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Long-term follow-up of tobacco cessation intervention in a dental setting: A randomized trial

1 Department of Oral Medicine and Radiology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India
2 Department of Oral Medicine and Radiology, RV dental College and Hospital, Bengaluru, Karnataka, India
3 Department of Community Medicine, M.S. Ramaiah Medical College, Bengaluru, Karnataka, India
4 Department of Public Health Dentistry, V S Dental College and Hospital, Bengaluru, Karnataka, India

Date of Submission14-Aug-2020
Date of Decision28-Sep-2020
Date of Acceptance21-Dec-2020
Date of Web Publication17-Jul-2021

Correspondence Address:
S Sujatha,
Department of Oral Medicine and Radiology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bengaluru, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jcrt.JCRT_1029_20

 > Abstract 

Aims and Objectives: Tobacco dependence is widely prevalent and a harmful chronic disorder. Achieving long-term tobacco abstinence is an important public health goal. This study aims to assess the long-term effectiveness of moderate-intensity treatment for tobacco cessation in the dental clinic setting.
Materials and Methods: Out of 1206 subjects registered to the Tobacco cessation clinic (TCC) during this time period, only 999 of them completed the 1-year follow-up period. The mean age was 45.9 ± 9 years. Six hundred and three (60.3%) of these subjects were male and 396 (39.6%) of them were females. Five hundred and fifty-eight (55.8%) used smoking tobacco and 441 (44.1%) used smokeless tobacco. Patients received tailored behavioral counseling, educational material, and pharmacotherapy consisting of nicotine replacement therapy (NRT) and\or NON-NRT. Patients were monitored by phone or clinic visits for 11 months.
Results: Outcomes assessed were complete abstinence, harm reduction (>50% reduction), no change and lost to follow-up. At the end of 12 months the tobacco quit rate was180 (18%), tobacco reduction >50% was 342 (34.2%), no change 415 (41.5%) and relapse 62 (6.2%).
Conclusions: Our study has identified adequate quit-rates in a cohort of dental patients attending a hospital-based TCC.

Keywords: Behavioral counseling, long term abstinence, pharmacotherapy dental clinic, tobacco cessation

How to cite this URL:
Sujatha S, Iyengar A, Pruthvish S, Prashanth R. Long-term follow-up of tobacco cessation intervention in a dental setting: A randomized trial. J Can Res Ther [Epub ahead of print] [cited 2022 Jun 25]. Available from: https://www.cancerjournal.net/preprintarticle.asp?id=321708

 > Introduction Top

India has a huge burden of tobacco-related morbidity, disability, and mortality. India's tobacco problem is very complex with majority of people using a variety of smoking forms and an array of smokeless tobacco (ST) products.[1] ST has grown at an alarming rate in India, about one-fifth of the world's total production and cultivation is done by India. Furthermore, a greater concern is the growing prevalence of dual tobacco consumption among the population and forming a tobacco quit strategy.[2] The tobacco problem in India is very complex and extensive, and there are inadequate resources to tackle these problems. Interventions for substance abuse are largely limited to specialized de-addiction centers and mostly to tertiary intervention for those with established late-stage problems. While some of the tobacco users may quit without assistance, a large fraction of them require assistance with cessation, and for this group of users, tobacco cessation treatment should be provided. Among the 70% of nicotine dependent participants reporting that they want to quit, annually only 4%–6% succeed. Unassisted tobacco cessation is very low unlike in the West.[3] Tobacco cessation is thus an increasingly relevant intervention in clinical settings in developing countries like India.

Although dental office-based tobacco-use cessation interventions are efficacious, adoption into practice has been slow. The most significant barrier remains the lack of education on tobacco cessation activities and lack of time among the others.[4] The dental patient more so the current tobacco user visits the dental clinic multiple times per year, receiving either treatment or preventive services and these visits can be utilized to offer tobacco cessation advice and counseling. With consideration to the oral health effects associated with chronic tobacco use, the dental visit provides a “teachable moment” during which the dental team can relate oral health and systemic health to tobacco use and provide evidence-based brief interventions.[5] Here, we present the long-term tobacco cessation treatment outcome of out-patients in a dental hospital, Bangalore, India.

