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Currently submitted to: JMIR Research Protocols

Date Submitted: Jul 4, 2019
Open Peer Review Period: Jul 8, 2019 - Jul 22, 2019
(currently open for review)

Design and rationale for a randomized, controlled, multicenter study in Japan to evaluate the effect of switching to the use of the Tobacco Heating System versus continued cigarette smoking on chronic generalized periodontitis treatment outcome

  • Sandrine Pouly; 
  • Wee Teck Ng; 
  • Muriel Benzimra; 
  • Alexandre Soulan; 
  • Nicolas Blanc; 
  • Filippo Zanetti; 
  • Patrick Picavet; 
  • Gizelle Baker; 
  • Frank Lüdicke; 
  • Christelle Haziza

ABSTRACT

Background:

Smoking is known to be a significant risk factor for periodontal disease and tooth loss, as shown in several clinical studies comparing smokers and non-smokers. Only a few longitudinal studies have assessed the outcome of periodontal disease after smoking cessation, but they indicate that the recovery after non-surgical treatment is more successful in those who 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 (PMI) and commercialized as IQOS®, is part of the heat-not-burn product category. The 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 nicotine, taste, ritual, and a sensory experience that closely parallel those of cigarettes. PMI has published the results from a broad clinical assessment program, which was established to scientifically substantiate the harm reduction potential of THS in adult healthy smokers switching to THS. The program is now progressing toward diseased adult smokers.

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, 2-arm parallel group, multicenter Japanese study conducted in patients with chronic generalized periodontitis switching from cigarettes to THS compared with smokers continuing to smoke cigarettes for 6 months. 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 initial PD ≥ 4 mm. The secondary objectives include the evaluation of other periodontal parameters (e.g., 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 cigarette (n=86) or THS (n=86) groups, and 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 in which a heat-not-burn tobacco product has been tested in smokers with an already established disease. Results should further strengthen the evidence that switching to THS can significantly reduce the risk of smoking-related diseases, if demonstrated here by favorable changes in the evolution of chronic generalized periodontitis after mechanical therapy when compared with continued cigarette smoking. Clinical Trial: ClinicalTrials.gov identifiers: NCT03364751


 Citation

Please cite as:

Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Lüdicke F, Haziza C

Design and rationale for a randomized, controlled, multicenter study in Japan to evaluate the effect of switching to the use of the Tobacco Heating System versus continued cigarette smoking on chronic generalized periodontitis treatment outcome

JMIR Preprints. 04/07/2019:15350

DOI: 10.2196/preprints.15350

URL: https://preprints.jmir.org/preprint/15350


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