| CTRI Number |
CTRI/2026/02/103375 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Evaluate Immune Responses in Children with Early Childhood Caries Using Molecular Analysis |
|
Scientific Title of Study
|
Molecular Characterization of Innate and Adaptive Immune Responses in Children with Early Childhood Caries - An in vitro Clinico-Immunological Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niveditha R |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28 , Department of Pediatric and Preventive Dentisty , Saveetha Dental College and Hospitals , 162 Poonamallee High Rd, Velappanchavadi , Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840770137 |
| Fax |
|
| Email |
rengarajanniveditha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh R |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28 , Department of Pediatric and Preventive Dentisty , Saveetha Dental College and Hospitals , 162 Poonamallee High Rd, Velappanchavadi , Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh R |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28 , Department of Pediatric and Preventive Dentisty , Saveetha Dental College and Hospitals , 162 Poonamallee High Rd, Velappanchavadi , Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals,162, Poonamallee High Rd , Velappanchavadi, Chennai Thiruvallur TAMIL NADU 600077 India |
|
|
Primary Sponsor
|
| Name |
Niveditha R |
| Address |
Clinic - 28 , Department of Pediatric and Preventive Dentistry , Saveetha Dental College and Hospitals ,162, Poonamallee High Rd , Velappanchavadi, Chennai, Tamil Nadu-600077 |
| 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 Niveditha R |
Saveetha Dental College and Hospitals |
Clinic 28 , 5th floor , Dept of Pediatric and Preventive Dentistry, 162 Poonamallee High Rd Velappanchavadi
Chennai
TAMIL NADU |
09840770137
rengarajanniveditha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with Early Childhood caries, or ECC with dental abscesses based on clinical and radiographic examination
Caries free, age matched healthy children serving as controls
Children whose parents/guardians provide informed written consent
Children who are systemically healthy at the time of enrollment |
|
| ExclusionCriteria |
| Details |
Children with systemic diseases,immunological disorders , or hematological abnormalities.
Children on antibiotic , anti-inflammatory, or immunosuppressive therapy within the preceding 4 weeks
Children with acute systemic infections at the time of sample collection
Children with a history of bleeding disorders or on medication affecting coagulation
Childrens whose parents/guardians do not consent to participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of immunological and hematological profiles, including PCR-based expression of innate and adaptive immune markers, among children with early childhood caries, early childhood caries with abscess, and caries-free healthy controls at baseline |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparsion of demographic and clinical parameters among the study groups.
Assessment of associated clinical signs and symptoms in children with early childhood caries and early childhood caries with abscess.
Immunohistochemical expression patterns of selected immune markers at baseline. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
16/02/2026 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to characterize innate and adaptive immune responses in children with early childhood caries and early childhood caries with abscess in comparison with caries-free healthy children. Peripheral venous blood samples will be collected to evaluate immunological and hematological profiles along with molecular assessment of immune marker expression using PCR. Immunohistochemical analysis and in-silico molecular docking will be performed to further explore immune-related pathways. Demographic and clinical parameters will also be recorded. The findings of this clinico-immunological study are expected to provide insights into host immune responses associated with early childhood caries |