 > Materials and Methods Top

The study was carried out at the Tobacco Cessation Clinic (TCC) located within the Oral Medicine Department, Faculty of Dental Sciences, Bangalore. The study was approved by the Institutional Review Board and all participants provided informed consent. The study participants were dental patients using tobacco in either smoking\smokeless form for more than 6 months, at least twice/day reporting to the dental OPD. Individuals currently using Nicotine replacement therapy (NRT) or Non-NRT therapy for tobacco cessation, pregnant and lactating women, recent H\O of myocardial infarction, gastric ulcer were excluded from the study. The baseline characteristics of 1206 patients registered under the TCC during the period August 2017 to August 2019 were characterized. About 95% of the patients were subjects seeking dental treatment in the hospital; only 5% were “walk-in” patients attempting to quit tobacco use.

A structured validated questionnaire was administered to all registered to obtain information on sociodemographic characteristics and tobacco-use details such as age at initiation, past quit attempts, current use per day, and information on self-use of other addictive substances (e.g., alcohol), family history of tobacco use, presence of medical comorbidities was also documented among smokers and ST users. All patients were interviewed and assessed for willingness to quit. Moderate intervention - 3Es and 6As model, an adaptation of WHO 5A model consisting of behavioral counseling and pharmacologic therapy was provided for all patients (3Es and 6As – Every patient at Every visit tobacco use documentation was Ensured and 6As was followed-Ask, Advise, Associate, Assess, Assist and Arrange) [Figure 1]. It comprised of 30–40 min individual sessions. Counseling was carried out by the faculty members and postgraduate students of the department, who were trained in tobacco cessation support methods and had also received additional training in the specific programs used in the study. Printed leaflets on ill effects of tobacco use, benefits of quitting tobacco, and coping strategies for tobacco craving and withdrawal symptoms were given to all subjects. Tobacco dependency was assessed by both the Fagerström Test for Nicotine Dependence (FTND)/FTND-ST (Fagerstrom test for nicotine dependency questionnaire) and salivary cotinine levels. A commercially available Enzyme-Linked Immunosorbent Assay kit, Calbiotech Inc., USA, was used as a biological monitor to assess the tobacco exposure using saliva specimens from participants. All patients were categorized into low, moderate, and high dependents based on the assessment. It was followed by oral examination, and then moderate tobacco intervention was offered, which included personalized counseling, pharmacotherapy, and long-term follow-up.
Figure 1: 3Es and 6As tobacco cessation model for moderate intervention (an adaptation of the WHO 5A model)

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First-line pharmacotherapy, NRT (nicotine gums and patches), bupropion sustained release, and varenicline were offered as pharmacotherapies. Long-term follow-up for 11 months was arranged to assess the long-term tobacco abstinence. The first follow-up contact was set during the 1st week, second follow-up contact at the end of the 1st month, 3rd, 6th, and 11th month from the delivery of the intervention (5 contact sessions). It was strongly recommended that the tobacco user give up tobacco completely in one go on the quit date. If the patient visited with an acute problem (e.g., painful teeth) then it was addressed first, and then the advice was given at subsequent visits linking the disease to tobacco use. Specific interventions were tailored as per the person's level of tobacco addiction and preference of therapy. Tobacco abstinence\reduction was assessed at each visit through interview and FTND scale. Salivary cotinine levels were assessed for all participants at the baseline and on quitting only. After three unsuccessful attempts to contact the subject by telephone or E-mail for follow-up within the stipulated period, the subject was considered as a dropout. Participants who quit tobacco were congratulated and warned about relapse. In case of relapse, the patient was asked to engage in renewed quit attempts, and in the event of co-morbidities, they were referred to a specialist at the De-addiction center. If a patient was not ready or willing to consider quit, they were motivated to consider with the “5 R's” model: Relevance, Risks, Rewards, Roadblocks, and Repetition.

