scholarly journals 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

10.2196/15350 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e15350
Author(s):  
Sandrine Pouly ◽  
Wee Teck Ng ◽  
Muriel Benzimra ◽  
Alexandre Soulan ◽  
Nicolas Blanc ◽  
...  
Keyword(s):  
Cigarette Smoking ◽  
Periodontal Disease ◽  
Harm Reduction ◽  
Significant Risk ◽  
Product Category ◽  
Heating System ◽  
Primary Objective ◽  
Periodontal Therapy ◽  
Pocket Depth ◽  
Randomized Controlled

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

scholarly journals 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 (Preprint)

2019 ◽  
Author(s):  
Sandrine Pouly ◽  
Wee Teck Ng ◽  
Muriel Benzimra ◽  
Alexandre Soulan ◽  
Nicolas Blanc ◽  
...  
Keyword(s):  
Cigarette Smoking ◽  
Periodontal Disease ◽  
Harm Reduction ◽  
Significant Risk ◽  
Product Category ◽  
Heating System ◽  
Primary Objective ◽  
Periodontal Therapy ◽  
Pocket Depth ◽  
Randomized Controlled

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. CLINICALTRIAL ClinicalTrials.gov NCT03364751; https://clinicaltrials.gov/ct2/show/NCT03364751 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15350

scholarly journals Effect of Nonsurgical Periodontal Therapy on Crevicular Fluid and Serum Glutathione Peroxidase Levels

2012 ◽  
Vol 32 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Swati Pradeep Patel ◽  
Nishanth S. Rao ◽  
A. R. Pradeep
Keyword(s):  
Oxidative Stress ◽  
Glutathione Peroxidase ◽  
Periodontal Disease ◽  
Chronic Periodontitis ◽  
Periodontal Diseases ◽  
Periodontal Therapy ◽  
Enzyme Linked Immunosorbent Assay ◽  
Pocket Depth ◽  
Nonsurgical Periodontal Therapy ◽  
Crevicular Fluid

Background: Plasma glutathione peroxidase (eGPx) is an important selenium containing antioxidant in human defense against oxidative stress. While crevicular fluid (GCF) eGPx levels and its association with periodontal disease is well documented, there is no data on correlation of GCF and serum eGPx levels in chronic periodontitis. Hence this study was undertaken to further probe into the role of oxidative stress in periodontal diseases and effect of nonsurgical periodontal therapy (NSPT) by correlating GCF and serum levels of eGPx.Materials and methods: Thirty subjects (16-Males and 14-Females; age: 30–38 years) participated in the study. The subjects were divided, based on gingival index, probing pocket depth and clinical attachment level into: Healthy (group-1,n=10), Gingivitis (group-2,n=10) and Periodontitis (group-3,n=10). Chronic periodontitis patients after NSPT constituted group 4. GCF and serum samples collected from each subject were quantified for eGPx levels using Enzyme linked Immunosorbent Assay.Results: The mean eGPx concentrations increased from health (14.01 ng/μl and 78.26 ng/ml) to gingivitis (22.86 ng/μl and 90.44 ng/ml) and then to periodontitis (29.89 ng/μl and 103.43 ng/ml), in GCF and serum respectively. After NSPT, there was statistically significant reduction in eGPx concentration in GCF and serum (19.41 ng/μl and 85.21 ng/ml). Further, all the GCF eGPx values showed a positive correlation to that of serum eGPx level.Conclusion: Thus, increased eGPx concentration in GCF can be considered as an indicator of local increase in oxidative stress. While, increase in serum eGPx levels indicates that periodontal disease can also lead to increased oxidative stress at the systemic level.

scholarly journals Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study (Preprint)

2018 ◽  
Author(s):  
S Michael Ansari ◽  
Nicola Lama ◽  
Nicolas Blanc ◽  
Marija Bosilkovska ◽  
Andrea Donelli ◽  
...  
Keyword(s):  
Harm Reduction ◽  
Combustion Process ◽  
Heating System ◽  
Tobacco Product ◽  
Smoking History ◽  
Functional Changes ◽  
Randomized Controlled ◽  
Philip Morris ◽  
Parallel Group ◽  
Subsequent Publication

BACKGROUND Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. OBJECTIVE This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of pathomechanistic pathways (ie, inflammation, oxidative stress, lipid metabolism, respiratory function, and genotoxicity), linked to smoking-related diseases, in smokers switching from combustible cigarettes to THS 2.2. METHODS This study was a randomized, controlled, two-arm parallel group, multicenter ambulatory US study conducted in healthy adult smokers switching from combustible cigarettes to THS 2.2 compared with smokers continuing to smoke combustible cigarettes for six months. Subjects had a smoking history of at least ten years and did not intend to quit within the next six months. RESULTS Enrollment started in March 2015 and the trial was completed in September 2016. In total, 984 subjects were randomized (combustible cigarettes, n=483; THS 2.2, n=477), and 803 completed the study. The results are expected to be available in a subsequent publication in 2019. CONCLUSIONS In this paper, we describe the rationale and design for this clinical study that focused on the evaluation of THS 2.2’s potential to reduce the risk of smoking-related diseases compared with that of combustible cigarettes. This study will provide insights regarding favorable changes in biological and functional endpoints informed by effects known to be seen upon smoking cessation. CLINICALTRIAL ClinicalTrials.gov NCT02396381; http://clinicaltrials.gov/ct2/show/NCT02396381 (Archived by WebCite at http://www.webcitation.org/71PCRdagP) REGISTERED REPORT IDENTIFIER RR1-10.2196/11294

A Novel Systemic Indicator of Periodontal Tissue Damage: Ischemia Modified Albumin

