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CTRI Number  CTRI/2025/06/089839 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Checking mouth cleanliness and measuring vitamin D and bone-related protein in the spit of children with kidney disease and healthy kids: A one-time comparison study. 
Scientific Title of Study   Assessment of oral hygiene status and evaluation of 25(OH)D and RANKL levels in saliva of children with Nephrotic syndrome and healthy children: 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 SPURTHY JAVALAKAR 
Designation  Post graduate 
Affiliation  The Oxford Dental College Bangalore 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor,Room No 8, Bommanahalli, Hongasandra, Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor,Room No 8, Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9606599318  
Fax    
Email  spoorthijavalakar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SPURTHY JAVALAKAR 
Designation  Post graduate 
Affiliation  The Oxford Dental College Bangalore 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9606599318  
Fax    
Email  spoorthijavalakar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR BHARATH VARDHANA S 
Designation  Reader, Department of Pediatric and Preventive Dentistry 
Affiliation  The Oxford Dental College  
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  9886588595  
Fax    
Email  bharath.dentist@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  DR SPURTHY JAVALAKAR 
Address  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore 
Type of Sponsor  Research institution and hospital 
 
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 SPURTHY JAVALAKAR  The Oxford Dental College  The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No 8, Bommanahalli, Hongasandra, Bangalore
Bangalore
KARNATAKA 
9606599318

spoorthijavalakar@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children with Nephrotic Syndrome.
2. Age range of 6 to 14 years children under corticosteroids.
3. Children not on other medication unrelated to Nephrotic Syndrome.
4. Parent’s/ Patient’s consent for study.
 
 
ExclusionCriteria 
Details  1. Children with diseases other than Nephrotic Syndrome & taking medications for the same.
2. Children with other significant chronic disease.
3. Children who have undergone major surgery.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine the oral hygiene status of Nephrotic syndrome children and healthy children.  one and half year 
 
Secondary Outcome  
Outcome  TimePoints 
2. To determine and compare 25(OH)D and RANKL levels in saliva of Nephrotic syndrome children and healthy children.  one and half 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)   24/07/2025 
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="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 - NO
Brief Summary  

A total of sixty children fulfilling the inclusion criteria will be selected. Thirty Nephrotic syndrome children will form the study group and thirty age matched    healthy children will form the control group. Oral examination for Nephrotic syndrome children will be done at Sri Sai Kanva Hospital under natural daylight using a sterilized mouth mirror and CPITN probe (Community Periodontal Index for Treatment Needs). Oral examination for healthy children will be done at Department of Pediatric and Preventive Dentistry. Dental caries, plaque and gingival status will be assessed according to WHO criteria.

On completion of oral examination saliva samples will be collected in the morning from 09.00am to 11.00am and the children will be asked to avoid eating or drinking 1 hour before the collection of saliva samples. Unstimulated saliva samples will be collected using the spitting method. The subject is asked to sit comfortably for five minutes, then is asked to swallow the saliva in their oral cavity once, so measuring can commence. After that, their head is lowered and moved as little as possible (talking is restricted). During the measurement process the subject is not allowed to swallow. The saliva in their oral cavity is collected with lips closed and eyes open for one minute, then spitting will commence into a sterile container for five minutes. Saliva sample is transferred to eppendorf tube and stored in temperature controlled icebox. Within two hours of saliva sample collection, samples will be transferred to biochemistry laboratory for the assessment of 25(OH)D and RANKL levels in saliva by using enzyme- linked immune sorbent assay (ELISA). The centrifugation of 2500rpm is carried out for 10 minutes, and the specimen is immediately stored at      –20 oC. The samples are stored in lab at -80 oC for extended storage.  The obtained results will be subjected to statistical analysis.

 
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