| CTRI Number |
CTRI/2020/08/027132 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
11/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Importance of Provider Feedback from Patients about Quitting Tobacco to Dentists in Dental Care Setting |
|
Scientific Title of Study
|
Effectiveness of Provider Feedback to Assess the Tobacco Cessation Counselling by Dentists in Dental Care Setting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Vinod kumar |
| Designation |
PG Student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry,Room-6,The Oxford Dental College,Bommanahalli,Hosur road,Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
9986024502 |
| Fax |
|
| Email |
vinoddeolkar007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpashree KB |
| Designation |
Guide |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry,Room-6,The Oxford dental college,Bommanahalli,Hosur Road,Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
9980840073 |
| Fax |
|
| Email |
shilpakris19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Vinod Kumar |
| Designation |
PG Student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry,Room-6,The Oxford Dental College,Bommanahalli,Hosur road,Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
9986024502 |
| Fax |
|
| Email |
vinoddeolkar007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public health Dentistry,Room-6,The Oxford Dental College, Bommanahalli,Hosur Road,Bangalore 560068. |
|
|
Primary Sponsor
|
| Name |
M Vinod Kumar |
| Address |
Department of Public Health Dentistry,Room-6,The Oxford Dental College,Bommanahalli,Hosur Road,Bangalore 560068 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dental care setting |
Muthus Molarzzz dental clinic,opposite More megastore,Nagavarapalya,CV Raman Nagar Post,Bangalore 560093 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinod |
The Oxford Dental College |
Department of Public Health Dentistry,Room-6,The Oxford Dental College,Bommanahalli,Hosur road,Bangalore.
Bangalore
KARNATAKA |
9986024502
vinoddeolkar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,THE OXFORD DENTAL COLLEGE, BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Tobacco Counselling |
Patients without Tobacco Counselling in Dental Care Setting.
Duration upto 6 months. |
| Intervention |
Tobacco Cessation Counselling |
Tobacco Cessation Counselling to Patients in Dental Care Setting.
Duration upto 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Dentists who give consent to Participate in study.
Dentist inclined to undergo Tobacco Cessation Counselling training and Implementation.
Patient should be a current smoker.
Patient willing to quit the habit of smoking. |
|
| ExclusionCriteria |
| Details |
Dentists who do not give consent to participate in study.
Patient not willing to quit the habit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tobacco Cessation Counselling by Dentists |
7 Days,3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tobaccco cessation by Patients |
7 Days,3 Months, 6 Months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
17/08/2020 |
| 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="1"
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)?
Response - NO
|
|
Brief Summary
|
Tobacco has been the long known cause of Oral cancer. Dentists are the first to record the changes due to tobacco consumption in the oral cavity of the patients. They diagnose oral cancer with a routine oral screening of patients. This study attempts to test the effect of feedback given by the patients in training the dentists carrying out the tobacco cessation counselling. Responsibility lies with both the clinician and the health care system to ensure that atleast a brief intervention need to be given to every tobacco user. Although many smokers are reluctant to seek intensive treatment they nevertheless can receive a brief intervention every time they visit a clinician. The strategy is to ensure that all patients are asked about tobacco use as part of every clinical encounter. Such prompts have been shown to increase the rate at which clinicians intervene with tobacco using patients. In addition to patients counselling by the clinicians, feedback by the patients is widely used as a strategy to improve professional practice either on its own or as a component of multifaceted quality improvement interventions. |