| CTRI Number |
CTRI/2024/03/064932 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimation and comparison of salivary inflammatory biomarkers and alpha amylase in type 1 diabetic and non diabetic children |
|
Scientific Title of Study
|
Estimation and comparison of salivary cytokines and alpha amylase in whole saliva of children with 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 Priyanka N |
| Designation |
Post graduate student |
| Affiliation |
RajaRajeswari dental college and hospital |
| Address |
Dept of Pediatric and Preventive
Dentistry room no 5 ramohalli cross mysore road kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
9606833147 |
| Fax |
|
| Email |
priya30gani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Shakuntala |
| Designation |
Professor |
| Affiliation |
RajaRajeswari Dental college and hospital |
| Address |
Dept of Pediatric and Preventive Dentistry RajaRajeswari dental college and hospital ramohallicross mysore road kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
9945380455 |
| Fax |
|
| Email |
shakuntalabethur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka N |
| Designation |
Post graduate student |
| Affiliation |
RajaRajeswari Dental college and hospital |
| Address |
Dept of Pediatric and Preventive
Dentistry room no 5 RajaRajeswari dental college and hospital no 14 ramohalli cross mysore road kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
9606833147 |
| Fax |
|
| Email |
priya30gani@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari dental college |
|
|
Primary Sponsor
|
| Name |
DR PRIYANKA N |
| Address |
Dept OF Pediatric And Preventive Dentistry RajaRajeswari Dental College and Hospital kumbalgodu
Bengaluru Karnataka India |
| 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 Priyanka N |
RajaRajeswari dental college and hospital |
Department of Pediatric and Preventive Dentistry
RajaRajeswari Dental College and Hospital
No 14 Ramohalli cross Mysore Road Kumbalgodu Bengaluru Karnataka India
Bangalore
KARNATAKA |
9606833147
priya30gani@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: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1Children of 7-15 years of age.
2Children with insulin dependent type 1
diabetes mellitus disorder.
3Parents giving consent for the study
|
|
| ExclusionCriteria |
| Details |
1 Children with presence of any physical or mental
disorder.
2 Children requiring special health care needs.
3 Children with genetic diseases or syndromes.
4 Children on any other systemic medications.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare the levels of salivary cytokines using ELISA .To estimate and compare the levels of alpha amylase using UV spectrometer in diabetic and non-diabetic children |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| estimating the values of salivary cytokines |
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="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
|
The present
study will be done on 40 subjects including 20 children with confirmed type 1
diabetes and 20 diabetes free children aged 7-15 years to estimate and compare
the levels of salivary cytokines and alpha amylase in whole saliva among type 1
diabetic children and non-diabetic children an unstimulated salivary samples is
collected by spitting method The patients will be asked to rinse mouth
with filtered water twice before the collection after the oral rinse the
children will be asked to spit the saliva into sterile tubes for a period of 5
mins The collected volume of saliva will be measured in millimeters per minute
to estimate flow rate the tubes will then be sealed immediately after sample
collection and refrigerated at 4℃ before transporting to laboratory
for further analysis
|