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CTRI Number  CTRI/2025/07/090686 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measuring saliva levels of YKL-40 and LL-37 in children with Down syndrome: A study of 8 - 15 years old. 
Scientific Title of Study   Evaluation of YKL-40 and LL-37 levels in saliva of children with Down syndrome: A cross sectional 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 Prapti Subhash Gayakwad 
Designation  Post Graduate Student 
Affiliation  The Oxford Dental College Bangalore 
Address  Bommabahalli, NH 44 Hongasandra , Bengaluru,
Cauvery Serenity , Yeshwanthpur Industrial Area, 560022
Bangalore
KARNATAKA
560068
India 
Phone  09742679736  
Fax  9742679736  
Email  prapti6198@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MADHUSUDHAN. K . S 
Designation  READER 
Affiliation  The Oxford Dental College Bangalore 
Address  THE OXFORD DENTAL COLLEGE, BOMMANAHALI, BANGALORE, KARNATAK ,560068
THE OXFORD DENTAL COLLEGE, BOMMANAHALI, BANGALORE, KARNATAK ,560068
Bangalore
KARNATAKA
560068
India 
Phone  9886035137  
Fax  9886035137  
Email  sudhannks@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prapti Subhash Gayakwad 
Designation  Post Graduate Student 
Affiliation  The Oxford Dental College Bangalore 
Address  Bommabahalli, NH 44 Hongasandra , Bengaluru,
Cauvery Serenity , Yeshwanthpur Industrial Area, 560022
Bangalore
KARNATAKA
560068
India 
Phone  09742679736  
Fax  9742679736  
Email  prapti6198@gmail.com  
 
Source of Monetary or Material Support  
Dr. Prapti Subhash Gayakwad Memera plaza AECS B Block , Wellington paradise, Singhsandra, Bangalore, Karnataka, 560068 
 
Primary Sponsor  
Name  Dr Prapti Subhash Gayakwad 
Address  Menera Plaza Singhsandra , AECS B Bloc, Wellington Paradise, Bangalore, Karnataka, India 560068 
Type of Sponsor  Other [] 
 
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 Prapti Subhash Gayakwad  The Oxford Dental College  The Oxford Dental College Room no. 8 fourth floor Bommabahalli, NH 44 Hongasandra , Bengaluru 560068
Bangalore
KARNATAKA 		 9742679736
9742679736
prapti6198@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE OXFORD DENTAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Children with Down Syndrome in the age group of 8 to 15years.
2. Cooperative children based on Frankel behaviour rating scale 3 and 4 
 
ExclusionCriteria 
Details  1. Children on long term medication
2. Down syndromic children who were extremely uncooperative
3. Children if they had taken antibiotics or anti inflammatory drugs
4. Children with severs intellectual disability and or cardiac condition present along with Down Syndrome. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
8 weeks  base line 
 
Secondary Outcome  
Outcome  TimePoints 
Inflammatory biomarker levels will be higher in Down syndrome patients.  One year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/09/2025 
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="2"
Days="1" 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [prapti6198@gmail.com].

  6. For how long will this data be available start date provided 14-04-2024 and end date provided 14-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a cross sectional study, double blinded, single center trial comparing the levels of YKL-40 and LL-37 levels in the saliva of children with Down syndrome and healthy children in 8 to 15 years old children that will be conducted in India. This study will be carried over the period of six months, and the saliva sample collection will be done in Coachmans position. The samples will be stored in -80 degrees after centrifugation. After collection of all the samples they will be sent for ELISA running and the data will be subjected to the statistical analysis. 
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