| CTRI Number |
CTRI/2012/06/002748 [Registered on: 26/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/06/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Estimate the Prevalence of dental problems in Type 1 and Type 2 Diabetic and Non-Diabetic Patients
|
|
Scientific Title of Study
|
Prospective Comparative Study to Estimate the Prevalence of Periodontitis in Type 1 and Type 2 Diabetic and Non-Diabetic Patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PPDN001 version 1.1 Date 2nd May 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
mohammad afzal |
| Designation |
trainee |
| Affiliation |
max super speciality hospital |
| Address |
clinical research department 6 th floor 2 press enclave road saket new delhi
New Delhi
DELHI
110017
India |
| Phone |
8826655872 |
| Fax |
|
| Email |
muhammad.afzl@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeet Jha |
| Designation |
Director: Institute of Endocrinology & obesity |
| Affiliation |
max super speciality hospital |
| Address |
Endocrinology Department
5th floor 2 press enclave road saket new delhi
New Delhi
DELHI
110017
India |
| Phone |
8826655872 |
| Fax |
|
| Email |
sujeet.jha@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
mohammad afzal |
| Designation |
trainee |
| Affiliation |
max super speciality hospital |
| Address |
clinical research department 6 th floor 2 press enclave road saket new delhi
New Delhi
DELHI
110017
India |
| Phone |
8826655872 |
| Fax |
|
| Email |
muhammad.afzl@hotmail.com |
|
|
Source of Monetary or Material Support
|
| max super speciality hospital |
|
|
Primary Sponsor
|
| Name |
max super speciality hospital |
| Address |
2 press enclave road saket new delhi 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 sujeet jha |
Max Super Speciality Hospital |
Endocrinology Department 5th floor
2 press enclave road
saket
new delhi 110017
New Delhi
DELHI |
8826655872
sujeet.jha@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| max superspeciality hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Periodontitis , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
case inclusion criteria
1)Subject aged over 18 years old.
2)Patients having diagnosis of type 1 or type 2 diabetes as defined by American Diabetes Association (ADA 2011) criteria.
3)Subject able to provide consent to participate in the study.
CONTROL Inclusion Criteria
1)Males and females of age between 18-80.
2)Absence of diagnosed type 1 and type 2 diabetes mellitus or any history of diabetes i.e. HbA1c level< 6.5
3)Subject able to provide consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
CASE Exclusion Criteria:
Patient with recent periodontal treatment for atleast 3 months.
CONTROL Exclusion Criteria
Pregnant or lactating women.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Presence of periodontitis in type 1and type 2 diabetic and non-diabetic patients
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcome |
n/a |
|
|
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)
|
05/06/2012 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Estimation of the prevalence periodontitis in type
1 and type 2 diabetic patients as compared with non-diabetic patients
The hypothesis being
tested is:
H0: pT= pC vs. H1: pT ≠pC
Where pT and pC are the
proportion of depression in diabetes and non diabetes groups respectively,
rejection of the null hypothesis at a two sided significance level of 0.05
indicates a significant difference between two arms
|