Abstract
PURPOSE: The oral-health impact of nicotine pouches, an emerging category of oral tobacco products, has not been well studied. We evaluated the effects of switching from cigarettes to on!® nicotine pouches (test product, TPs) on oral-health endpoints among adult smokers (AS) relative to those who just continued smoking (CS). MATERIALS AND METHODS: In this randomised, open-label, parallel-group study, participants were randomly assigned to ad libitum use of 2, 4, or 8 mg nicotine TP or CS for 24 weeks. Oral-health endpoints, e.g., Modified Gingival Index (MGI), Gingival Bleeding Index (BI), and Lobene Stain Index (LSI)] were assessed at baseline and weeks 12 and 24, and compared between the TP and CS groups by using linear mixed model analysis for repeated measurements. RESULTS: n = 155 participants were randomised; 100 (TP = 48; CS = 52) completed week 12, and 85 (TP = 40; CS = 45) completed week 24 assessments. The TP group reduced their cigarette consumption by >90% by weeks 12 and 24 despite not intending to quit at baseline. Statistically significant reductions (p < 0.001) were observed for MGI and BI at weeks 12 (MGI = 20%; BI = 30%) and 24 (MGI = 28%; BI = 23%) in the TP group compared to the CS group, as well as compared to baseline. Statistically significant reductions (~60%, p < 0.001) were also observed for LSI in TP vs CS. No statistically significant changes were observed for LSI in the CS group at weeks 12 and 24 compared to baseline. DISCUSSION: The findings from this study suggest that TPs do not negatively impact users' oral health over 24 weeks of use. The reduction in oral health endpoints supports the harm reduction potential of TPs.