| CTRI Number |
CTRI/2024/02/062677 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of protein biomarkers in people suffering from periodontitis as well patient suffering from diabetes with periodontitis using protein-level analysis |
|
Scientific Title of Study
|
Proteomic analysis of gingival crevicular fluid for identification of protein biomarkers: An In vitro analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abinash patra |
| Designation |
PG student |
| Affiliation |
GITAM Dental college and hospital |
| Address |
Aurogreens Apartment Flat no 3B, , Behind omfed plant
Aurogreens Apartment Flat no 3B, , Behind omfed plant
ORISSA
751017
India |
| Phone |
08763333487 |
| Fax |
|
| Email |
abinashpatra96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P.Tanuja |
| Designation |
Professor,Department of periodontics |
| Affiliation |
GITAM Dental college and hospital |
| Address |
GITAM Dental college and hospital, Gandhinagar, Rushikonda, Vishakapatnam-530045
Gandhinagar, Rushikonda, Vishakapatnam-530045
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9441313131 |
| Fax |
|
| Email |
drtanujap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abinash patra |
| Designation |
PG student |
| Affiliation |
GITAM Dental college and hospital |
| Address |
Gitam dental college and hospital,Gandhi nagar Rushikonda,Vishakapatnam
Gandhinagar, Rushikonda, Vishakapatnam-530045
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
08763333487 |
| Fax |
|
| Email |
abinashpatra96@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM UNIVERSITY, Gandhinagar,
Rushikonda,Vishakapatnam |
|
|
Primary Sponsor
|
| Name |
GITAM university |
| Address |
GITAM UNIVERSITY, GANDHINAGAR, VISHAKAPATNAM |
| 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 ABINASH PATRA |
GITAM DENTAL COLLEGE AND HOSPITAL |
Department no 6, Department of periodontics,Gitam dental college and hospital,gandhinagar,rushikonda,Vishakapatnam
Visakhapatnam
ANDHRA PRADESH |
07008251232
abinashpatra96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, GITAM DENTAL COLLEGE, VISHAKAPATNAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Group A, Gingival sulcus depth of two to three milimeters,Systemically healthy individuals, Absence of periodontal disease
Group B,Individuals without diabetes mellitus,Pocket depth greater than equal to four milimeters,Clinical Attachment loss greater than four millimeters
Group C, Pocket depth of greater than four milimeters,Clinical attachment loss greater than four milimeters,Random blood sugar greater than two hundred miligram per mililitre,Under oral anti-diabetic medication
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Smokers and substance users
Unexposed to any medication other than oral anti diabetic drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of differential protein expression in gingival crevicular fluid as a potential biomarker of periodontal disease and diabetes mellitus. |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the differential protein expression in gingival crevicular fluid,To compare the differential protein expression in periodontal disease & diabetes mellitus
|
two months |
|
|
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)
|
01/03/2024 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study seeks to identify the protein biomarkers in systemically and periodontally healthy individuals, periodontitis patients and patients with diabetes mellitus by proteomic analysis of gingival crevicular fluid. The objective of this study is to identify the differential protein expression in gingival crevicular fluid and to compare the differential protein expression in periodontal disease and diabetes mellitus. The study includes individuals satisfying the inclusion criteria and providing consent for participation. The gingival crevicular fluid will be collected by non-invasive method which will be followed by protein extraction and separation.The process of proteomic analysis will be carried out at a certified laboratory. |