RCT on the Effectiveness of Quitting Smoking with Electronic Nicotine Delivery Systems

A randomised control trial of the effectiveness and experience of adults quitting smoking while using Electronic Nicotine Delivery Systems(ENDS) and Nicotine replacement therapy (NRT) and changes that may be seen in their periodontitis status in Newcastle.

Research summary

Despite knowing the detrimental effects of tobacco use, people still keep using it. It continues to kill more than 70000 people every year and around 1900 die from oral cancer in the United Kingdom (ONS, 2013). Effects are seen in the oral cavity; the most serious disease being oral cancer. The reasons for tobacco use are many but the main reason is its addictive nature which is mainly contributed by the nicotine in the tobacco (Public Health England, 2017).

Electronic Nicotine Delivery Systems (ENDS) heat a solution to create an aerosol that contains nicotine. It may possibly have higher and more concentrated form of nicotine which will help a person’s desire for the intake of nicotine to be fulfilled. This study is to see how beneficial will it be in using an ENDS device in quitting to smoke, in regard to the medically approved nicotine replacement therapy (NRT) products (Public Health England, 2017).

Patients from ten clinics from newcastle from the age of 18 and above will be recruited, who are current smokers and are willing to quit. The clinics will be cluster randomised. There will be an even number of patients in both control and intervention groups. They will be given advice on quitting smoking and take consent and then do an eligibility evaluation of the candidates. They will be handed smoking habit-breaking kits which will have either an ENDS device or an NRT product.

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Background

Tobacco usage is quite discouraged worldwide, the reason being it is quite harmful to the human body. A known fact is that tobacco consumption cause at least 50 different diseases , including various types of cancers, ischemic heart disease, strokes and chronic lung disease. Smoking associated disease therefore causes significant reduction of quality of life and DALY(s) as well as significant impact on the psychological and financial status of the ill individual and their family. Smoking increases the risk of oral diseases, such as  periodontal disease and  oral cancer. Periodontal disease is an inflammatory condition affecting the tissues surrounding the teeth(public health england 2017). Smoking is a common risk factor of many diseases (Sheiham , Watt 2000). Apart from the individual health impacts, smoking also affects a person’s financial status, social support, employment and housing opportunity. Growing up in a smoker’s family not only exposed to second-hand smoking but also potentially increase the chance of smoking in the future(Rozi, Mahmud, Lancaster 2015). Smoking has a  financial burden on the society, which are health services to deal with the smoking associated NCDs, smoking cessation programmed, reduction of manpower, house fires, waste and pollution caused by smokingPublic Health England (2019) .

Most people who smoke, start at a young age under mostly being burdened by peer pressure and not by their own will. It is 6 times more like for a person to start smoking if their friends smoke. In the United Kingdom(Rozi, Mahmud, Lancaster 2015), smoking is quite prevalent, even though it is widely known to cause harm to human body.14.7% adult of adults smoked in 2018 (7.2 million). in 2018, around 58% of those smokers, aged 16 and above, who currently smoked wanted to quit (ONS 2013).

The United Kingdom became a Party to the WHO Framework Convention on Tobacco Control on March 16, 2005. enabling the government to enforce strict laws on the tobacco industry. These included that the sale of tobacco products in stores be behind shutters so that they would not be seen by the consumer. The packaging of the product be limited to plain packing while  making it compulsory to give its ingredients. Advertisements and sponsorships were banned. Smoke free zones were made; meaning smoking was prohibited in public transport, indoor public places, and indoor workplaces, including work vehicles. Higher taxes were enforced on tobacco products(House of common parliamentary papers online 2019).

Emphasis on smoking cessation is done at a large scale but it does not produce the results which are wanted and the reason for that not happening are many. Two common reasons believed to be that a person is not able to achieve his/her desire is because tobacco contains nicotine which is a highly addictive substance and the withdrawal symptoms are the reason for one to carry on smoking (public health england 2007).

The most common symptoms include:

●      Having craving for cigarettes.

●      Feeling down or sad.

●      Having trouble sleeping.

