| CTRI Number |
CTRI/2022/10/046889 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
TO EVALUATE THE OCCURRENCE OF THE DIFFERENT GENOTYPES OF THE RECEPTORS AND LIGANDS (CCL3, CCL5 AND CCR5) INVLOVED IN GUM AND SURROUNDING BONE DISEASE OF TEETH. |
|
Scientific Title of Study
|
CC CHEMOKINE RECEPTOR 5, CC CHEMOKINE LIGANDS 3 AND 5 GENE POLYMORPHISMS IN PATIENTS WITH PERIODONTITIS- A CASE-CONTROL STUDY |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S SANGEETHA |
| Designation |
PROFESSOR |
| Affiliation |
SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM, CHENNAI, TAMIL NADU
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S SANGEETHA |
| Designation |
PROFESSOR |
| Affiliation |
SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM, CHENNAI, TAMIL NADU
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S SANGEETHA |
| Designation |
PROFESSOR |
| Affiliation |
SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI |
| Address |
SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM, CHENNAI, TAMIL NADU
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [nil] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AYSHWARYA KARTHIKA MURALIDHARAN |
SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI, 600089 |
DEPARTMENT OF PERIOODONTICS, SRM DENTAL COLLEGE, BHARATHI SALAI, RAMAPURAM, CHENNAI
Chennai
TAMIL NADU |
8754266047
ayshudharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL REVIEW BOARD |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients of age 30-60 are to be recruited for the study.
2. Ethnic Tamilian subjects.
3. Control group to include subjects with no signs of periodontal disease and probing sulcus depth of ≤ 3mm with no evidence of clinical attachment loss.
4. Test group to include patients with Probing Pocket Depth of ≥ 5mm and/or Clinical Attachment Loss of ≥3mm in greater than 30% of sites with chronic periodontitis.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any inflammatory systemic conditions such as diabetes mellitus, rheumatoid arthritis, etc.
2. Patients with immunodeficiency disorders.
3. Patients with local modifiers like food impaction, factitious habits and bruxism.
4. Patients who smoke.
5. Use of orthodontic and prosthetic appliances.
6. Patients who had taken systemic antibiotic, anti-inflammatory, hormonal or other assisted drug therapy in the last 6 months or prior to the study. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1. The distribution of genotype and allele frequencies are to be assessed.
2. Plaque Index -PI (Loe and silness,1964)
3. Modified Sulcular bleeding index -mSBI (Mombelli, 1987)
4. Probing pocket depth (PPD)
5. Clinical attachment level (CAL) |
BASELINE |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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)
|
15/11/2022 |
| 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="2"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Genetic factors play a remarkable role in the predisposition and progression of periodontal disease. Hence it is plausible to hypothesize that the genetic polymorphisms of these chemokines and their receptor may predispose or protect the individuals from developing periodontitis. Hence the aim of the present study is to compare the association of CCR5 G59029A, CCL5 -28 C/G and CCL3 459 C/T gene polymorphisms in patients with periodontitis. |