scholarly journals International Randomized Controlled Trial Evaluating Changes in Oral Health in Smokers after Switching to Combustion-Free Nicotine Delivery Systems: SMILE Study protocol

Author(s):  
Gianluca Conte ◽  
Sebastiano Antonio Pacino ◽  
Salvatore Urso ◽  
Pasquale Caponnetto ◽  
Francesca Benfatto ◽  
...  

ABSTRACTAlthough the well-known detrimental effects of conventional cigarette smoking on oral health, there are still lack of evidences about the impact of less harmful alternatives (such as electronic cigarettes or heat not burn products), especially in young smokers with clinical absence of signs of periodontitis.SMILE will be a prospective, multicenter, interventional, open label, randomized, controlled, three parallel-arms study assessing oral health parameters and teeth appearance of 18 months duration.This study aims to compare short- and long-term impact on oral health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers by objectively evaluating changes in gingival response, as a proxy for periodontal/gingival.The total number of participants in the study planned of the trial is 606 (505 regular smokers and 101 never-smokers).Regular smokers not intending to quit will be randomized in the ratio 1:4 either in continuing to smoke commercially manufactured conventional cigarettes (n = 101; Study Arm A) or switching to C-F NDS (n = 404; Study Arm B), never-smokers will be assigned in Arm C (n= 101).The primary outcome will be to assess and compare the percentage mean change in Modified Gingival Index (MGI) score between Baseline and 18 months follow-up between the Study Arms A and B.Secondary outcomes include the assessment of within- and between-group (Arm A, Arm B and Arm C) variations from baseline to 18 months follow-up of several endpoints, such as MGI, Tooth Stains Assessment, Dental Discolorations, Plaque Score Imaging, Oral Health Quality of Life (OHQOL) assessment and EuroQoL Visual Analog Scale (EQ VAS – QoL) assessment.Patient recruitment will start in January 2021 and enrolment is expected to be completed by June 2021.This will be the first study determining overall oral health impact of using CF-NDS in smokers without sign of periodontitis. Data from this study will provide valuable insights into the overall potential of C-F NDS to reduce the risk of periodontal diseases.

Author(s):  
Д.А. Еникеев ◽  
Л.Т. Идрисова ◽  
О.А. Еникеев ◽  
К.О. Кузнецов ◽  
Д.Р. Ахмадеева ◽  
...  

В статье представлены актуальные данные экспериментальных и клинических исследований по изучению влияния различных средств доставки никотина в организм курильщика. Проведён сравнительный анализ воздействия табачных сигарет, электронных средств доставки никотина и системы нагревания табака IQOS на показатели здоровья и развития организма человека, а также лабораторных животных. Показано, что, несмотря на громкие заявления производителей альтернативных средств доставки никотина о полной безвредности их устройств, результаты экспериментальных исследований обнаруживают в них не только известные канцерогены, но и новые потенциально опасные вещества, которые не содержатся в обычных сигаретах, и влияние которых на организм достаточно не изучено. На данный момент имеются все основания полагать, что употребление электронных сигарет и IQOS может приводить к заболеваниям нервной, кроветворной, иммунной, дыхательной систем, а также к развитию онкологических заболеваний. The article presents current results of experimental and clinical studies focusing on effects of various nicotine delivery systems. The authors conducted a comparative analysis of the impact of tobacco cigarettes, electronic nicotine delivery devices, and IQOS tobacco heating systems on the health and development of humans and laboratory animals. The review of recent literature has shown that, despite ambitious statements of the manufacturers about complete safety of their devices, experiments have demonstrated that they release not only well-known carcinogens but also new, potentially hazardous substances. These substances are not contained in ordinary cigarettes, and their effects on the body has not been sufficiently studied. Presently, it seems very likely that the use of electronic cigarettes and IQOS can lead to diseases of the nervous, hematopoietic, immune, and respiratory systems as well as to oncological diseases.


2019 ◽  
Vol 134 (5) ◽  
pp. 528-536 ◽  
Author(s):  
Robert McMillen ◽  
Jonathan D. Klein ◽  
Karen Wilson ◽  
Jonathan P. Winickoff ◽  
Susanne Tanski