●      Feeling irritable, on edge or grouchy.

●      Having trouble thinking clearly and concentrating.

●      Feeling hungrier or gaining weight.

●      Feeling restlessness and jumpy.

●      Having a slower heart rate.

(Managing Withdrawal 2019)

The second reason for a person not to be able to quit smoking is that they do not get the proper and professional help. Getting professional help will aid in helping an individual in quitting to smoke.

Number of methods have been proposed to deal with quitting smoking. For instance, certain medicines are available through prescriptions and nicotine replacement therapy has also proven to have a high success rate of 55%. Though it does have some side effects such as skin irritation from nicotine patches and throat irritation due to nasal sprays.

Another alternative which has come up in recent is Electronic Nicotine Delivery Systems (ENDS) which heats a solution to create an aerosol containing nicotine. It is more commonly termed as e-cigarettes. ENDS have turned into a major alternative for people who want to quit smoking, as it mimics the action of a person to be smoking a cigarette. A study found that ENDSs were more effective than NRT in smoking cessation when accompanied by support (Hajek et al. 2019). However, there are concerns about its safety and its evidence of effectiveness is yet to be established.

Smoking can be difficult to quit as it is quite addictive as earlier stated due to the presence of nicotine but the habit developed by the smoker itself is also a very difficult thing to stop. So, a comparison of how NRT and ENDS help smokers quit is needed with the added check of which is a healthier option in regard to oral cavity.

Research Question and Objectives

Research question

Can the use of an Electronic Nicotine Delivery Systems (ENDS) be more effective in a person to quit smoking and how will it be affecting the periodontal status of the person?

Objectives

• To carry out a cluster randomised control trial to test the difference in outcomes experienced between Electronic Nicotine Delivery Systems (ENDS) being the intervention group and Nicotine replacement therapy (NRT) product being the control group.
• To provide recommendation and supply of ENDS and NRT in primary dental setting.
• To compare the percentages of samples who successfully stopped smoking in each group (primary outcome).
• To investigate the oral health changes in regard to periodontal pocket depth of the percentage of number of teeth with periodontal pocket depth 6mm or above before and after (secondary outcome).
• To quantitatively compare the feeling and perceived experience outcomes in each group via questionnaire (secondary outcome).

Research plan

Design

The intervention will be carried out using randomized control trial to compare the effectiveness between 2 different methods of stopping smoking in primary dental service setting.  These 2 ways are NRT and ENDS which are the control and test group respectively. Randomization will be carried out by an independent clerk by a computer-generated list to avoid selection bias.  This will be followed by allocation concealment using sealed white non-transparent envelopes.

The periodontal assessment that is going to be used in this study will the Periodontal Pocket Depth (PPD). Training will be provided to the dentists who agreed to participate in this research. All the dentists will be registered with the GDC and they should be capable to carry out full mouth pocket chart. However, pocket depth measurements are known to have consistency issue. The measurements rely on the probe used, pressure used, density of periodontal tissue and angulation of the probe. The dental team will be invited for a briefing session to ensure uniform interpretation, understanding and application of the protocol and the criteria to be used. The aim of the training is to ensure each examiner is working to a uniform standard and minimize variation between examinations. This will be done training the team and ensuring that all of them grade everything in an exact similar manner and the benchmark that has set up for them they follow. For this dental team, they shall be calibrated on assessing of periodontal assessment as it is inclusion criteria for the candidates. As well as the periodontal assessment will be later on used to evaluate the health changes of the oral cavity.

Target population

The candidates will be chosen from NHS clinics in Newcastle England, as it is one of the most deprived areas in Great Britain, where household income growth is falling behind, as well as aggregate household total wealth by region is the lowest in the north-east. Where a large portion of adult’s smoke, according to the adult dental health survey that was a third of adult’s smoke in the north-east region. Being so much more deprived and having more number of smokers might link to having the greatest number of registered lung cancer cases in 2015-17 (117.8 per 100,000). This is significantly higher than the national average (76.8 per 100,000). As well having reported to the highest prevalence of 12% of the population having pocket depth 6mm or more. The prevalence is among the highest in Great Britain. These are alarming for a developed country to have such a huge contrast.

