| CTRI Number |
CTRI/2024/04/065049 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Behavioral Support for Quitting Smokeless Tobacco Habit at a Dental Setting |
|
Scientific Title of Study
|
Behavioral Support Intervention For Smokeless Tobacco Cessation At A Dental Setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smitarani Priyadarshini |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Institute of Dental Sciences, K-8, Kalinga Nagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
8339999846 |
| Fax |
|
| Email |
smitapriyadarshini@soa.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saplin Pradhan |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Institute of Dental Sciences, K-8, Kalinga Nagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
9437019578 |
| Fax |
|
| Email |
dr.saplinpradhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Susmita Sahu |
| Designation |
Final Year Student |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology, Institute of Dental Sciences, K-8, Kalinga Nagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
8328982315 |
| Fax |
|
| Email |
susmitasahu13579@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Ansari Nagar, New Delhi- 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Smitarani Priyadarshini |
Insitute of Dental Sciences |
Room No. 101, Department of Oral Medicine and Radiology, Tobacco Cessation Centre, Institute of Dental Sciences, K-8, Kalinga Nagar, Bhubaneswar Khordha ORISSA |
8339999846
smitapriyadarshini@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All participants over the age of 18 who had been using smokeless tobacco exclusively for at least 6 months prior to the visit. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BISCA |
face-to-face behavioural support for SLT cessation [Assisted] The intervention is provided for 15-20 minutes to each participant. After the quit date, the intervention is focused on avoiding relapse.
Telephonic follow-up will be done on the seventh day, 15th day, 4 weeks, 8 weeks, 16 weeks, and 24 weeks for the interventional group to assess the change in the frequency of use of smokeless tobacco products, slips, relapses, and abstinence. |
| Comparator Agent |
Motivational Interviewing [Self Help] |
A brief advice regarding the benefits of smokeless tobacco cessation at the start of the intervention, which included ask, warn, advice, refer, do (AWARD) along with a printed manual for SLT cessation.
With follow up on seventh day, 15th day, 4 weeks, 8 weeks, 16 weeks, and 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All participants over the age of 18 who had been using smokeless tobacco exclusively for at least 6 months prior to the visit. |
|
| ExclusionCriteria |
| Details |
Participants with any acute or chronic disease that prevented them from effectively participating in the experiment, as well as those under treatment for psychiatric disorders, were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Abstinence of smokeless tobacco use |
1 week, 6 weeks, 9 weeks, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urine cotinine test |
Baseline & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prevalence
of smokeless tobacco (SLT) use is predominant in India.
It accounts for some of the highest rates of smokeless tobacco use
and Oral cancer in the world. SLT is consumed by
more than 350 million individuals worldwide; approximately 85% of users are
concentrated in South and South-East Asia. In these low-resource
settings where SLT is culturally ingrained, it remains cheap, widely available
and poorly regulated. South and South-East Asian SLT products often contain
stimulants and flavorings that enhance flavor and addictiveness. On the other
hand, their preparation methods induce high levels of free nicotine, Tobacco
Specific Nitrosamines and heavy metals. Due to their composition SLT products
are highly addictive and toxic. More than 40 types of SLT like paan, paan
masala, khaini, zarda, mawa, gutka and mishri and gudakhu are used in chewing,
snuffing and applying in teeth and gums. SLT
cessation intervention-based research needs encouragement; Behavioral
interventions have been proven to be an efficacious and feasible modality for
tobacco cessation in all setting. Sensitization and imparting of training
regarding the same use prevention and cessation-related programs need to be
encouraged. Patients who visit the dental hospital may not be motivated to quit
the habit of tobacco chewing. Tobacco smokers who receive
intervention from oral health professionals in the dental office are more
likely to quit. Nevertheless, due to the small number of trials evaluated, it
is difficult to establish the most important component of the cessation
intervention. |