Catania, 20 February 2024 – CoEHAR researchers have launched an unprecedented global health initiative, the SMILE Study. This is the first large prospective trial that will measure changes in oral health parameters and dental aesthetics of more than 400 smokers who transition from tobacco cigarettes to combustion-free nicotine delivery alternatives.
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Although the negative effects of cigarette smoking on oral health and teeth discoloration are well-known, there is only limited data about the impact of combustion-free nicotine alternatives like ecigs and heated tobacco products. In particular, there are no long-term studies assessing the impact on oral health and teeth appearance when substituting conventional cigarettes for these combustion-free nicotine delivery alternatives.
The study was specifically designed to address these research questions. In particular, this study tests the hypothesis that avoiding exposure to cigarette smoke toxicants may translate into measurable amelioration in gingival response, dental plaque build-up, enamel discoloration, and tooth staining in subjects with mild-moderate gingivitis by comparing subjects who smoke tobacco cigarette with those who switch to using combustion-free product or subjects who never smoked.
The study is being conducted in four dental clinics across four different countries (Italy, Poland, Moldova, and Indonesia). Subjects’ enrolment was completed in August 2023 and results will be expected to be available in 2025.
The primary objective of the study is to compare the percentage mean change in the Modified Gingival Index (MGI) score, a key indicator of gingival health, between baseline and the 18-month follow-up among the study groups. Secondary outcomes will evaluate variations in tooth stains, dental discolorations, plaque scores, and quality of life assessments related to oral health.
“The study is being conducted in many different locations worldwide, posing the challenge of finding a primary endpoint that could be measured by different operators across sites using a standardized measurement system already used in previous studies. The Modified Gingival Index (MGI) was chosen as the primary index because it is widely used, simple, non-invasive, and reproducible, enabling comparison of results across different sites and operators” – explain prof. Eugenio Pedullà, University of Catania, Co-Project leader of Smile Study.
The SMILE study is characterized by unique innovative solutions. This study introduces a novel approach to smoking cessation by offering a diverse range of popular combustion-free nicotine alternatives, allowing participants to choose based on personal preference, aiming to enhance adherence and reduce cigarette smoking. Additionally, the VERITAS study examines the impact of switching to combustion-free nicotine alternatives on oral health, including gum health, bad breath, and teeth appearance, using modern cutting-edge technologies like digital spectrophotometry and Quantitative Light-induced Fluorescence (QLF) for objective measurement. The study emphasizes the importance of personal oral hygiene and dietary patterns, ensuring consistent measurement and adherence to the research protocol.
Data from this study will provide valuable key insights into the potential benefit and/or risks associated with the regular long-term use of combustion-free nicotine alternatives. In addition, findings may have important implications for reducing smoking burden globally, especially for those smokers for which bad breath and/or poor dental aesthetic is a significant concern. For these individuals, an oral-centric narrative (such as achieving a healthier and brighter smile) may serve as a more compelling reason to quit smoking than the fear of future lung cancer or cardiopulmonary diseases.
According to prof. Riccardo Polosa, Founder of the CoEHAR: “Major health organizations in the UK support the use of electronic cigarettes, emphasizing the lack of evidence that these products cause tooth decay or gum disease. Recently, CoEHARresearchers have published that tar-free nicotine delivery devices, like electronic cigarettes or heated tobacco products, can improve the aesthetic appearance of teeth and reduce the formation of dental plaque. The SMILE study seeks to definitively clear up false claims about vaping and oral health, making a significant contribution in the fight against smoking by also actively engaging dental clinics and offices around the world”.
“Several oral health parameters measured in this study are linked to the development of periodontal diseases – concluded prof. Gianna Maria Nardi, Associate Professor Sapienza University of Rome, Department of Odontostomatological and Maxillofacial Sciences – It is noteworthy that the progression from chronic gingivitis to periodontitis raises the risk of cardiovascular disease, thereby underscoring the broader health implications of the study’s results”
“Our mission – conclude prof. Polosa – is to train the dentists of the future who will benefit of innovative tools and more effective techniques to enhance the smiles of millions of individuals”.
