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CTRI Number  CTRI/2024/03/064930 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   comparative study 
Study Design  Other 
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 pH, viscosity and matrix metalloproteinase-8 and matrix metalloproteinase-9 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  sampreethagadigi06@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  9986478744  
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  sampreethagaidi06@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 Dept of Pediatric and Preventive Dentistry No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru 560074 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 		 9740805217

sampreethagadigi06@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children of 3-6 years of age.
2.Children with 4 and more than 4 active carious lesions.
3.Children with no caries.
4.Parents giving consent for the study.  
 
ExclusionCriteria 
Details  1. Children who received fluoride topical application using the last 1 month
2. Children requiring special health care needs.
3. Pulpally involved teeth.
4. Children who were on antibiotic therapy within the past 3 months.
5. Children with genetic diseases or syndromes.
6. Children on any medications.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the pH and viscosity in the saliva of children with and without caries using
pH meter. To estimate and correlate Matrix metalloproteinase-8 and Matrix metalloproteinase-9 in
caries free and caries active children using ELISA method.  		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate and correlate Matrix metalloproteinase-8 and Matrix metalloproteinase-9 in Caries free and 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)   05/04/2024 
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="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 salivary pH, viscosity and matirxmetalloproteinase-8 and matirxmetalloproteinase-9 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 to assess salivary pH, viscosity and matirxmetalloproteinase-8 and matirxmetalloproteinase-9.

 


 
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