| CTRI Number |
CTRI/2014/01/004296 [Registered on: 07/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
07/01/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
a clinical trial to study the effects of periodontal therapy in Chronic Obstructive Pulmonary Disorder (COPD) patients. |
|
Scientific Title of Study
|
Effectiveness of periodontal therapy on quality of life, lung function, exacerbation rates and lung inflammation Chronic Obstructive Pulmonary Disorder (COPD) patients- Non randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushboo Thakkar |
| Designation |
Post Graduate student, Public Health Dentistry |
| Affiliation |
Dr D.Y. Patil Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
Dr D.Y. Patil Dental College and Hospital,
Sant Tukaram Nagar,
Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
khush.arien@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana Hegde Shetiya |
| Designation |
Professor and Head, Dept. of Public Health Dentistry |
| Affiliation |
Dr D.Y. Patil Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
Dr D.Y. Patil Dental College and Hospital,
Sant Tukaram Nagar,
Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
hegdesahana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushboo Thakkar |
| Designation |
Post Graduate student, Public Health Dentistry |
| Affiliation |
Dr D.Y. Patil Dental College and Hospital |
| Address |
Department of Public Health Dentistry,
Dr D.Y. Patil Dental College and Hospital,
Sant Tukaram Nagar,
Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
|
| Fax |
|
| Email |
khush.arien@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Dental College and Hospital, Pimpri, Pune. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Khushboo Thakkar |
Dr D.Y. Patil Dental College and Hospital |
Department of Public Health Dentistry, 2nd floor, dept no. 10
Pune
MAHARASHTRA |
9860248814
khush.arien@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr D.Y. Patil Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic obstructive pulmonary disorder patients having chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no treatment |
no treatment for control group |
| Intervention |
non surgical periodontal therapy |
Non surgical periodontal therapy includes thorough scaling and root planing after using a pre procedural mouth rinse. It also includes patient education and motivation, instructions for plaque control i.e. proper tooth brushing technique, use of chlorhexidine mouthwash, use of interdental oral hygiene aids and local drug delivery (if indicated).the treatment will be given at baseline and at evaluation times of 3 months and 6 months if necessary |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. COPD patients having chronic periodontitis.
2. Presence of atleast 20 teeth in the mouth.
3. Patients willing to quit smoking.
|
|
| ExclusionCriteria |
| Details |
1) Subjects having immunocompromised diseases and other debilitating diseases like asthma, epilepsy, diabetes mellitus, renal failure, hepatic diseases, cardiovascular disease, pneumonia.
2) Non ambulatory COPD patients.
3) Severe and very severe COPD patients.
4) Unwilling patients.
5) Patients who do not take regular medication for COPD.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of life of COPD patients |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| lung function, exacerbation rates and inflammatory mediators |
baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/02/2013 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 non randomized, single blind, parallel group trail to study the effectiveness of periodontal therapy in patients with Chronic Obstructive Pulmonary Disorder having chronic periodontitis. The primary outcome measures will be quality of life using St George’s Respiratory Questionnaire at 6 months. The secondary outcomes will be exacerbation rates, lung function tests and lung inflammation at 6 months. |