Objectives: Any potential harm-reduction benefit of electronic cigarettes (e-cigarettes) could be offset by nonsmokers who initiate e-cigarette use and then smoke combustible cigarettes. We examined correlates of e-cigarette use at baseline with combustible cigarette smoking at 1-year follow-up among adult distant former combustible cigarette smokers (ie, quit smoking ≥5 years ago) and never smokers. Methods: The Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal study, surveyed 26 446 US adults during 2 waves: 2013-2014 (baseline) and 2014-2015 (1-year follow-up). Participants completed an audio computer-assisted interview in English or Spanish. We compared combustible cigarette smoking at 1-year follow-up by e-cigarette use at baseline among distant former combustible cigarette smokers and never smokers. Results: Distant former combustible cigarette smokers who reported e-cigarette past 30-day use (9.3%) and ever use (6.7%) were significantly more likely than those who had never used e-cigarettes (1.3%) to have relapsed to current combustible cigarette smoking at follow-up ( P < .001). Never smokers who reported e-cigarette past 30-day use (25.6%) and ever use (13.9%) were significantly more likely than those who had never used e-cigarettes (2.1%) to have initiated combustible cigarette smoking ( P < .001). Adults who reported past 30-day e-cigarette use (7.0%) and ever e-cigarette use (1.7%) were more likely than those who had never used e-cigarettes (0.3%) to have transitioned from never smokers to current combustible cigarette smokers ( P < .001). E-cigarette use predicted combustible cigarette smoking in multivariable analyses controlling for covariates. Conclusions: Policies and counseling should consider the increased risk for nonsmokers of future combustible cigarette smoking use as a result of using e-cigarettes and any potential harm-reduction benefits e-cigarettes might bring to current combustible cigarette smokers.


2021 ◽  
pp. 00976-2020
Author(s):  
Louise Adermark ◽  
Maria Rosaria Galanti ◽  
Charlotta Ryk ◽  
Hans Gilljam ◽  
Linnea Hedman

ObjectiveThe aim of this systematic review and meta-analysis was to assess the association between e-cigarette use and subsequent initiation or recurrence of cigarette smoking.Data sourcesA systematic literature search was finalised November 11, 2019 using PubMed incl. Medline, EMBASE, Cochrane Library, Scopus, PubMed Health, NICE evidence search, PROSPERO, CRD, and PsycInfo.Study selectionStudies were included if meeting the following criteria: reporting empirical results; longitudinal observational design with a minimum of 3 months of follow-up; including general population samples; allowing for the comparison between users and non-users of e-cigarettes. Studies rated as having high risk of bias were excluded. Studies were independently assessed by at least two authors. The procedures described by PRISMA were followed, and the quality of evidence was rated using GRADE.Data synthesisThirty longitudinal studies from 22 different cohorts assessing e-cigarette use among non- or never-smokers at baseline, and subsequent use of cigarette smoking at follow-up, were included in this review. A random-effects meta-analysis based on 89 076 participants showed a pooled unadjusted odds ratio (OR) of cigarette smoking among baseline non-smokers e-cigarette users compared with non-users of 4.68 (CI 3.64–6.02), while the adjusted OR was 3.37 (CI 2.68–4.24). These results were consistent irrespective of whether the outcome was measured as ever smoking or as past 30-day smoking. The evidence was graded as moderate.ConclusionsUse of e-cigarettes may predict the initiation or recurrence of cigarette smoking.


Toxics ◽  
2019 ◽  
Vol 7 (4) ◽  
pp. 61 ◽  
Author(s):  
Gozde Isik Andrikopoulos ◽  
Konstantinos Farsalinos ◽  
Konstantinos Poulas

The number and popularity of electronic nicotine delivery systems (ENDS) and especially e-cigarettes (e-cigs) have been increasing in the last decade. Although ENDS owe their popularity to excluding the harmful chemicals that are present in tobacco smoke, there is a debate whether they are safe, regulated, and as harmless as they are assumed to be and have potential unknown long-term effects. Involvement of cigarette smoking to the progression of periodontal diseases, other adverse oral health outcomes, and its detrimental effects to oral health are well-described. ENDS producer companies claim that these products can improve oral health by providing alternatives to smoking. However, the effect of e-cigs on oral health is not fully understood and is still debated among many scientists and clinicians. The number of studies addressing the potential toxic effect of ENDS or e-cig aerosol on oral cells is limited along with the clinical studies which are still preliminary, and their sample size is limited. The long-term effects of inhaled aerosols and the potential synergistic effect of the e-cigs components are not known. It is essential and of utmost importance to determine whether exposure to ENDS aerosol contributes to the progression of periodontal diseases and how it affects periodontal ligament and gingival cells which are believed to be its first targets. This review briefly summarizes the available evidence about the effects of e-cigs on periodontal health including several pathophysiological events, such as oxidative stress, DNA damage, inflammation, cellular senescence, dysregulated repair, and periodontal diseases.