Outcome measures

  • Quit (12-month continuous abstinence) as: “not one puff of smoke/use of ST during the past 12 months (365 days)''
  • Harm reduction (>50% reduction) - Reduction in tobacco use by 50% or more
  • No change - No change in tobacco use status
  • Lost to follow-up - Failure to establish contact by telephone/email for three unsuccessful attempts.

Data were analyzed using SPSS PC, version 13.0.(IBM), Descriptive statistics along with inferential testing using Chi square tests were used for the outcomes of interest; significance was set at a P < 0.05. Parameters with P < 0.10 were included in a multivariate logistic regression analysis model for quitting.

 > Results Top

One Thousand two hundred and six tobacco users were enrolled for the study of which 207 (17%) subjects were lost to follow-up. Of the 999 subjects, 603 (60.3%) were male and 396 (39.6%) of them were females. Five hundred and fifty-nine (55.9%) used smoking tobacco (cigarettes, bidis) and 440 (44%) used ST i.e., commercial ST products such as gutka and pan masala and traditional paan with loose tobacco. The mean age of the subjects was 45.9 ± 9 years. Most of the patients were married (72%) and predominantly urban (81%). Thirty-six percent were degree holders, 45% had completed at least 8 years of schooling and 19% were illiterate. The mean age at initiation was 18.9 (±3.6) years. About 54% of tobacco-users reported a family member using tobacco and 44.1% reported concomitant alcohol use. About 42.4% of patients had attempted quitting earlier. Majority of the subjects were daily users of tobacco, with 17.2% having low level of addiction, 50.4% medium level of addiction, and 32.3% high level of addiction (P = 0.001). There was a strong correlation between FTND scores and salivary cotinine levels among tobacco users. Commonly documented medical co-morbidities included: chronic respiratory disease, hypertension, diabetes, tuberculosis, myocardial infarction, cancers, and stroke. Among the oral health concerns, the patients visit to the dental college included dental caries, gingivitis, periodontitis, abscess formation, oral mucosal lesions, implant failure, etc., Postintervention the tobacco use status was 18% (180) quit, 34.2% (342) reduced tobacco use by >50%, there was no change in tobacco use status in 41.5% (415) and relapse was seen in 6.3% (63). Significantly higher proportion of males than females quit tobacco 15.3% versus 2.7%, P = 0.000 [Table 1] and quit rate was highest among participants with low level of addiction at 10.8% compared to medium at 6.5% and 0.7% among the high level of addiction group (P = 0.043) [Table 2]. 14.4% of the smokers and 3.6% of ST users quit (P = 0.00) [Table 3]. The time of quitting was found to be highest during the 3rd to 6th month follow-up [Table 4]. Regression analysis showed gender, occupation, willingness to quit and level of nicotine addiction were strong predictors for quitting tobacco use in the present study [Table 5].
Table 1: Distribution of study subjects related to tobacco use status postintervention based on gender

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Table 2: Distribution of study subjects related to tobacco use status postintervention based on the level of addiction

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Table 3: Distribution of study subjects related to tobacco use status postintervention based on the type of tobacco used

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Table 4: Distribution of study subjects related to the time of quitting

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Table 5: Regression analysis for independent factors determining quitting

