| CTRI Number |
CTRI/2025/07/090765 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Mothers risk factor for early caries discovery in children |
|
Scientific Title of Study
|
Identification of salivary and blood biomarkers for Early childhood caries diagnosis in mother and child |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavendra Havale |
| Designation |
Head of the Department |
| Affiliation |
AME Dental College, Raichur |
| Address |
Room number 4 , Department of Pedodontics,Ame dental college, Bijangera road, Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrutha S P |
| Designation |
Professor |
| Affiliation |
AME Dental College, Raichur |
| Address |
Room number 4 , Department of Pedodontics,Ame dental college, Bijangera road, Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiny Raj R |
| Designation |
Reader |
| Affiliation |
AME Dental College, Raichur |
| Address |
Room number 4 , Department of Pedodontics,Ame dental college, Bijangera road, Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
8951799863 |
| Fax |
|
| Email |
drshinyrajmds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, Jyanagar 4th block, Bangalore, Karnataka, India- 560041 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajiv Gandhi University of Health Sciences, Jayanagar 4th block Bangalore, Karnataka, India-560041 |
| Type of Sponsor |
Other [University] |
|
|
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 Raghavendra Havale |
AME Dental College Raichur |
Department of Pedodontics, AMEs dental college Raichur, Karnataka, India-584103
Raichur
KARNATAKA |
9448407300
raghavendrahavale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for AME denatl college |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
71.00 Month(s) |
| Gender |
Both |
| Details |
Patients in the age group of 24–71 months, Patients accompanied by their mother. |
|
| ExclusionCriteria |
| Details |
medically compromised, history of congenital and genetic problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of mother and child in association with ECC |
6 months, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/08/2025 |
| 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="10"
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
|
ECC is a
widespread dental condition that affects children under six years, causing pain
and long-term oral health issues. While several factors contribute to ECC including
diet, oral hygiene, and genetic predisposition maternal influence through
biological markers remains underexplored.
This study aims to identify and correlate potential salivary and blood
biomarkers in mothers that can predict Early Childhood Caries (ECC) in their
children.
Methodology:
The project adopts a case-control study design involving 84 participants (42
mother-child pairs with ECC and 42 without ECC). The study will analyse
biomarkers such as salivary metabolites, Human Leukocyte Antigen (HLA)-DR and
DQ, Vitamin D, and iron profiles in mother-child pairs with and without ECC.
The saliva will be collected and stored in the frozen form for analysis.
Nuclear Magnetic Resonance (NMR) spectroscopy will be used to analyse the
salivary biomarkers and ELISA tests will be used to detect HLA antigens.
Laboratory iron and Vitamin D profile will be made. Statistical analyses,
including Spearman’s correlation and regression, will determine associations.
The study seeks to develop a reliable panel of
biomarkers for early detection and preventive strategies, ultimately benefiting
public health by enabling timely intervention before caries onset |