| CTRI Number |
CTRI/2021/03/031689 [Registered on: 03/03/2021] Trial Registered Prospectively |
| Last Modified On: |
02/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysing the role of Preventive Dental Program in Oral Health condition of Mother-child pairs |
|
Scientific Title of Study
|
Determination of the role of Preventive Dental Program in Oral Health status of Mother-child pairs: A cohort study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vabool Thakur |
| Designation |
PG Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of dental studies and technologies, Department of pedodontics and preventive dentistry, Room No. -5 , near Kadrabad check post,Delhi Meerut road , NH- 58
Kadrabad, Modinagar, Ghaziabad
UTTAR PRADESH
201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9634855385 |
| Fax |
|
| Email |
vabool.thakur11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Agarwal |
| Designation |
Professor and Head of the department |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of dental studies and technologies, Department of pedodontics and preventive dentistry, Room No. -5 , near Kadrabad check post,Delhi Meerut road , NH- 58
Kadrabad, Modinagar, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871262302 |
| Fax |
|
| Email |
doc.nagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Agarwal |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of dental studies and technologies, Department of pedodontics and preventive dentistry, Room No. -5 , near Kadrabad check post,Delhi Meerut road , NH- 58
Kadrabad, Modinagar, Ghaziabad
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871262302 |
| Fax |
|
| Email |
doc.nagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES, DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NO.-5, DELHI-MEERUT ROAD, NH-58 KADRABAD, MODINAGAR, Ghaziabad, 201201 |
| 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 |
| Dr Nidhi Agarwal |
IDST Mayo hospital. |
IDST MAYO HOSPITAL, DEPARTMENT OF GYNAECOLOGY AND OBSTETRICS, ROOM NO. - 1 , GROUND FLOOR, NH-58 Delhi Meerut Road, Kadrabad,Modinagar, GHAZIABAD 201201
Ghaziabad
UTTAR PRADESH |
9871262302
doc.nagarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening and Preventive interventions |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Healthy ladies in their third trimester of pregnancy
Healthy infants having at least one primary tooth erupted
|
|
| ExclusionCriteria |
| Details |
Medically compromised women and infants
Pregnant women who require dental treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing the effect of preventive dental programme,
Assessment of S.mutans count |
1. At baseline
2. on the eruption of infants first tooth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the oral health status and S mutans levels of infants at the time of first primary tooth eruption,
To correlate the oral health status and S. mutans levels of the mother with the child |
Day 1 to 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/03/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted on expectant mothers in the third trimester of their pregnancy and their oral health status will be recorded. Oral S. mutans levels will be detected at baseline. All the subjects will be given preventive dental care and training regarding their own oral care. Information will be given about how to maintain infants oral health. Re-examination of mothers will be done and S.mutans levels will be recorded again after the eruption of first primary tooth of the infant. Along with that infants S. mutans levels will be evaluated at that time. The OHI-S status and S.mutans levels of the mothers and infants will be correlated. |