2018 ◽  
Vol 21 (8) ◽  
pp. 544-549 ◽  
Author(s):  
Mahmure A. Tayman ◽  
Canan Önder ◽  
Şivge Kurgan ◽  
Muhittin A. Serdar ◽  
Meral Günhan
Keyword(s):  
Periodontal Disease ◽  
Inflammatory Diseases ◽  
Periodontal Therapy ◽  
Periodontal Pocket ◽  
Oxidative Stress Marker ◽  
Pocket Depth ◽  
Ischemia Modified Albumin ◽  
Nonsurgical Periodontal Therapy ◽  
Before And After ◽  
The Impact

Background: Ischemia-modified albumin (IMA) is a systemic indicator of inflammatory diseases and is suggested as an oxidative stress marker. Objective: To determine the IMA and high-sensitivity C-reactive protein (hsCRP) serum levels for patients with chronic periodontitis (CP) and to evaluate the impact of non-surgical periodontal therapy on serum IMA and hsCRP levels. Methods: Twenty one systemically healthy patients with CP and 15 systemically and periodontally healthy controls (C) were enrolled in the study. Periodontal pocket depth (PPD), bleeding on probing (BOP) and attachment loss (AL) were recorded at the time of diagnosis and 6 weeks after the nonsurgical periodontal therapy. Blood samples were obtained before and after treatment from all groups, and serum IMA and hsCRP levels were evaluated by ELISA method. Results: All of the clinical findings were found to be elevated in the CP group in comparison to C group (p<0.05). Levels of IMA and hsCRP were higher in the CP group (p<0.05) and decreased after non-surgical periodontal therapy (p<0.05). Positive correlations were determined between PPD, BOP and hsCRP (p<0.05) as well as between PPD, AL, BOP and IMA levels (p<0.01) before treatment. A significant positive correlation was also observed between hsCRP and IMA (p<0.01) before and after treatment. Conclusion: IMA is a marker indicating systemic inflammation during periodontal disease, and is significantly reduced as a result of non-surgical periodontal therapy. Therefore, IMA might be suggested as a useful indicator of periodontal disease.

Tobacco Use and Its Effects on the Periodontium and Periodontal Therapy

2008 ◽  
Vol 9 (7) ◽  
pp. 97-107 ◽  
Author(s):  
Vandana K. Laxman ◽  
Sridhar Annaji
Keyword(s):  
Periodontal Disease ◽  
Tobacco Use ◽  
Tobacco Smoking ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Periodontal Therapy ◽  
Response To Treatment ◽  
Periodontal Health ◽  
Health Maintenance ◽  
The Relationship

Abstract Aim The purpose of this article is to present a review of the potential biological mechanisms underlying the effects of tobacco smoking on periodontal health and periodontal therapy. Background Periodontitis is the result of complex interrelationships between infectious agents and host factors. Environmental, acquired, and genetic risk factors modify the expression of disease and may, therefore, affect the onset or progression of periodontitis. Review Results The study of the relationship between periodontal disease and smoking has received increased attention during the last few years. Tobacco smoking has wide spread systemic effects, many of which may provide mechanisms for the increased susceptibility to periodontitis and the poorer response to treatment. Conclusion Tobacco smoking is a significant risk factor for periodontal disease. Clinical Significance The role smoking plays in periodontal disease should be considered by clinicians and patients during active periodontal therapy and the oral health maintenance phases of care. Citation Laxman VK, Annaji S. Tobacco Use and Its Effects on the Periodontium and Periodontal Therapy. J Contemp Dent Pract 2008 November; (9)7:097-107.

scholarly journals Clinical and microbiological effects of the initial periodontal therapy

2014 ◽  
Vol 142 (1-2) ◽  
pp. 10-16 ◽  
Author(s):  
Tanja Predin ◽  
Milanko Djuric ◽  
Jelena Mirnic ◽  
Ivana Gusic ◽  
Nadja Nikolic ◽  
...  
Keyword(s):  
Porphyromonas Gingivalis ◽  
Chronic Periodontitis ◽  
Statistical Significance ◽  
Aggregatibacter Actinomycetemcomitans ◽  
Initial Therapy ◽  
Primary Objective ◽  
Periodontal Therapy ◽  
Prevotella Intermedia ◽  
Pocket Depth ◽  
Tannerella Forsythensis

Introduction. Periodontitis is a destructive inflammatory disease of the tooth-supporting tissues, primarily caused by Gram-negative microorganisms. Thus, the primary objective of cause-related initial periodontal therapy is disruption and removal of the subgingival biofilm. Objective. The aim of this study was to evaluate the clinical and microbiological effects of the initial therapy in patients diagnosed with chronic periodontitis. Methods. Forty patients with chronic periodontitis were included in the study. As a part of the clinical assessment undertaken prior to the initial therapy, as well as one month and three months post-therapy, plaque index, gingival index, papilla bleeding index, probing pocket depth and clinical attachment level were recorded. Microbiological testing was performed prior to the initial therapy and three months after therapy. Polymerase chain reaction assays were used to determine the presence of Porphyromonas gingivalis, Tannerella forsythensis, Prevotella intermedia and Aggregatibacter actinomycetemcomitans. Results. All clinical parameters were significantly reduced after therapy. The prevalence of Aggregatibacter actinomycetemcomitans was reduced by 22.5%, which was a statistically significant decrease compared to the baseline. The prevalence of Porphyromonas gingivalis, Tannerella forsythensis and Prevotella intermedia tended to decrease after therapy; however, the difference did not reach statistical significance. Conclusion. The results of the present study demonstrated the beneficial effects of the initial periodontal therapy on both the clinical and microbiological parameters.

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