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CTRI Number  CTRI/2024/08/071874 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation and correlation of human salivary biomarker levels before and after application of topical fluoride agents in children with early childhood caries 
Scientific Title of Study   Evaluation and correlation of salivary matrix metalloproteinase 8 levels before and after application of MI varnish 38 percent silver diamine fluoride and nano silver fluoride in children with 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  Dr Ganavi G Nayak 
Designation  Post graduate student 
Affiliation  Rajarajeswari dental college and hospital bengaluru 
Address  Department of pediatric and preventive dentistry Rajarajeswari dental college and hospital NO 14 ramohalli cross, mysore road,bengaluru, karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  7624908255  
Fax    
Email  ganavinayak18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaya A R 
Designation  Professor 
Affiliation  Rajarajeswari dental college and hospital bengaluru 
Address  Department of pediatric and preventive dentistry Rajarajeswari dental college and hospital NO 14 ramohalli cross, mysore road,bengaluru, karnataka560074

Bangalore
KARNATAKA
560074
India 
Phone  9880038038  
Fax    
Email  jaya.vrushabh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganavi G Nayak 
Designation  Post graduate student 
Affiliation  Rajarajeswari dental college and hospital bengaluru 
Address  Department of pediatric and preventive dentistry Rajarajeswari dental college and hospital NO 14 ramohalli cross, mysore road,bengaluru, karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  7624908255  
Fax    
Email  ganavinayak18@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari dental college and hospital NO 14 ramohalli cross,mysore road,bengaluru,karnataka 560074 
 
Primary Sponsor  
Name  Dr Ganavi G Nayak 
Address  Department of pediatric and preventive dentistry Rajarajeswari dental college and hospital NO 14 ramohalli cross,mysore road,bengaluru, karnataka 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 Ganavi G Nayak  Rajarajeswari dental college and hospital  Department of pedodontics and preventive dentistry Room number 5 Number 14 ramohalli cross, mysore road
Bangalore
KARNATAKA 
7624908255

ganavinayak18@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: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  salivary matrix metalloproteinase- 8 levels  Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of MI varnish( group 1) on primary carious teeth in children with early childhood caries  
Comparator Agent  Salivary matrix metalloproteinase-8 levels  Intergroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of MI varnish, 38% silver diamine fluoride and nano silver fluoride on primary carious teeth in children with early childhood caries. 
Comparator Agent  salivary matrix metalloproteinase-8 levels  Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of 38% silver diamine fluoride ( group 2) on primary carious teeth in children with early childhood caries.  
Comparator Agent  Salivary matrix metalloproteinase-8 levels  Intragroup evaluation and correlation of salivary matrix metalloproteinase-8 levels before and after one month and three month topical application of nano silver fluoride ( group 3) on primary carious teeth in children with early childhood caries. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Children with 3 to 6 years of age of both the genders
2.Children with DC greater than or equal to 3 in primary teeth , ICDAS II criteria, CODE 02 and 03
3.Parents giving consent for the study. 
 
ExclusionCriteria 
Details  1.Children who received fluoride topical application during the last 1 month.
2.Children requiring special health care needs.
3.Pulpally involved and grossly decayed teeth.
4.Children who were on antibiotic therapy within the past 3 months.
5. Children with genetic diseases or syndrome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate salivary MMP-8 levels before and after application of MI varnish, 38% SDF and NSF in children with ECC using ELISA.
 
Base line
1 month
3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation & comparision of intragroup & intergroup salivary MMP- 8 levels before & after application of MI varnish, 38% SDF & NSF in children with ECC using ELISA  Base line
1 month
3 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   12/08/2024 
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="2"
Months="0"
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  

A total of 45 children  who  meets  inclusion  criteria will be selected and divided into three  experimental groups, Group 1 ( n =15), Group 2 ( n = 15), Group  3 ( n= 15) . All   subjects will be instructed to refrain from eating  and drinking for 1 hour  before the saliva  sample collection. Pre-intervention unstimulated saliva sample will be collected by spitting method. The patients will be asked to rinse the mouth with filter water  twice before the collection . After the oral rinse, children  will be asked  to  spit  the saliva  into sterile tubes for a period of 5 minutes . Then these tubes will be sealed immediately after sample collection and refigerated at - 20 degree celsius and stored in  laboratory until further analysis. Group 1 - MI varnish, Group 2- 38% SDF , Group 3 -NSF will be applied on selected carious teeth  with micro brush and left for 2 minutes . Post  application  instructions will be given. Patients will be recalled after 1 month and 3 month and post- interventional unstimulated salivary samples will be collected by the same procedure as mentioned above. All samples will be subjected to ELISA to evaluate and compare salivary MMP- 8 levels. Results obtained will be subjected to statistical data.

 
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