Changes in oral health and dental aesthetic in smokers switching to combustion-free nicotine alternatives: protocol for a multi-center prospective, randomized, controlled trial (Preprint)

Abstract

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.