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CTRI Number  CTRI/2025/04/085500 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective study 
Study Design  Other 
Public Title of Study   Comparison and evaluation of salivary biomarkers in children with insulin dependent type 1 diabetes mellitus and healthy children 
Scientific Title of Study   Comparison of salivary biochemical and immunological biomarker in children with insulin dependent type 1 diabetes mellitus and non- diabetic children 
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 Rajas Mahalle 
Designation  BDS,postgraduate student MDS 
Affiliation  Rajarajeshwari dental college and hospital, Kumbalgodu, bangalore 
Address  Department of pediatric and preventive dentistry, room no. 5, Rajarajeshwari dental college and hospital, kumbalgodu, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  7620502721  
Fax    
Email  rajasvi19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shakuntala B S 
Designation  BDS, MDS, prof and head of the department 
Affiliation  Professor and Head of the department, Rajarajeshwari dental college and hospital, Kumbalgodu, bangalore 
Address  department of pediatric and preventuve dentistry, room no 5, Rajarajeshwari dental college and hospital, kumbalgodu, bangalore.

Bangalore
KARNATAKA
560074
India 
Phone    
Fax    
Email  shakuntalabethur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajas Mahalle 
Designation  BDS,postgraduate student MDS 
Affiliation  Rajarajeshwari dental college and hospital, Kumbalgodu, bangalore 
Address  Department of pediatric and preventive dentistry, room no. 5, Rajarajeshwari dental college and hospital, Kumbalgodu, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  7620502721  
Fax    
Email  rajasvi19@gmail.com  
 
Source of Monetary or Material Support  
Rajareajeshwari dental college and hospital, Bangalore 
 
Primary Sponsor  
Name  Dr Rajas Mahalle 
Address  Department of pediatric and preventive dentistry, room no. 5, Rajarajeshwari dental college and hospital, kumbalgodu, bangalore. 560074 
Type of Sponsor  Research institution 
 
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 Rajas Mahalle  Rajarajeshwari dental college and hospital  Room no. 5, department of pediatric and preventive dentistry, RRDCH, bangalore
Bangalore
KARNATAKA 		 07620502721

rajasvi19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeshwari dental and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  children with insulin dependent T1DM
children of 5-15 years of age
parents giving consent 
 
ExclusionCriteria 
Details  children with less than 5 years and above 15 years with insulin dependent T1DM
children with presence of physical and mental disorder
children requiring special health care needs
children with genetic disease or syndromes
children on any other systemic medications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate and compare salivary biochemical, immunological and microbial factors among children with T1DM and healthy children  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 1 
Date of First Enrollment (India)   12/05/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rajasvi19@gmail.com].

  6. For how long will this data be available start date provided 22-04-2025 and end date provided 04-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Systemic disease such as diabetes compromises the salivary gland function and alteration in the chemical components and physical properties which can serve as diagnostic parameter. Saliva has several advantages such as easy storage, transport and handling, simple and non-invasive collection. The study is aimed to compare and evaluate biochemical, immunological and microbiological biomarker in children with insulin dependent diabetes mellitus and non-diabetic children. The present study will be conducted on 80 children including 40 children with confirmed type 1 diabetes mellitus and 40 diabetes free children in the age range of 5-15 years. All subjects will be instructed to refrain from eating and drinking for 1 hour before the saliva sample collection. The unstimulated saliva will be collected by spitting method. The goal of the study is to increase oral hygiene awareness of type 1 diabetes mellitus children and non- diabetic children . 
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