Before the trial starts, ethical approval application will be sent to the Research Ethics Committees as the research will involve NHS primary care setting. This procedure can be time-consuming and therefore will be the first priority of this study.

Two staged randomizations will be carried out after ethical approval. An invitation letter will be sent to every NHS dental clinic in Newcastle. Among those that agree to participate, 5 clinics will be randomly selected. This will be done by drawing from a hat. After obtaining consent to obtain patient records, the list of candidates will be made through the clinics, patient list of who are listed in the medical records as smokers and in the dental records of having periodontitis. They will be given a call primarily to ask them that if they would want to join a study in which they will benefit from by getting help to quit smoking. If they agree that they would like to join, they would be sent a formal document in their post which they will bring along with the invitation to an ice breaker included in the document. The ice breaker will be held for the ones who would want to join  on 15th March 2020, where all the candidates would be invited to get orientation about the trial. There they will be given smoking cessation advice and told what would happen if they consented for the trial with all advantages as well as disadvantages. After consenting to the trial, they will be evaluated for eligibility during 1st of May 2020 to 15th of May 2020 by the dental team who would have been calibrated to measure all the candidates with the same precision. The dental team will check their oral cavities and note down their PPD which will also be used as the baseline measurement of the periodontal outcome and for the eligibility assessment. 20 eligible participants will be randomly selected from each participating clinic. The candidates will then be allocated into the test and control group randomly. This is carried out by a computer-generated software to prevent the results from being altered to anyone’s preference. A number will be given to each participant to enable blinding of the analyzer.

Eligibility Criteria

The ones opting to be a part of the trial will be undergoing examination in which their health will be evaluated and if they are fit for the trial as well their oral health will be checked in which their pocket depth will be checked.

The inclusion criteria for the eligibility of the trial will be:

●      Smokers who want to quit.

●      Over 18 years of age and having the capacity to consent

●      Having periodontal pocket depth of 6mm or above on any teeth.

The exclusion criteria for the trial will include:

● Any chronic illness.

●Medically contraindicatory to NRT and/or ENDS: women who are pregnant or breastfeeding, kidney problem, people with epilepsy, bipolar disorder or eating disorders.

● Non consent

After getting screened, the candidates will be asked to fill in a questionnaire, which will enable us to evaluate the reasons why they want to quit and how their smoking habits were prior to entering the trial. Asked to sign a consent form, from there things will move forward.

Intervention

A total of a hundred candidates will be selected from chosen ten clinics. Each clinic forming a group of ten candidates with even ratio of 1:1 in contrast to control and test groups. After the sampling and eligibility of the candidates have been done,the final list of the candidates to whom the advice on smoking cessation was given will be compiled.  For the selected candidates, all will get the intervention on the 1st of June 2020, a different smoking cessation kit will be given to each candidate respectively. The kit for the control group contains nicotine patches and that for test group contains an ENDS (electronic nicotine delivery system) device. The supply of these nicotine products will be sufficient for 12 weeks. Each pack also contains a detail instructions and precautions of these products. These instructions and precautions will also be given to the candidates verbally. The intervention will be carried out by the research staff and keep away from the dentists to ensure the examiners are blinded. Also, as mentioned above the allocations will be concealed in an envelope for each candidate. This envelope should only be opened by the intervention providers just before giving out the smoking cessation kits. In addition, the participants are instructed not to disclose which group they belong to the dentists. In addition, the participants should avoid indicating which smoking cessation method they used in the questionnaire. The candidates will be contacted by calling them and confirming if they are continuing the trial.

Outcome measures

During recruitment, the baseline periodontal examinations were carried out by the dentists and a questionnaire was completely by each candidate. The questionnaire is the same for both groups and the dentists will be trained and blinded to minimize the risk of bias. The PPD measurements are carried with the graduated Williams periodontal probes. Full month PPD charting will be carried by the dentists and recorded by their dental assistants. Only the PPD chart and the respective participant’s number will be submitted to the research team to avoid breaching of personal confidentiality.

