcus mutans counts will be evaluated before and after the intervention. plaque and gingival scores shall also be checked |
| Intervention |
Probiotic Chewing Gums by Biogaia Sweden |
16 randomly allocated subjects shall be given probiotic chewing gums for a period of 21 days, 3 times a day after major meals and streptococcus mutans counts will be evaluated before and after the intervention. plaque and gingival scores shall also be checked. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age group of 7-12 years
2.Children with DMFT/deft score more than 1
3. Children with similar oral hygiene and dietary habits
4. Minimal or no crowding
|
|
| ExclusionCriteria |
| Details |
1 Children suffering from any long-term medical conditions
2 Children under current anti-microbial therapy or have been on the same one month prior to commencement of study.
3 Children with milk related allergies
4 Children who have large fillings/open carious lesions on the smooth surfaces of teeth
5 Children with severely crowded dentition
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Streptococcus Mutans Counts and Plaque and Gingival Scores
|
0 days and 21 days after intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Score and Gingival Score |
0 days and 21 days after intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is a part of partial fulfilment of degree of masters in pediatric and preventive dentistry. It aims to compare the effectiveness of probiotic chewing gums in children as compared to the existing xylitol chewing gums. Samples have been obtained and media has been arranged for the study. Subjects are being screened and shall be recruited thereafter following scrutinisation and randomisation.
|