| CTRI Number |
CTRI/2025/05/086192 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To determine the salivary biomarker in children with caries active and caries free children |
|
Scientific Title of Study
|
Quantification and correlation of Salivary Tissue inhibitor matrix metalloproteinases 1 and 2 levels in caries free and caries active children A Randomized Clinical Trial |
| 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 GADIGI SAMPREETHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of Pediatric and Preventive dentistry NO.14 Ramohalli cross kumbalgodu Mysore road Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9740805217 |
| Fax |
|
| Email |
sampreethagadigi29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umapathy t |
| Designation |
PROFESSOR |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9740805217 |
| Fax |
|
| Email |
umapathygowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GADIGI SAMPREETHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of pediatric and preventive dentistry No 14 Ramohalli cross Kumbalgodu Mysore road
Bangalore
KARNATAKA
560074
India |
| Phone |
9740805217 |
| Fax |
|
| Email |
sampreethagadigi29@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari Dental College and Hospital
|
|
|
Primary Sponsor
|
| Name |
DR GADIGI SAMPREETHA |
| Address |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL
No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074 |
| Type of Sponsor |
Other [SELF FUNDED ] |
|
|
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 Gadigi Sampreetha |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Dept of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09740805217
sampreethagadigi29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children of 3-6 years of age
children with 4 and/or more active carious lesions (S-ECC)
children with no caries and parents giving consent for the study |
|
| ExclusionCriteria |
| Details |
Children who received fluoride topical application during the last month
children requiring special health care needs Pulpally involved teeth
children who were on antibiotic therapy within the past 3 months
children with genetic diseases or syndromes and children on any medications |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate and correlate tissue inhibitor Matrix metalloproteinase-1 and tissue inhibitor Matrix metalloproteinase-2 in
caries free and caries active children using ELISA method. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate & correlate tissue inhibitor matrix metalloproteinase-1 & tissue inhibitor matrix metalloproteinase-2 in caries free & caries active children |
baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/06/2025 |
| 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="6"
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
|
The present study will be done on 40 subjects to assess the correlation of Salivary Tissue inhibitor matrix metalloproteinases 1 & 2 levels in caries and caries free aged 3-6 years. 20 subjects are taken in each group. A thorough clinical examination will be done for active carious lesions using dmfs indices (>=4 active caries). An stimulated saliva will be collected. the subjects will be asked to seat comfortably with eyes open, head tilted slightly forward with restricted orofacial movements, and will be instructed to rest for 5 min. Saliva will be allowed to accumulate in the floor of the mouth and the subjects will be asked to spit into a sterile saliva collecting vial. All the samples will be transferred aseptically and sent for analysis of tissue inhibitor matrix metalloproteinase 1& 2 levels through ELISA. |