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.
