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Clinical Trials/CTRI/2024/04/065049
CTRI/2024/04/065049Not yet recruitingPhase 3 4

Behavioral Support Intervention For Smokeless Tobacco Cessation At A Dental Setting

Indian Council of Medical Research (ICMR)1 site in 1 country100 target enrollmentStarted: April 10, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Abstinence of smokeless tobacco use

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •All participants over the age of 18 who had been using smokeless tobacco exclusively for at least 6 months prior to the visit.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Abstinence of smokeless tobacco use

Time Frame: 1 week, 6 weeks, 9 weeks, 12 weeks and 24 weeks

Secondary Outcomes

  • Urine cotinine test(Baseline & 24 weeks)

Investigators

Sponsor
Indian Council of Medical Research (ICMR)
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr Smitarani Priyadarshini

Institute of Dental Sciences

Study Sites (1)

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