| CTRI Number |
CTRI/2014/08/004898 [Registered on: 20/08/2014] Trial Registered Prospectively |
| Last Modified On: |
20/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY COMPARING THE INFLUENCE OF PERIODONTAL INFLAMMATION ON CARDIOVASCULAR CONDITION IN DIABETIC MELLITUS PATIENTS. |
|
Scientific Title of Study
|
EVALUATION OF THE EFFECT OF PERIODONTITIS ON C-REACTIVE PROTEIN LEVELS IN PATIENTS WITH TYPE II DIABETES MELLITUS.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Jose Kachapilly |
| Designation |
Post graduate student |
| Affiliation |
Kerala Universithy of health sciences, Thrissur |
| Address |
Department: periodintics, Mar Baselios Dental College, Kothamangalam,Kerala.Pin: 680696
Kerala Universithy of health sciences, Medical college P O, Thrissur, kerala, Pin-680596
Ernakulam
KERALA
686691
India |
| Phone |
9605577680 |
| Fax |
|
| Email |
tsbkgem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Majo Ambooken |
| Designation |
Head of department : Periodontics |
| Affiliation |
Kerala University of Health sciences |
| Address |
Department Periodontics, Mar Baselios Dental college
Department Periodontics, Mar Baselios Dental college
Ernakulam
KERALA
686691
India |
| Phone |
9605577680 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Jose Kachapilly |
| Designation |
Post Graduate student |
| Affiliation |
Kerala Universithy of health sciences, Thrissur |
| Address |
Department: Periodontics, Mar Baselios Dental college,Kothamangalam, Kerala, Pin-680696
Kerala Universithy of health sciences, Medical colleg PO, Thrissur, Kerala
Ernakulam
KERALA
686691
India |
| Phone |
9605577680 |
| Fax |
|
| Email |
tsbkgem@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARUN JOSE KACHAPILLY |
| Address |
DEPT: PERIODONTICS, MAR BASELIOS DENTAL COLLEGE, KOTHAMANGALAM,KERALA,PIN-686691 |
| Type of Sponsor |
Other [] |
|
|
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 |
| ARUN JOSE KACHAPILLY |
Department : Periodontics, room no 6 |
MAR BASELIOS DENTAL COLLEGE, KOTHAMANGALAM
Ernakulam
KERALA |
9605577680
tsbkgem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional ethical review committee, Mar Baselios dental college |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
TYPE 2 DIABETES, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 35 years and 60 years.
2) Physician diagnosed type II diabetes of more than six months duration.
3) Type II diabetes mellitus patients with glycated hemoglobin 7%-9 %.
4) Chronic Periodontitis patients according to criteria of American Academy of classification
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy or lactation
2) Patients with history of cardiovascular diseases, kidney disease, cancer, or fungal or respiratory Infections or any other systemic disorder except type II diabetes mellitus.
3) Patients with a history of hospitalization or intake of any medications known to affect the inflammation within the last 6 months.
4) Patients with a current or past habit of tobacco smoking or chewing.
5) Patients who received any periodontal therapy 6 months prior to the start of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| C-REACTVE PROTEIN LEVEL |
single visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| glycated hemoglobin value can be compared with c-reactve proetin levels |
single visit |
|
|
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)
|
23/08/2014 |
| 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="3"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY IS A CROSS SECTIONAL STUDY DONE ON 60 TYPE2 DIABETIC PATIENTS. BLOOD SAMPLES WILL BE COLLECTED AND INVESTIGATION OF GLYCATED HEMOGLOBIN AND C-REACTIVE PROTEIN WILL BE DONE.THE PRIMARY OUTCOME WILL BE LEVELS OF C-REACTIVE PROTEIN IN PERIODONTITIS AND NON-PERIODONTITIS SUBJECTS.THIS STUDY WILL HELP IN UNDERSTANDING THE LEVELS OF C-REACTIVE PROTEIN DUE TO PERIODONTAL INFLAMMATION IN DIABETIC SUBJECTS. |