| CTRI Number |
CTRI/2024/07/071359 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Evaluation of Association of Caries with Breastfeeding and Bottlefeeding in Participants of age 1 to 6 years |
|
Scientific Title of Study
|
Evaluation of Pattern of Breastfeeding and Bottlefeeding Behaviour and Their Association with Early Childhood Caries in the age group of 1 to 6 years: An Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sannu Sonal |
| Designation |
Junior Resident |
| Affiliation |
Unit of Pediatric and Preventive Dentistry |
| Address |
Room no -9, Unit of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7522022026 |
| Fax |
|
| Email |
sannu.blueray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vinay Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Unit of Pediatric and Preventive Dentistry |
| Address |
Room no -9, Unit of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415087360 |
| Fax |
|
| Email |
dr.vinaypedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vinay Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Unit of Pediatric and Preventive Dentistry |
| Address |
Room no- 9, Unit of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415087360 |
| Fax |
|
| Email |
dr.vinaypedo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sannu Sonal |
| Address |
Unit Of Pedodontics, Faculty of Dental Sciences, BHU, Varanasi, Uttar Pradesh, India 221005 |
| 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 Sannu Sonal |
Faculty of Dental Sciences, BHU |
Room no.9, Unit of Pedodontics, Faculty of Dental Sciences, BHU, Varanasi
Varanasi
UTTAR PRADESH |
7522022026
sannu.blueray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, IMS, BHU, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children between age group of 1- 6 years with primary dentition |
|
| ExclusionCriteria |
| Details |
1. Children below 1 year of age and above 6 years of age are not included.
2. Children with any Congenital, Hereditary or Systemic diseases are not included in this study.
3. Children’s with mixed dentition are not included.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating breast feeding and bottle feeding behaviour and its association with early childhood caries |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlating the breastfeeding and bottle feeding pattern in children with early childhood caries |
at baseline: 1 year |
|
|
Target Sample Size
|
Total Sample Size="383"
Sample Size from India="383"
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)
|
12/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental Caries is the most prevalent non communicable disease. Early Childhood Caries is common among the children in the age group of 1-6 years. The duration, frequency and pattern of breastfeeding and bottlefeeding among children plays important role in the occurence of early childhood caries. Most studies stated that the prolonged breastfeeding and night time bottle feeding have more impact in its occurence. Thus, this study aims to evaluate the association between pattern of breast feeding and bottle feeding with early childhood caries among the age group of 1-6 years. |