Liu Jianmin, Edmiston Jeffery S, Wang Jingzhu, Milleman Kimberly R, Milleman Jeffery L, Yoder Abigale L, Gogova Maria, Sarkar Mohamadi A
Oral Health Prev Dent. 2025 Mar 25;23:189-201. doi: 10.3290/j.ohpd.c_1925.
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).
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.
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.
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.
尼古丁袋作为一种新兴的口腔烟草产品，其对口腔健康的影响尚未得到充分研究。我们评估了成年吸烟者（AS）从香烟改用on!®尼古丁袋（测试产品，TPs）相对于继续吸烟（CS）者对口腔健康指标的影响。
在这项随机、开放标签、平行组研究中，参与者被随机分配自由使用2毫克、4毫克或8毫克尼古丁TPs或继续吸烟（CS），为期24周。在基线以及第12周和第24周评估口腔健康指标，例如改良牙龈指数（MGI）、牙龈出血指数（BI）和洛贝内染色指数（LSI），并通过使用重复测量的线性混合模型分析在TPs组和CS组之间进行比较。
155名参与者被随机分组；100名（TPs组 = 48名；CS组 = 52名）完成了第12周的评估，85名（TPs组 = 40名；CS组 = 45名）完成了第24周的评估。TPs组在第12周和第24周时，尽管在基线时无意戒烟，但香烟消费量减少了90%以上。与CS组相比，以及与基线相比，TPs组在第12周（MGI降低20%；BI降低30%）和第24周（MGI降低28%；BI降低23%）时，MGI和BI有统计学显著降低（p < 0.001）。与CS组相比，TPs组的LSI也有统计学显著降低（约60%，p < 0.001）。与基线相比，CS组在第12周和第24周时LSI未观察到统计学显著变化。
本研究结果表明，在24周的使用期内，TPs对使用者的口腔健康没有负面影响。口腔健康指标的降低支持了TPs的降低危害潜力。
