Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study

Abstract

Background Smoking is a significant risk factor for periodontal disease and tooth loss, as shown in several clinical studies comparing smokers and nonsmokers. Although only a few longitudinal studies have assessed the outcome of periodontal disease after smoking cessation, they indicated that recovery after nonsurgical treatment was more successful in those who had quit smoking. As part of tobacco harm reduction strategies, substituting cigarettes with alternative, less harmful tobacco products is an approach complementary to cessation for smokers who would otherwise continue to smoke. The Tobacco Heating System (THS), developed by Philip Morris International (commercialized as IQOS), is part of the heat-not-burn product category. The IQOS device electrically heats tobacco instead of burning it, at much lower temperatures than cigarettes, thereby producing substantially lower levels of harmful and potentially harmful constituents, while providing the nicotine, taste, ritual, and a sensory experience that closely parallel those of cigarettes. Phillip Morris International has published the results from a broad clinical assessment program, which was established to scientifically substantiate the harm reduction potential of the THS among adult healthy smokers switching to the THS. The program is now progressing toward including adult smokers with smoking-related diseases. Objective The goal of this study is to demonstrate favorable changes of periodontal endpoints in response to mechanical periodontal therapy in patients with generalized chronic periodontitis who completely switched to THS use compared with continued cigarette smoking. Methods This is a randomized controlled two-arm parallel-group multicenter Japanese study conducted in patients with chronic generalized periodontitis who switch from cigarettes to THS compared with smokers continuing to smoke cigarettes for 6 months. The patients were treated with mechanical periodontal therapy as per standard of care in Japan. The primary objective of the study is to demonstrate the beneficial effect of switching to THS use compared with continued cigarette smoking on pocket depth (PD) reduction in all sites with an initial PD≥4 mm. The secondary objectives include evaluation of other periodontal parameters (eg, clinical attachment level or gingival inflammation) and overall oral health status upon switching to THS. Safety was monitored throughout the study. Results In total, 172 subjects were randomized to the cigarette (n=86) or THS (n=86) groups, and all 172 completed the study. The conduct phase of the study is completed, while data cleaning and analyses are ongoing. Conclusions This study is the first to test a heat-not-burn tobacco product in smokers with an already established disease. The results should further strengthen the evidence that switching to THS can significantly reduce the risk of smoking-related diseases if favorable changes in the evolution of chronic generalized periodontitis after mechanical therapy are found when compared with continued cigarette smoking. Trial Registration ClinicalTrials.gov NCT03364751; https://clinicaltrials.gov/ct2/show/NCT03364751 International Registered Report Identifier (IRRID) DERR1-10.2196/15350

E-cigarettes and tobacco heaters – a healthier alternative or another threat. Literature review

“…Previous studies have not shown toxicity to oral fibroblasts and keratinocytes [22], however, long-term effects need to be monitored. Beneficial changes in the course of chronic generalized inflammatory periodontitis have been observed and described in people who stopped smoking cigarettes and switched to HNB products [23].…”

Periodontal and Peri-Implant Health Status in Traditional vs. Heat-Not-Burn Tobacco and Electronic Cigarettes Smokers: A Systematic Review

“…Moreover, nicotine increases the accumulation in periodontal and peri-implant tissues of Advanced Glycation and Products (AGEs), along with their receptors (RAGEs), which have been associated with the formation of ROS (reactive oxygen species), inducing, in turn, oxidative stress and metabolic changes [ 27 , 28 ] within tissues. Currently analyzed data on MMP-8 and MMP-9, specifically activated by ROS [ 78 ], revealed significantly higher levels in CS and E-Cigs compared to NS, once more supporting the contributing role of nicotine to periodontal and peri-implant tissues destruction [ 54 , 60 , 64 ].…”

“…Tobacco heating systems instead employ a particular heating method, reaching lower temperatures (240–350 °C) compared to traditional tobacco (>600 °C) [ 26 ], thus avoiding combustion. To our knowledge, only one study, not considering self-reported periodontitis, has presented provisional results describing more favorable periodontal treatment outcomes in HNB compared to conventional tobacco smokers [ 27 ]; however, it has been reported that HNB tobacco may potentially enhance oral epithelial cell proliferation [ 28 ].…”

The product science of electrically heated tobacco products: a narrative review of the scientific literature

“…PMI have completed a randomised, controlled two-arm parallel-group multicentre Japanese study which investigated the effect of switching to a heated tobacco product on periodontal endpoints in patients with generalised chronic periodontitis (Pouly et al, 2021). A total of 172 subjects were randomised to continued conventional cigarette smoking (n=86) or switching to the heated tobacco product with all subjects completing the study.…”