Role of nicotine gum and behavioural counselling in quitting smokeless tobacco habit

Efficacy of nicotine gum for intervention of smokeless tobacco cessation in adults in a dental setting: A randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064840

Enrollment

100

Registered

2024-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: Nicotine gum: 2mg of nicotine gum will be provided to the participants for a period of 12 weeks. Control Intervention1: Behavioural Counselling: Behavioural counselling will be provided

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have a habit history of using smokeless tobacco (khaini or gutkha) >= 10 packets daily for at least 6 months 2. Patients who have not taken any NRT earlier for smokeless tobacco cessation 3. Patients who are ready to quit the habit of smoking and are willing to receive regular follow-ups

Exclusion criteria

Exclusion criteria: 1. Smokeless tobacco users with coexisting systemic illnesses 2. Pregnant and lactating mothers 3. Smokers and other smokeless tobacco users other than gutkha and khaini

Design outcomes

Primary

Measure	Time frame
Abstinence rateTimepoint: 3 and 6 months	—

Secondary

Measure	Time frame
Smokeless Tobacco Dependency Oral health status Quality of Life Withdrwal Symptoms Timepoint: Baseline, 3 and 6 months	—

Countries

India

Contacts

Public ContactDr Smitarani Priyadarshini

Institute of Dental Sciences

smitapriyadarshini@soa.ac.in8339999846

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026