|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2014/08/004898 |
|
Date of registration:
|
20-08-2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A STUDY COMPARING THE INFLUENCE OF PERIODONTAL INFLAMMATION ON CARDIOVASCULAR CONDITION IN DIABETIC MELLITUS PATIENTS.
|
|
Scientific title:
|
EVALUATION OF THE EFFECT OF PERIODONTITIS ON C-REACTIVE PROTEIN LEVELS IN PATIENTS WITH TYPE II DIABETES MELLITUS.
|
|
Date of first enrolment:
|
23-08-2014 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Not Yet Recruiting |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9714 |
|
Study type:
|
Observational |
|
Study design:
|
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
DR Majo Ambooken
|
|
Address:
|
Department Periodontics, Mar Baselios Dental college Department Periodontics, Mar Baselios Dental college
686691
Ernakulam, KERALA
India |
|
Telephone:
|
9605577680 |
|
Email:
|
drmajoa@gmail.com |
|
Affiliation:
|
Kerala University of Health sciences |
|
|
Name:
|
Arun Jose Kachapilly
|
|
Address:
|
Department: Periodontics, Mar Baselios Dental college,Kothamangalam, Kerala, Pin-680696 Kerala Universithy of health sciences, Medical colleg PO, Thrissur, Kerala
686691
Ernakulam, KERALA
India |
|
Telephone:
|
9605577680 |
|
Email:
|
drmajoa@gmail.com |
|
Affiliation:
|
Kerala University of Health sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 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
Exclusion criteria: 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.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- TYPE 2 DIABETES
|
|
Primary Outcome(s)
|
C-REACTVE PROTEIN LEVELTimepoint: single visit
|
|
Secondary Outcome(s)
|
|
glycated hemoglobin value can be compared with c-reactve proetin levelsTimepoint: single visit
|
|
Source(s) of Monetary Support
|
|
self funding
|
|
Ethics review
|
Status: Approved
Approval date: 22/01/2014
Contact:
Institutuional ethical review committee, Mar Baselios dental college
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|