| CTRI Number |
CTRI/2025/09/095202 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Salivary and Blood Creatinine Levels in Normal and Chronic Kidney Disease Patients. |
|
Scientific Title of Study
|
Assessment and Comparison of Salivary and Serum Creatinine Levels in Patients having Chronic Kidney Disease and Systemically Healthy Patients: A Comparative 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 |
Arnavhi Burman |
| Designation |
BDS Intern |
| Affiliation |
VSPMDCRC Nagpur |
| Address |
VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019
NIL
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7263855589 |
| Fax |
|
| Email |
apburman27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arnavhi Burman |
| Designation |
BDS Intern |
| Affiliation |
VSPMDCRC Nagpur |
| Address |
VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019
NIL
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7263855589 |
| Fax |
|
| Email |
apburman27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arnavhi Burman |
| Designation |
BDS Intern |
| Affiliation |
VSPMDCRC Nagpur |
| Address |
VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019
NIL
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7263855589 |
| Fax |
|
| Email |
apburman27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arnavhi Burman |
VSPMDCRC, Nagpur |
Digdoh Hills, Hingna Road,Nagpur 440019
Nagpur
MAHARASHTRA |
7263855589
apburman27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Chronic Kidney Disease Stage 3 to 5.
Those willing to perform informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with Salivary Gland Disorders and Infections, patients on medication affecting Salivary secretions, patients with oral lesions or systemic conditions altering Salivary composition and those with history of Radiation therapy to Head and Neck. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A significant correlation is expected between Salivary Creatinine Levels and Serum Creatinine Levels in patients with Chronic Kidney Disease |
A significant correlation is expected between Salivary Creatinine Levels and Serum Creatinine Levels in patients with Chronic Kidney Disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/10/2025 |
| 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="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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 18-06-2026 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Sampling blood for serum analysis is an invasive procedure A noninvasive alternative would be beneficial to patients and health care professionals Aim To Analyze Relationship between Creatinine levels in Serum and Saliva Study Design Case control Study Methods Blood and Saliva samples will be collected from 35 Healthy individuals and 35 Chronic Kidney Disease patients and measured and analyzed in laboratory Statistical Analysis The serum and salivary creatinine levels between controls and cases will be compared using t test Correlation between Serum and Salivary creatinine will be obtained in controls and cases using Pearson correlation coefficient Result Serum and Salivary creatinine levels will be significantly higher in CKD patients than controls Expected outcome is that Saliva can be used as a noninvasive alternative to serum for Creatinine estimation |