| CTRI Number |
CTRI/2019/09/021205 [Registered on: 12/09/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Topical effect of Probiotic formulation on Streptococcus mutans counts in children |
|
Scientific Title of Study
|
Evaluation of topical effect of Probiotic formulation on Streptococcus mutans count in plaque in 7-12 year old children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJU PATIL |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
STESs Sinhgad Dental College and Hospital |
| Address |
Dr Raju Umaji Patil MDS CCFMJ
Professor and Head Dept of Pediatric and Preventive dentistry
STESs Sinhgad Dental College Hospital Sno 44 Vadgaon Bk Off Sinhgad road PUNE rupat13@yahoo.com
S no 44/1 Vadgaon Bk
Off Sinhgad road
Pune
MAHARASHTRA
411041
India |
| Phone |
8871963896 |
| Fax |
02024351303 |
| Email |
rupat13@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJU PATIL |
| Designation |
professor and HOD |
| Affiliation |
STESs Sinhgad Dental College and Hospital |
| Address |
Dr Raju Umaji Patil MDS CCFMJ
Professor and Head Dept of Pediatric and Preventive dentistry
STESs Sinhgad Dental College Hospital Sno 44 Vadgaon Bk Off Sinhgad road PUNE rupat13@yahoo.com
S no 44 Vadgaon Bk
Off Sinhgad road
Pune
MAHARASHTRA
411041
India |
| Phone |
8871963896 |
| Fax |
02024351303 |
| Email |
rupat13@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJU PATIL |
| Designation |
Professor and HOD |
| Affiliation |
STESs Sinhgad Dental College and Hospital |
| Address |
Dr Raju Umaji Patil MDS CCFMJ
Professor and Head Dept of Pediatric and Preventive dentistry
STESs Sinhgad Dental College Hospital Sno 44 Vadgaon Bk Off Sinhgad road PUNE rupat13@yahoo.com
S no 44 Vadgaon Bk
Off Sinhgad road
Pune
MAHARASHTRA
411041
India |
| Phone |
8871963896 |
| Fax |
02024351303 |
| Email |
rupat13@yahoo.com |
|
|
Source of Monetary or Material Support
|
| OPD patients of Pediatric and preventive dentistry dept. of STES Sinhgad dental college and hospital, Vadgaon Bk, PUNE-411041, Maharashtra |
|
|
Primary Sponsor
|
| Name |
STES Sinhgad dental college and hospital |
| Address |
S no. 44/1 Vadgaon Bk, PUNE-411041 Maharashtra |
| Type of Sponsor |
Other [Private Dental college and Hospital] |
|
|
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 |
| RAJU PATIL |
STES’s Sinhgad Dental College & Hospital |
Dept of Pediatric and Preventive dentistry, S.no.44/1 Vadgaon Bk, Off Sinhgad road,
PUNE-411041
Pune
MAHARASHTRA |
8871963896
02024351303
rupat13@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| STES’s Sinhgad Dental College & Hospital, Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
7-12 years old Children with dmft/DMFT score 2-5 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Proboitics solution |
A randomized control trial will be done on 7-12 years medium risk 10 children with dmft/DMFT score 2-5, where an innovative probiotic formulation (prepared from capsule) will be applied for 6 consecutive days and pre/post plaque samples will be evaluated for S. mutans count on mitis salivarius agar. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Children with dmft/DMFT score 2-5 |
|
| ExclusionCriteria |
| Details |
Free from systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque Streptococcus mutans counts of children |
post 6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Dental caries |
2 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/09/2019 |
| Date of Study Completion (India) |
07/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
sent for publication, under review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Probiotics compete with tooth decay causing bacteria for carbohydrate resulting in substrate depletion, hence short term topical application of probiotics on teeth can replace cariogenic bacteria, Streptococcus mutans, resulting in reduced caries activity. In this RCT on 10 children of 7-12 yrs age, topical probiotic application for 6 days showed >90% reduction in S.mutans count of oral plaque. Hence probiotic can be used as topical agent for caries prevention in children. |