Author(s):  
Skylar Y Cooper ◽  
Austin T Akers ◽  
Brandon J Henderson

Abstract Introduction Although the use of combustible cigarettes has decreased in many urban regions of America, the use of electronic nicotine delivery systems (ENDS) has dramatically increased. ENDS, or electronic cigarettes (e-cigarettes), differ from combustible cigarettes given that there are no restrictions on flavorant additives in e-liquids. With 95% of ENDS users vaping flavored e-liquids, it is critical to understand how flavors alter vaping-related behaviors. We have previously shown that menthol and green apple flavors enhance nicotine reward-related behavior in a mouse model and in the present study have investigated how menthol and green apple flavors alter e-Vape self-administration behavior in male mice. Methods Adult C57/BL6J male mice were used in vapor-inhalation self-administration assays. Mice were assigned vaping e-liquids (6 mg/mL nicotine with or without menthol or green apple flavor) to escalate on a fixed-ratio 1 (FR1) schedule in daily 3-hour sessions to examine initiation-related behaviors. Following escalation, mice were transitioned to a FR3 and progressive ratio schedules in 3-hour sessions to examine reinforcement-related behaviors. Results Here we observed that male mice exhibited increased rates of self-administration escalation on a FR1 schedule when assigned to flavored e-liquids. Upon transition to FR3, mice continued to exhibit enhanced levels of reinforcement with flavored e-liquids. We also observed that mice self-administer zero-nicotine green apple flavored e-liquids. Conclusions These data provide additional evidence that ENDS flavors enhance vaping-related initiation and reinforcement-related behavior and promote the need to continue investigating the role ENDS flavors play in vaping-related behaviors. Implications There has been much discussion recently regarding the impact of flavors on vaping-related behavior. Our study here shows that flavors significantly enhance the acquisition and reinforcement of vaping-related behavior. This suggests that flavors in electronic nicotine delivery systems significantly increase the risk of addiction-related behaviors among users of vaping products.


Author(s):  
Emina Mehanović ◽  
Federica Vigna-Taglianti ◽  
Fabrizio Faggiano ◽  
Maria Rosaria Galanti ◽  
Barbara Zunino ◽  
...  

Abstract Purpose Adolescents’ perceptions of parental norms may influence their substance use. The relationship between parental norms toward cigarette and alcohol use, and the use of illicit substances among their adolescent children is not sufficiently investigated. The purpose of this study was to analyze this relationship, including gender differences, using longitudinal data from a large population-based study. Methods The present study analyzed longitudinal data from 3171 12- to 14-year-old students in 7 European countries allocated to the control arm of the European Drug Addiction Prevention trial. The impact of parental permissiveness toward cigarettes and alcohol use reported by the students at baseline on illicit drug use at 6-month follow-up was analyzed through multilevel logistic regression models, stratified by gender. Whether adolescents’ own use of cigarette and alcohol mediated the association between parental norms and illicit drug use was tested through mediation models. Results Parental permissive norms toward cigarette smoking and alcohol use at baseline predicted adolescents’ illicit drug use at follow-up. The association was stronger among boys than among girls and was mediated by adolescents’ own cigarette and alcohol use. Conclusion Perceived parental permissiveness toward the use of legal drugs predicted adolescents’ use of illicit drugs, especially among boys. Parents should be made aware of the importance of norm setting, and supported in conveying clear messages of disapproval of all substances.


PLoS ONE ◽  
2017 ◽  
Vol 12 (3) ◽  
pp. e0170702 ◽  
Author(s):  
John W. Ayers ◽  
Eric C. Leas ◽  
Jon-Patrick Allem ◽  
Adrian Benton ◽  
Mark Dredze ◽  
...  

2015 ◽  
Vol 8 (8) ◽  
pp. 74 ◽  
Author(s):  
Maryam Kardan-Souraki ◽  
Zeinab Hamzehgardeshi ◽  
Ismail Asadpour ◽  
Reza Ali Mohammadpour ◽  
Soghra Khani

<p><strong>BACKGROUND:</strong> Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage.</p><p><strong>SEARCH METHODS:</strong> In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, <a href="http://www.cochranelibrary.com/">Cochrane Library</a>, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study.</p><p><strong>MAIN RESULTS:</strong> 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy.</p><p><strong>AUTHORS’ CONCLUSIONS:</strong> Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.</p>


2019 ◽  
Author(s):  
Belinda Borrelli ◽  
Michelle Henshaw ◽  
Romano Endrighi ◽  
William G Adams ◽  
Timothy Heeren ◽  
...  

BACKGROUND Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children. OBJECTIVE This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes. METHODS Parents with a child aged &lt;7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed–effects models. RESULTS A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child’s teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children’s teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; <italic>P</italic>=.45) and self–efficacy (F1,53=0.24; <italic>P</italic>=.63) to engage in oral health behaviors, favoring OHT (<italic>d</italic>=0.28 and <italic>d</italic>=0.16 for motivation and self–efficacy, respectively). CONCLUSIONS The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.


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