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 > Discussion Top

India has a diverse population with the amalgamation of different cultures, religions, and practices. Earlier tobacco was considered as taboo, but with the advent of the 21st century and commercialization of tobacco, it has been prevalent among males and females.[2] People smoke more tobacco in urban areas as compared with rural areas. With increase in age, tobacco prevalence increases, and in India, males use more tobacco as compared with females.[6] In the present study, the male to female distribution was 60:40 with 603 (60.3%) men and 396 (39.6%) females. The prevalence of tobacco use among men has been reported to be high in most parts of the country generally exceeding 50%.[7] According to GATS India, 2016–2017, 19.0% of men, 2.0% of women, and 10.7% (99.5 million) of all adults currently smoke tobacco and 29.6% of men, 12.8% of women and 21.4% (199.4 million) of all adults currently use ST.[8] The use of ST among males is higher than females; in contrast, smoking has a sharp difference between the two genders. Smoking by women in India is still socially unacceptable, but ST use is common and on the rise.[2]

In the present study, a total of 18% quit tobacco use, 34.2% showed a reduction in tobacco use by >50%, in 41.5% there was no change in the tobacco habit and there was a relapse in 6.2% of the participants. The quit rate of 18%, is significantly higher compared to a community-based group intervention for tobacco cessation in rural areas of Tamil Nadu State where a quit rate of 12.5% and harm reduction of 21.7% in the intervention group at 2-month follow-up. In another study, smoking cessation intervention among patients attending primary health centers' in Kerala State, a quit rate of 16% in the minimal intervention group and 21% in the augmented intervention group at 3-month follow-up was reported.[9] The quit rates reported by TCCs across India, setup by GOI is about 14% and 22% reported harm reduction at the end of the 6-week follow-up.[10] In a study by Mony et al., among a cohort of patients attending a TCC located within the chest medicine out-patient clinic in Bangalore city, reported 5% quit rate at 24-month follow-up compared to 50% quit rate reported among chronic obstructive pulmonary disease patients in a developed country.[11] Low success rates are common in a nonvoluntary cessation program. Similarly in the present study low quit rates were observed among participants with low intention and willingness to quit. Other possible reasons could be that moderate tobacco intervention session, involving stage-matched and risk communication might not be sufficiently intensive to trigger chronic or “hardcore” tobacco users and those who had many past failures to quit. Several studies report that hard-core tobacco users are less likely to be affected by tobacco control interventions or policies.[12]

In the present study, it was found that a significantly higher proportion of males than females quit tobacco 15.3% versus 2.7%, P = 0.000 [Table 1]. Women were less successful than men at quitting tobacco which is consistent with the findings of other studies.[2],[13] They appear to have higher behavioral and lower nicotine dependence than men, thus greater emphasis on behavioral compensation for women and nicotine replacement for men should be tailored to increase their chances of abstinence. Conflicting results of gender for tobacco cessation were found, where some studies found that male smokers were more likely to be successful quitters whereas other studies found no association between gender and successful quitting. Among women, biopsychosocial factors such as pregnancy, fear of weight gain, added difficulty to cope with a negative mood associated with abstinence, depression, and the need for social support appear to be associated with tobacco cessation, maintenance, or relapse.[14]

In the present study, the quit rate was highest among the younger and middle age groups, 5.8% among 18–24 years, 10.9% among 25–44 years age group as compared to 1.3% in 45–65 years and none above 64 years of age (P = 0.005). These findings are consistent with the study by Hammond. Young adults were more likely than older adults to quit tobacco successfully. This could be explained partly by more widespread interest in quitting, lower levels of nicotine dependence, and higher prevalence of smoke-free homes.[15] Based on the duration of tobacco use the quit rate was highest among 1–10 years of tobacco use as compared to tobacco use more than 10 years (P = 0.043).In the present study, the quit rate was highest among the married participants at 12.2% as compared to unmarried at 5.8% and none in the widower group (P = 0.139). Marital relationship is regarded as one of the most important factors that influence health behaviors. This may be explained by the direct and indirect social control within the couple, behavioral diffusion, and sharing of the same environment.[16] The quit rate was highest among participants who were obviously ready to quit at 15.5% as compared to moderately ready and not ready to quit. Based on the levels of addiction quit rate was highest among participants who had a low level of addiction at 10.8% as compared to the medium level of addiction at 6.5% and 0.7% among the high level of addiction group (P = 0.043). The tobacco quit rate was higher among subjects who were willing to quit than others who were not.

