| CTRI Number |
CTRI/2020/03/023926 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Cystatin-C in periodontal health and disease |
|
Scientific Title of Study
|
EVALUATION OF CYSTATIN – C PROTEIN & CST3 GENE EXPRESSION IN PERIODONTAL HEALTH AND DISEASE: AN OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeneffar Roselin C |
| Designation |
Post graduate |
| Affiliation |
SRM Dental college and hospitals, Ramapuram |
| Address |
50, Mitta office street,
Krishnapuram,
Kadayanallur,
Tenkasi District.
SRM Dental college
Bharathi Salai
Ramapuram
Chennai - 600089
Tamilnadu
Chennai
TAMIL NADU
627759
India |
| Phone |
8939177390 |
| Fax |
|
| Email |
jeneffar2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeneffar Roselin C |
| Designation |
Post graduate |
| Affiliation |
SRM Dental college and hospitals, Ramapuram |
| Address |
50, Mitta office street,
Krishnapuram,
Kadayanallur,
Tenkasi District.
SRM Dental college
Bharathi Salai
Ramapuram
Chennai - 600089
Tamilnadu
TAMIL NADU
627759
India |
| Phone |
8939177390 |
| Fax |
|
| Email |
jeneffar2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepa Ponnaiyan |
| Designation |
Reader |
| Affiliation |
SRM Dental college and hospitals, Ramapuram |
| Address |
F4, Rajendra apartments,
No: 9 , Babu rajendra prasad, 1st Street, West mambalam.
SRM Dental college
Bharathi Salai
Ramapuram
Chennai - 600089
Tamilnadu
Chennai
TAMIL NADU
600033
India |
| Phone |
9884358568 |
| Fax |
|
| Email |
deepa_ponnaiyan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jeneffar Roselin C |
| Address |
50, Mitta office street,
Krishnapuram,
Kadayanallur,
Tenkasi District - 627759 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jeneffar Roselin C |
SRM Dental college |
4th floor
Department of Periodontics
Bharathi Salai
Ramapuram
Chennai 600089
Chennai
TAMIL NADU |
8939177390
jeneffar2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group ɪ - Periodontally healthy subjects
1) Systemically and periodontally healthy subjects planning for extraction due to orthodontic treatment.
Group ɪɪ - Chronic periodontitis subjects
2) Patients with Stage III / IV periodontitis exhibiting sites with PPD ≥ 6 mm, CAL ≥ 5 mm (According to 2017 World Workshop on Classification of Periodontal Diseases and Conditions). |
|
| ExclusionCriteria |
| Details |
1) Patients with systemic condition or diseases influencing the course of periodontitis including renal diseases and Alzheimer’s disease.
2) History of periodontal treatment within the previous six months.
3) Antimicrobial therapy, immunosuppressants within the previous six months.
4) Smokers and alcoholics.
5) Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the expression of Cystatin-C gene (CST3) in healthy and periodontitis subjects using real time PCR |
at baseline |
|
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Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2020 |
| Date of Study Completion (India) |
10/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/09/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal diseases are characterized by the inflammation and destruction of supporting
tissues of the teeth. Cysteine proteinases are among
the mediators secreted as a part of host response that leads to the tissue
destruction. Furthermore, based on the literature evidences, Cystatin C an inhibitor of cysteine
proteinases could play a protective and
regulatory role under inflammatory conditions. Its role as a biomarker in periodontal diseases is
also controversial. Evaluating
the levels of Cystatin C protein expression within GCF and Cystatin C gene
(CST3) expression in periodontal tissues together will give more clarity on its
role in periodontal disease progression. Till
date, no study has evaluated the gene expression of Cystatin C in periodontal
health and disease condition. Therefore this observational study aims to evaluate the of
Cystatin-C protein and CST3 gene in
periodontal health and disease. A total of 50 subjects are to be recruited with 25 each in healthy and periodontitis groups. GCF and tissues samples are to be collected at baseline and stored at -80 degree celsius. Further the protein and gene expression of Cystatin C will be evaluated using ELISA and RT-PCR respectively. |