Follow-up data collection will be carried out via filling up of a questionnaire by each candidate. The follow-up questionnaire will be repeated at different times during the trial. After 12 weeks the trial would have been completed the candidates by the 31st of august 2020.

Candidates will be recalled to their respective clinics during the 1st of September 2020 to 15th of September 2020. Where they will again get an oral examination. The dental team will check their oral cavity and note down their PPD. The whole trial will take 14 weeks period from the time on primary examination to the last examination after the control and intervention have been used to aid in quitting and the final examination.Where they will again get an oral examination. The dental team will check their oral cavity and note down their PPD.

The primary outcome of this study is the success rate of stop smoking in each group.  At the end, each candidate will be asked to fill in a questionnaire to find out if they have quit smoking successfully. Their answers also indicate how they felt during the time of the trial and what was that made them help in not quitting from smoking and not quitting.

Secondly, periodontal examination will be carried out to evaluate how the oral health of different groups  changed during this trial and we would deduce that which product may be better to use in regard for better oral health.

The feedback of the candidates of how the intervention and control group benefited them in quitting smoking. They will be asked to fill in the questionnaire at the end of the trial as well a questionnaire will be sent to them once after three months and second after the six months of the end of the trial asking if they have abstained from smoking.

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Appendix

Participant ID: __________

Baseline questionnaire

To be completed at the beginning of the study

Participant ID: ________

Follow-up questionnaire

References

●        The Office of National Statistics (2013). Cancer Registration Statistics, England. 2011. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/2015-07-10#cancer-registration-datacollection-in-england

●        public health england (2007)Department of Health, Smokefree and smiling: helping dental patients to quit tobacco, 2007, The Stationery Office: London.

●        Lung cancer registrations,( 2015-17 )(Local Tobacco Control Profiles website)

●        public health england (2009)Delivering Better Oral Health: An evidence-based toolkit for prevention (Second Edition), 2009, The Stationery Office: London.

●        Johnson, N. and C. Bain, Tobacco and oral disease. British Dental Journal, 2000. 189(4): p. 200-206.

●        Adult Dental Health Survey, 2009:The Health and Social Care Information Centre,London

●        public health england (2014 ) ‘Smokefree and smiling Helping dental patients to quit tobacco’, , (2nd edition), pp. .

●        Sheiham A, Watt RG. The common risk factor approach: a rational basis for promoting oral health. Community Dent Oral Epidemiol. 2000;28:399–406.

●        Jill M. Loewen, RDA, MS; Erin E. Relich, RDH, MSA (2019) ‘Electronic Nicotine Delivery Systems: Current trends and patient education opportunities for dental hygienists’, The Journal of Dental Hygiene, 93(1), pp. .

●        Public Health England (2017) Delivering better oral health: an evidence-based toolkit for  prevention

●        Public Health England (2019) Health matters: stopping smoking – what works?, Available at: https://www.gov.uk/government/publications/health-matters-stopping-smoking-what-works/health-matters-stopping-smoking-what-works (Accessed: 25th august 2019).

●        () Managing Withdrawal, Available at: https://smokefree.gov/challenges-when-quitting/withdrawal/managing-withdrawal (Accessed: 25th august 2019).

●        S Rozi, S Mahmud, G Lancaster (2015) ‘Peer pressure and family smoking habits influence smoking uptake in school going male adolescents’, European Journal of Public Health, 25(3), pp. 456.

●        House of Commons parliamentary papers online (2019) Health and safety at work (tobacco smoking). A bill to amend the Health and Safety at Work Act 1974 so as to provide for the control of smoking in places of work; and for connected purposes., Available at: https://parlipapers-proquest-com.libproxy.ucl.ac.uk/parlipapers/result/pqpdocumentview?accountid=14511&groupid=96098&pgId=a0fdc379-b9e7-43c6-a790-a28ef4137c76#129(Accessed: 25th august 2019).