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

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.