Cessation of Smokeless Tobacco Use Assessing the combined effectiveness of Nicotine replacement therapy and Tobacco cessation counselling in achieving abstinence from smokeless tobacco use by evaluating quit rates three months post intervention A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- To evaluate quit rates of smokeless-tobacco use
研究概览
简要总结
This study is a Randomization control trial
Duration: six months (Recruitment: 1 month, Follow up 3
months, Data analysis and presentation: 2 months)
• Follow up: three months
• Based on inclusion and exclusion criteria the volunteers will be
recruited in the study.
ORAL CANCER SCREENING
• subjects attending oral cancer screening campaign and Tobacco Cessation Center .
• Participants who consume smokeless tobacco, have tried quitting atleast one week and willing to
participate will be selected in the study.
• Demographic data (Name, age, gender, education, family
income, occupation) will be collected.
• Participants will be questioned regarding their habits – type,
amount, frequency and duration.
• Intra oral examination will be done and detection of commonly
seen lesions like leukoplakia, erythroplakia, oral submucous fibrosis and
tobacco pouch keratosis.
• Participants detected with lesions will be separately followed up
for the treatment.
• Dentition status of the participants will be examined.
• An informed consent will be taken prior to the study from the
participants who are willing to take part in the study.
PHASE 2:
• Volunteers will be divided into two groups with details of the
intervention and control as follows: Intervention group will receive intensive counselling by the dentist similar to the control group.
In addition, they will receive the Nicotin replacement therapy intervention. Follow-up will be done for 3 months
Control group will receive intensive tobacco cessation counselling by dentists(Ask and Advise component of the intervention) and placebo therapy.
• After three months follow up quit rates will be assessed by Cotinine test kit
for those participants who claim to have quit the habit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients attending oral cancer screening campaign Those who use smokeless form of tobacco or mixed.
- •Who have tried quitting for atleast one week in past two months and failed and still willing to quit.
- •Those who have responded during the follow up phone calls after enrolling in the camps.
- •Patients from Tobacco cessation center at the hospital who have tried quitting for atleast one week in past two months and failed and still willing to quit.
- •Patients aged 18 and above.
排除标准
- •Who use exclusively smoking form of tobacco.
- •Who are not willing to quit the habit.
- •Patients with pre cancerous oral lesions.
结局指标
主要结局
To evaluate quit rates of smokeless-tobacco use
时间窗: To evaluate quit rates of | at the end of 12 weeks after the intervention
after tobacco cessation cunselling and Nicotine replacement therapy intervention.
时间窗: To evaluate quit rates of | at the end of 12 weeks after the intervention
次要结局
- To estimate the prevalence of tobacco use,(willingness to quit and)
研究者
DrAkshata Agnihotri
SDM College Of Dental science and Hospital