| CTRI Number |
CTRI/2024/11/077371 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation Between Dental Caries and Salivary Albumin in Adult Population In Haryana |
|
Scientific Title of Study
|
Evaluation of Correlation Between Dental Caries and Salivary Albumin in Adult Population In Haryana:
An In-Vivo 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 Deepti Nandana |
| Designation |
Post Graduate Student |
| Affiliation |
SGT UNIVERSITY |
| Address |
137,Mission Compound, Saharanpur Room No. 204,2nd Floor,
Department of Conservative Dentistry and Endodontics, SGT Dental
College Hospital And Research Institute, SGT University, Gurugram,
Haryana.
Gurgaon
HARYANA
122505
India |
| Phone |
7905191893 |
| Fax |
|
| Email |
drdepp011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashtha Arya |
| Designation |
PROFESSOR |
| Affiliation |
SGT UNIVERSITY |
| Address |
Room NO.204, 2nd Floor, Department of Conservative Dentistry And
Endodontics, SGT Dental College Hospital And Research Institute,
SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
drashthaarya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashtha Arya |
| Designation |
PROFESSOR |
| Affiliation |
SGT UNIVERSITY |
| Address |
Room NO.204, 2nd Floor, Department of Conservative Dentistry And
Endodontics, SGT Dental College Hospital And Research Institute,
SGT University, Gurugram, Haryana
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
drashthaarya@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Room no. 204, Department Of Conservative Dentistry and Endodontics, SGT Dental College
Hospital And Research Institute, Gurugram, Haryana. India. PIN code- 122505 |
|
|
Primary Sponsor
|
| Name |
SGT UNIVERSITY |
| Address |
SGT Dental College Hospital And Research Institute, SGT
University, Gurugram, Haryana- 122505 |
| 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 Deepti Nandana |
SGT UNIVERSITY |
Room NO.204, 2nd
Floor, Department of
Conservative Dentistry
And Endodontics, SGT
Dental College Hospital
And Research Institute,
Gurugram, Haryana
Gurgaon
HARYANA |
7905191893
drdepp011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
saliva samples collected from subject |
saliva samples will be collected from subjects and albumin collected from it.
Duration- 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy, compliant and consenting patients with dental caries and free from any systemic and local disease affecting saliva secretion. |
|
| ExclusionCriteria |
| Details |
Patients having periodontal disease, hypertension, diabetes, radiotherapy, chemotherapy,
systemic disease of vital organs and history of long-term medications will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the relationship between dental caries and salivary albumin in unstimulated saliva of
adult population in Haryana with varying caries experience as determined by their Decayed
Missing Filled Teeth (DMFT) scores. |
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
06/12/2024 |
| 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="0"
Months="4"
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 60 subjects will be selected based on exclusion and inclusion criteria. Occlusal surface of teeth will be cleaned and DMFT score calculated, based on which subjects will be divided into four groups. Unstimulated (resting) saliva samples will be collected by drool method in eppendorf tube.
During saliva collection the subject will be seated in the dental chair in upright position. The
unstimulated saliva will be collected by asking the subjects to pool the saliva in the floor of the
mouth and then asked to drool it out into eppendorf tube. The collected saliva will be centrifuged at 3000 rpm for 15 minutes and the supernatant will be
separated. The sample will then be refrigerated at − 10°C till the evaluation of albumin level.
Salivary albumin will be estimated using the Bromocresol green method (albumin colorimetric
test) with help of Agappe albumin kit. The results obtained will be analysed statistically. Data will be entered in Microsoft excel spread
sheet and analysed using SPSS software.
|