Effectiveness of nicotine gum for intervention and role of behavior counselling for smokeless tobacco cessation in adults in a dental setting: A randomized control trial

Smokeless tobacco (SLT) cessation interventions remain limited despite significant oral health consequences. This study compared nicotine replacement therapy with behavioral intervention for SLT cessation in dental settings. A randomized controlled trial enrolled 100 adult SLT users (mean age 37.4 ± 15.5 years, 92% male) at dental clinics. Participants received either 2 mg nicotine gum ( n = 50) or Behavioural Intervention for Smokeless tobacco Cessation for Adults (BISCA) counseling ( n = 50) over 12 weeks. Primary outcomes included withdrawal symptoms (Minnesota Tobacco Withdrawal Scale) and biochemically verified abstinence. Follow-up extended to 6 months. Baseline characteristics were balanced between groups. Self-reported abstinence at 3 months was 74% vs. 68% ( p = 0.509), while biochemically verified abstinence at 6 months reached 46% vs. 40% ( p = 0.545). Both interventions were well-tolerated with minimal adverse events. Nicotine gum demonstrated significantly superior withdrawal symptom management: 90% vs. 34% achieved craving-free status ( p < 0.001), 98% vs. 54% were anxiety-free ( p < 0.001), and 100% vs. 82% experienced no sleep problems ( p = 0.020). The abstinence rates showed favorable trends, however, larger studies are needed to establish definitive cessation efficacy. Nicotine replacement therapy provided superior management of key withdrawal symptoms compared to behavioral intervention alone, particularly for craving, anxiety, and sleep disturbances. These findings support integrating pharmacological interventions into dental-based SLT cessation programs to improve patient outcomes and reduce tobacco-related oral health burden. Trial Registration No. and Date : CTRI/2024/03/064840 on 27 March 2024 with Clinical Trials Registry – India.