| 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
|
|
|
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
|
|
|
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
|
|
|
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. |