In the current study, the quit rate was 14.4% among the literate and educated as compared to the illiterates (P = 0.163). In India, tobacco consumption is more prevalent among the disadvantaged group and they face higher exposure of tobacco harms. People with lower socioeconomic status have a more inclination toward tobacco consumption and quit attempts are less likely to be successful mainly due to reduced community support for quitting, strong addiction and less motivation to quit, more likely not to complete pharmaceutical and behavioral intervention for tobacco quitting, psychological problems such as lack of self-efficacy, and tobacco industry marketing.[1],[2] A study on smoking prevalence among men in Chennai, showed that the highest rate was found among the illiterate population with 64%.[17] In another Bangalore-based study, most of the tobacco users were laborers, daily wagers, maids, and drivers with more than 67% been illiterate. The present study findings are consistent with several studies which have shown that tobacco use is higher among the less educated or illiterate, and the poor and marginalized groups.[18] Education is a potential predictor of tobacco cessation, a higher level of education raises the odds of cessation as it impacts the general health knowledge, attitude, and beliefs. Hence, targeted policies and interventions should be focused. Similarly, occupation is also an important determinant of tobacco cessation. In the 2000 National Health Interview Survey, among the blue-collar workers, tobacco use prevalence was more than double than those of white-collar workers.[19]

In the present study, a total of 55.9% (559) subjects used the smoked form of tobacco and 44% (440) used ST. One hundred percent of the smokers were men and among ST users 9% (44) were men and 90.9% were women. Among smokers, 72% (402) used cigarettes, and 28% (157) used beedis, among ST users, 81% (356) used commercial tobacco products such as gutka and khani and 19% (84) used traditional pan, i.e., betel leaf, areca nut, lime with tobacco. 14.4% of the smokers quit tobacco whereas only 3.6% of ST users quit (P = 0.00) [Table 3]. The quit rate for smoking tobacco was four times higher than for ST. There was a significant association between the type of tobacco used and quit rate. Depending on the type of tobacco product used, the quit rate was highest among cigarette users at 12.2%, followed by commercial ST product users at 3.1%, beedi users at 2.5%, and traditional pan users at 0.4%. In many ways, quitting ST is a lot like quitting smoking. Both tobacco products contain nicotine, and both involve the physical, mental, and emotional parts of addiction. But people find it more difficult to quit ST and there is often a strong need to have something in the mouth (an oral substitute) to take the place of the chew or quid. In the present study, nicotine gums were used to aid cessation, and most ST users found nicotine gum to be a good chewing alternative that could address the issues of oral gratification, during tobacco abstinence. Among the urban smokers, smoking was never allowed in the smoker's house probably because of knowledge about the harmful effects of secondhand smoke which might have also contributed to higher likelihood of quitting. A similar study observed a significantly higher likelihood of having smoke-free homes compared to rural residents among the Bangladeshi population.[20],[21] In contrast in a Swedish study the quit rate for ST was three times higher than for smoking tobacco, and ST was promoted as a safer alternative to cigarettes.[22]

Given the various types of ST used in the Indian subcontinent and its increasing popularity in children and adults alike, it is of immense significance that the public be made aware of ST use as a major risk factor for oral cancer. Most of the tobacco control initiatives around the world have been aimed toward cessation of smoking, where the main strategy to decrease smoking prevalence is the high amount of taxes levied on smoking products. Although this might be productive for smoking cessation, this strategy may facilitate an unintentional push toward ST use and increasing prevalence because ST is comparatively cheaper. Furthermore, big tobacco companies revert to manufacturing ST products and advertising them as less harmful than smoking.[23] All these scenarios may potentially lead to a surge in the use of ST products and subsequent increased risks for oral cancer. The government and general public should be made aware of the potential dangers related to such approaches and ST cessation should be viewed seriously.

