Sebastiano Antonio Pacino’s research while affiliated with University of Catania and other places

Background Although the detrimental effects of conventional combustible cigarettes on oral health and dental esthetics are well known, there is limited information about the long-term impact of combustion-free nicotine alternatives (C-F NA) such as e-cigarettes or heated tobacco products. Objective This multicenter, prospective, 3-parallel-arm randomized controlled trial will investigate whether switching from combustible cigarettes to C-F NA will lead to measurable improvements in oral health parameters and dental esthetics over 18 months in adult smokers with limited gum disease. Methods Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (control group; arm A) or C-F NA use (intervention group; arm B). The study will also include a reference group of never smokers (reference group; arm C). The primary end point is the change in the Modified Gingival Index (MGI) score from baseline between the control arm (arm A) and the intervention arm (arm B) at the 18-month follow-up. In addition, the study will analyze the within- and between-group (arms A, B, and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stain scores, and oral health–related quality of life questionnaires measured at each study time point. All participants will attend a total of 7 clinic visits: screening, enrollment, and randomization (visit 0); baseline visit—day 14 (visit 1); day 90 (visit 2); day 180 (visit 3); day 360 (visit 4); and day 540 (visit 5). This multicenter study will be conducted in 4 dental clinics in 4 countries. The statistical analysis will involve descriptive statistics for continuous and categorical data. Primary end points will undergo tests for normality and, based on distribution, either a 2-sided t test or Mann-Whitney U test. Linear mixed model with random factors center and study arms by center will also be applied. Secondary end points, including MGI assessment and quality of life, will be subjected to similar tests and comparisons. Only if one value of the parameter MGI is missing after day 1, the last available observation will be carried forward. The analysis will be performed on the substituted data. Secondary parameters will not have missing value replacement. Results Participant recruitment began in October 2021, and enrollment was completed in June 2023. Results will be reported in 2025. Conclusions This will be the first study to provide key insights into oral health benefits or risks associated with using C-F NA in smokers who are seeking alternatives to cigarette smoking. Trial Registration ClinicalTrials.gov NCT04649645; https://clinicaltrials.gov/ct2/show/NCT04649645 International Registered Report Identifier (IRRID) DERR1-10.2196/53222

Objectives Abstaining from tobacco smoking may not only improve general health, but also reduce teeth staining and restore teeth whiteness. Compared with conventional cigarettes, E-cigarettes (ECs) and heated tobacco products (HTPs) may offer substantial reduction in exposure to pigmented tar-like compounds of cigarette smoke. It is possible that improvements in dental color indices may be observed in those who have stopped smoking combustible cigarettes by switching to tar-free nicotine delivery products. Methods This cross-sectional study evaluated and compared dental color parameters by digital spectrophotometry among five different groups: individuals who currently smoke ; individuals who used to smoke but have quit ; individuals who have never smoked ; exclusive users of electronic cigarettes (former smokers) ; and exclusive users of heated tobacco products (former smokers) . Results Dental whiteness in current cigarette smokers was notably worse compared with never and former smokers, (13.38 Whiteness Index for Dentistry (WID) units vs. 19.96 and 16.79 WID units). Remarkably high WID values (i.e., whiter teeth) were also observed in ECs (16.72 WID units) and HTPs users (17.82 WID units). Compared to current smokers, difference in dental whiteness for ECs and HTPs users was visually noticeable (ΔWID difference being on average > 2.90 units). The colour differences measured as delta E*(ΔE*) were all visually detectable except for the comparison between ex-smokers and ECs users for which no perceptible color difference was observed (0.415). Conclusion Exclusive use of ECs and HTPs is associated with better dental color measurements than current smoking, suggesting that tar-free nicotine delivery technologies are unlikely to have negative effects on dental appearance. Clinical significance Use of alternative nicotine delivery systems may be associated with cosmetic benefits with important implications for those smokers perceiving dental aesthetics as a significant problem. For these an oral-based narrative may be a much more significant reason to refrain from smoking than the fear of developing smoking-related diseases in future.

UNSTRUCTURED Introduction: Although the detrimental effects of conventional combustible cigarettes (CC) on oral health and dental aesthetics are well-known, there is limited information about the long-term impact of combustion-free nicotine alternatives (C-F NA) like electronic cigarettes or heated tobacco products. Objective: This multi-center, prospective, randomized, controlled, three parallel-arms trial will investigate whether switching from CC to C-F NA will lead to measurable improvements in oral health parameters and dental aesthetics over a period of 18 months in adult smokers with limited gum disease. Methods and Analysis: Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (Control Group; Arm A) or C-F NA use (Intervention Group; Arm B). The study will also include a reference group of never-smokers (Reference Group; Arm C). The primary endpoint is the change in Modified Gingival Index (MGI) score from baseline between control arm (Arm A) and intervention arm (Arm B) at the 18-month follow-up. Additionally, the study will analyze the within- and between-group (Arm A, B and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stains scores, and oral health-related quality of life questionnaires measured at each study time point. This multicenter study will be conducted in four dental clinics in four countries. Subject recruitment has started in October 2021 and enrolment is expected to be completed by August 2023. Results will be reported in 2025. This will be the first study providing key insights into oral health benefits or risks associated with using C-F NA in smokers who are seeking alternatives to cigarette smoking.

Abstract Background The effects of smoking on the accumulation of dental plaque have not been studied in depth. We compared dental plaque quantitation obtained with a novel light induced fluorescence technology among current, former, and never smokers and verified measurements’ repeatability. Methods Dental plaque quantitation was objectively assessed by quantitative light induced fluorescence (QLF) technology on three separate study visits in current, former, and never smokers: baseline (day 0), day 7, day 30. Increase in the fluorescence intensity of at least 30% (ΔR30) and 120% (ΔR120) together with the simple oral hygiene (SOH) scoring were considered for analysis. Results The QLF parameters were highly repeatable in each study group (p

Cigarette smoking contributes to poor oral health and dental discoloration. Therefore, stopping smoking may translate into measurable amelioration of dental shade indices. We compared dental shade parameters by digital spectrophotometry among current, former, and never smokers and verified their repeatability at 7 and 30 days. Dental shade parameters (CIE L*a*b* and corresponding whiteness index for dentistry-WID) were measured in current, former, and never smokers with a digital spectrophotometer (Vita Easyshade V) on three separate study visits: at baseline (day 0), at day 7, and day 30. Dental shade parameters were analyzed in 18 current, 18 former, and 20 never smokers. The repeatability of shade parameters was consistent in current, former, and never smokers. L*, a*, b*, and WID show significant short and long-term repeatability ( p < 0.0001, by regression analyses). The mean (± SD) WID score of 13.42 (± 4.9) in current smokers was significantly lower compared to the WID score of 20.38 (± 5.3) in never smokers ( p = 0.001). No significant differences were observed between current and former smokers and between former smokers and former smokers. Dental shade measurements by digital spectrophotometry were highly reproducible and showed that teeth whiteness of current smokers is substantially inferior compared to never smokers. Objective discrimination of dental shade can be a valuable regulatory science endpoint for investigating oral hygiene and dental aesthetics of consumer care products, smoking cessation medications, and tar-free tobacco products (e-cigarettes, heated tobacco products, oral nicotine products) for cigarette substitution. Clinical trial registration: the study was not registered in ClinicalTrials.gov considering that it is a pilot study, parts of a larger project with ID: NCT04649645

Although 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.