Effectiveness of three different tobacco smoking cessation interventions among patients visiting a dental institute in Bangalore : A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Reduced Fagaerstorm value and reduced carbonmonoxide meter levels in lungs of smokers
Study Overview
Brief Summary
Tobacco uses and addiction have existed for centuries and, there surely was resultant death and disease . Evaluations indicate cigarette smoking causes the death of approximately five million people worldwide every year . A decrease in the prevalence of tobacco consumption can be effectively done through a prolonged approach called tobacco cessation, which includes various methods like pharmacological and non-pharmacological methods. One such non-pharmacological approach is Motivational Interviewing. Motivational interviewing is a type of counselling that can be used to help people to stop smoking. It aims to help people explore the reasons that they may feel unsure about quitting and find ways to make them feel more willing and able to stop smoking. The most commonly used pharmacological intervention in smoking cessation is nicotine replacement therapy (NRT), which is frequently available over the counter (OTC). It allows the absorption of nicotine through the buccal mucosa and reduces the motivation to consume tobacco and, the physiological and psychomotor withdrawal symptoms through the delivery of nicotine. A randomized clinical trial is to be conducted among 18 – 50 year smokers using a smoking form of tobacco products at Tobacco cessation cell in a dental institute in Bangalore. This randomized clinical trial is conducted to assess the effectiveness of three different smoking tobacco cessation interventions by assessing the reduction of carbon monoxide levels in smokers over three months.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Outpatients visiting hospital wit smoking habit
- •Fagerstrom score of more than 6
- •Patients willing to quit tobacco.
Exclusion Criteria
- •Patients having terminal illness/Any other medical illness.
- •Patients using smokeless type of tobacco
- •Pregnancy
- •Patients under psychiatric care
- •Previous history of alcohol or drug abuse
- •History of hypersensitive reactions toward nicotine or Menthol
- •Patients who were not willing to quit tobacco
- •Patients who were not willing to take part in the study.
- •Patients having TMJ dysfunction.
- •Patients wearing dentures.
Outcomes
Primary Outcomes
Reduced Fagaerstorm value and reduced carbonmonoxide meter levels in lungs of smokers
Time Frame: baseline, 2 weeks after the quit date, 4weeks after the quit date, 6weeks after the quit date, 8 weeks after the quit date, 10 weeks after the quit date, 12 weeks after the quit date
Secondary Outcomes
- overall reduction in smoking leading to healthier adn quality improved life(in period of three months)
Investigators
Dr Anagha Reji
Krishnadevaraya College of Dental Science & Hospital
