| CTRI Number |
CTRI/2018/01/011290 [Registered on: 12/01/2018] Trial Registered Prospectively |
| Last Modified On: |
12/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Periodontitis and Asthma |
|
Scientific Title of Study
|
Association of Serum Ferritin Levels In Chronic Periodontitis And
Asthmatic Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirosha v |
| Designation |
Post graduate |
| Affiliation |
Narayana dental college |
| Address |
Department of Periodontics
2nd floor Room No 5
Narayana Dental College
Chinthareddypalem
Nellore
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9885616225 |
| Fax |
|
| Email |
drniroshayadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaykumar Chava |
| Designation |
Proffesor & head |
| Affiliation |
Narayana Dental College |
| Address |
Department of periodontology
narayana dental college
chintareddypalem
nellore
Narayana Dental College
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaykumar Chava |
| Designation |
Proffesor & head |
| Affiliation |
Narayana Dental College |
| Address |
Department of periodontology
narayana dental college
chintareddypalem
nellore
Narayana Dental College
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics
Narayana Dental College
Nellore |
|
|
Primary Sponsor
|
| Name |
V Nirosha |
| Address |
Department of Periodontics
Narayana Dental college, Nellore |
| 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 |
| Nirosha V |
Narayana Dental College |
Department of Periodontology
Room No 5 2nd floor
Narayana dental college hospital
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH |
9885616225
drniroshayadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Narayana Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asthma and Periodontitis
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
Serum Ferritin |
To Compare and evaluate the serum Ferritin levels in Asthma and Periodontitis Patient |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderate asthmatic patient by calculating FEVI/FVCX100 on the basis of spirometer (Vikas Deo, et.al, 2009).
2. Normal BMI index (18.5-24.99).
|
|
| ExclusionCriteria |
| Details |
1. Patients who had received periodontal therapy with in 6months before study
2. Patient receiving ferritin supplements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| periodontitis in Asthmatics |
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare clincal parameters with biochemical parameters |
NA |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/01/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Clinico biochemical study will be conducted in Department of Periodontology, Narayana Dental College & Hospital, Nellore, AP, INDIA to correlate serum ferritin levels in asthmatic patients from department of Pulmonology, Narayana Medical College, Nellore. Two ml of blood will be collected by venipuncture from all the selected patients to determine the serum ferritin levels.Based on the above criteria the individuals (120) are divided into 4 groups Group I - Healthy individuals Group II - Patients with Asthma Group III - Patients With chronic periodontitis and Asthma Group IV - Patients with chronic periodontitis. Clinical parameters like plaque index, bleeding index,Pocket depth,clinical attachment level will be recorded using periodontal probe.Blood serum will be collected and subjected to serum ferritin analysis in all 4 groups.Then the values will be subjected for Statistical analaysis.
|