| CTRI Number |
CTRI/2025/07/090781 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Analysis of Immune Markers in Young Children with Tooth Decay Caused by Streptococcus mutans |
|
Scientific Title of Study
|
Assessment of MCM2–7 and Pro-inflammatory Cytokine Expression in the Host Immune Response to Streptococcus mutans in Early Childhood Caries: An In Vivo 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 |
Somya Seth |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7597698819 |
| Fax |
|
| Email |
sdc.ssomya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh R |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh R |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
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, Tamil Nadu ,India
Pin code- 600077 |
|
|
Primary Sponsor
|
| Name |
Somya Seth |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India
Pin code- 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 Somya Seth |
Saveetha Dental College And Hospitals |
Clinic-28,Department of Pediatric and Preventive Dentistry 162, Poonamallee High Rd, Velappanchavadi
Thiruvallur
TAMIL NADU
Thiruvallur
TAMIL NADU |
7597698819
sdc.ssomya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospital Institutional Ethics Committee |
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 |
Group1 and Group2
Group1-ECC with Abscess and Swelling
Group2-ECC |
Venous blood samples will be collected from participating children at the time of their dental treatment. The collected blood will be allowed to clot and then centrifuged to separate the serum. The serum samples will be stored under appropriate refrigerated or frozen conditions until analysis. The expression levels of minichromosome maintenance proteins MCM2 to MCM7 and the pro-inflammatory cytokines tumor necrosis factor alpha, interleukin six, and interleukin one beta will be evaluated using quantitative real-time polymerase chain reaction. |
| Comparator Agent |
Group3
Group3-ECC with Dental Caries and No Pulpal Involvement |
Venous blood samples will be collected from participating children at the time of their dental treatment. The collected blood will be allowed to clot and then centrifuged to separate the serum. The serum samples will be stored under appropriate refrigerated or frozen conditions until analysis. The expression levels of minichromosome maintenance proteins MCM2 to MCM7 and the pro-inflammatory cytokines tumor necrosis factor alpha, interleukin six, and interleukin one beta will be evaluated using quantitative real-time polymerase chain reaction. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 3–5 years.
2.Children who are systemically healthy.
3.Children classified into one of the following groups:
Group 1: Children with Early Childhood Caries (ECC) presenting with clinical swelling or signs of dental abscess requiring pulpectomy.
Group 2: Children with ECC without clinical swelling, requiring pulpectomy.
Group 3: ECC with Dental Caries and No Pulpal Involvement
4.Parents or guardians willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Children with any systemic diseases or immunocompromised status.
2.Children who have received antibiotics or anti-inflammatory medication within the past 2 weeks.
3.Children with chronic medical conditions (e.g., asthma, diabetes, congenital heart disease).
4.Children with developmental dental anomalies that may affect immune or pulp response.
5.Children whose parents/guardians refuse consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the role of immunity in early childhood caries by comparing the expression levels of MCM2–7 and pro-inflammatory cytokines (tumor necrosis factor alpha, interleukin six, and interleukin one beta) in serum samples of children with ECC with swelling, ECC without swelling, and healthy control. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between the expression levels of MCM2–7 and pro-inflammatory cytokines with the clinical severity of Early Childhood Caries and the presence of swelling. |
Single Time-point |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
26/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 assess the expression of Minichromosome Maintenance Protein 2,7 and pro inflammatory cytokines (TNF alpha, IL 6, IL 1beta) in children aged 3-5 years. The study will include three groups. Group1 children with ECC with clinical swelling Group2 children with ECC without swelling Group3 children with dental caries without pulp tissue involvement The expression levels of the selected markers will be evaluated to understand the host immune response and molecular changes associated with Streptococcus mutans-induced ECC.
Study Hypothesis The expression levels of Minichromosome Maintenance Protein 2,7 and pro-inflammatory cytokines (TNF alpha, IL 6, IL 1beta) will be significantly higher in children with ECC, particularly those with clinical swelling, compared to children with caries without pulp involvement. |