| CTRI Number |
CTRI/2017/10/010080 [Registered on: 12/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Salivary levels of microorganisms in Early childhood caries. |
|
Scientific Title of Study
|
Salivary levels of mutans streptococci and streptococci sanguinis in early childhood caries before and after the treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Patidar |
| Designation |
Post graduate student |
| Affiliation |
M M College of Dental Sciences and Research |
| Address |
Department of Pedodontics
Maharishi Markandeshwar College of Dental Science and Research
Maharishi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059930485 |
| Fax |
|
| Email |
drdeepika.prasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H P Suma Sogi |
| Designation |
Professor and Head |
| Affiliation |
M M College of Dental Sciences and Research |
| Address |
Department of Pedodontics
Maharishi Markandeshwar College of Dental Science and Research
Maharishi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059930475 |
| Fax |
|
| Email |
hpsumasogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Patidar |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar College of Dental Science and Research |
| Address |
Department of Pedodontics
Maharishi Markandeshwar College of dental Science and Research
Maharishi Markandeshwar University
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8059930485 |
| Fax |
|
| Email |
drdeepika.prasad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded by the researcher
Deepika Patidar
Flat No H 29
Maharishi Markandeshwar University Campus
Mullana |
|
|
Primary Sponsor
|
| Name |
M M College of Dental Science and Hospital |
| Address |
M.M College of Dental Science and Hospital
M M University
Mullana |
| Type of Sponsor |
Research institution 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 |
| Dr H P Suma Sogi |
M M College of Dental Science and Research M M University |
Department of Pediatric and Preventive Dentistry
Dental division
Room number 4
Ambala
HARYANA |
8059930475
hpsumasogi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MM University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Early childhood caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mutans streptococci and streptococci sanguinis |
salivary levels of Mutans streptococci and streptococci sanguinis before and after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1)Children between 3-6 years of age with early childhood caries .
2)Children with dmft score ≥2
3)Patients who agree to participate in the trial and sign the inform consent. |
|
| ExclusionCriteria |
| Details |
1) Children with special health care needs / any systemic illness.
2) Children taking antibiotics or completed a course of antibiotic within the last 4 weeks.
3)Children with abscess due to dental caries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Levels of microorganism before the treatment. |
Before the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Levels of microorganisms after the treatment |
Treatment duration of one month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2015 |
| Date of Study Completion (India) |
20/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Result of the study demonstrated a significant reduction in mutans streptococci count and significant elevation in streptococci sanguinis count after the dental treatment procedures |