From baseline to 11-months follow-up, there was a significant increase in the proportion of subjects who quit. Quit rates were found to be highest during the 3rd–6th month follow-up [Table 4]. Gender, occupation, willingness to quit, and level of nicotine addiction were strong predictors for quitting tobacco use in the present study [Table 5].

In the present study, 34.2% of the participants reported tobacco use reduction by 50% which is an encouraging indication. Tobacco reduction, defined herein as an overall decrease in tobacco use, is a strategy used to moderate the health and financial effects of tobacco use and ease toward complete cessation.[24] Several studies have found that reduction among smokers who are not trying to quit is common and often leads to abstinence. Because reduction often preceded or followed cessation, it might serve as a signal that tobacco users are motivated to change, even after a failed quit attempt.[24],[25] Tobacco reduction may be a more attainable goal compared to complete cessation and is more desirable than regular use, and once achieved, it may encourage further efforts to achieve cessation. Although tobacco reduction is a promising intervention, the benefits are only observed when it leads to permanent cessation.

Resumption of tobacco use within a period of 11 months was considered as relapse in our study. Our results showed that the rate of tobacco relapse was 6.2% which decreased over time consistent with previous studies. In our study, it was found that relapse was slightly more among women as compared to men similar to the findings of the other studies.[26] Individuals with relapse were motivated to attempt tobacco cessation again. Many try to quit repeatedly before they succeed, with some relapse occurring even after a lengthy period of abstinence.

Although 1206 patients were enrolled initially into the study, only 999 continued till the end of completing the protocol, underlining the high attrition rate at 17%, which may be due to the difficulty in quitting, long follow-up period, lack of motivation, and withdrawal symptoms. High drop-out rates are a common finding in tobacco cessation studies. Medication cost also appears to influence both patient utilization of tobacco cessation interventions and abstinence. Direct associations exist between adherence to medication therapy and treatment outcomes. One fifth of tobacco users who receive medication for the treatment of tobacco dependence fail to fill their prescriptions.[27] To maximize drug efficacy, patients need to adhere to dosing guidelines. With this in mind, prescribers should choose appropriate treatments tailored to patient preferences, patient adherence, such as medication cost, dosing frequency, and the adverse effect profile. Patients should be educated about the rationale for treatment and possible side effects, and reinforce the importance of treatment adherence. Maintenance therapy is recommended as an effective strategy for relapse prevention in smokers who are initially unsuccessful at quitting. There is a direct relationship between the time spent on the implementation of protocols and how well patients adhere to them. Repeated consultation is important in reinforcing the necessity of quitting at every clinical visit. Tobacco cessation activities in a dental setting need to be upscaled, and the public better informed of the availability and relevance of such interventions to improve retention in tobacco cessation programs.

 > Conclusions Top

Our study has identified adequate long-term abstinence rates in a cohort of dental patients attending a hospital-based TCC. The dentist generally screens healthy patients on a regular and periodic basis which provides many opportunities for health screening, clinical and behavioral assessment, information, education, motivation, and long-term follow-up. While intensive therapy may not be in the realm of dentists but providing brief–moderate interventions and NRT holds plenty of promise and this intervention is relatively cost-effective because it is part of the existing health-care services which are used by the majority of tobacco users. If all dentists provided cessation services and were able to assist 10% of their tobacco-using patients to quit, the impact would be immense.

Strengths of the study

  • The study was conducted in people with diverse cultural background, tobacco habits, level of education, and economical status
  • The study also included ST users
  • There was a long-term follow-up to 11 months with periodic reinforcement through counseling
  • Nicotine addiction was assessed by both FTND scores and biochemical assessment (salivary cotinine levels), and tailored treatment was planned. Similarly, validation of abstinence was also assessed using FTND scores and salivary cotinine levels.

Limitation of the study

  • Less representation from rural areas.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

 > References Top

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  [Figure 1]

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]


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