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临床试验/CTRI/2024/04/065049
CTRI/2024/04/065049尚未招募Phase 3 4

Behavioral Support Intervention For Smokeless Tobacco Cessation At A Dental Setting

Indian Council of Medical Research (ICMR)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月10日最近更新:
适应症
相关药物

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Abstinence of smokeless tobacco use

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • •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.

结局指标

主要结局

Abstinence of smokeless tobacco use

时间窗: 1 week, 6 weeks, 9 weeks, 12 weeks and 24 weeks

次要结局

  • Urine cotinine test(Baseline & 24 weeks)

研究者

发起方
Indian Council of Medical Research (ICMR)
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Smitarani Priyadarshini

Institute of Dental Sciences

研究点 (1)

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