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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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. 

 
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