Effect of Aerosol From THS and Cigarette Smoke on Periodontal Tissues and Its Microbiome

NCT06480877 | Completed DMC FDA Device

• 1 other identifier: 2170-29-02/1-23-2
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoke has an adverse effect on the entire body as well as on the supporting apparatus of the teeth. THS (tobacco heating system) are new products on the market in which tobacco is heated and not burned like in classic cigarettes. Cigarette smoke negatively affects the immune system and vascularization, while the microbiological diversity of the dental biofilm of smokers shows a high prevalence of periodontal pathogens. The effect of THS aerosols on periodontal tissues has not been fully investigated. The research would focus on the impact of cigarette smoking and THS on periodontal tissues and compare their effects as measured by periodontal indices and subgingival microbiome analysis. Periodontal indices will give an insight into the health condition of the periodontal tissues. The microbiological profile of the subgingival areas will serve as an indicator of the effect of cigarette smoke and aerosol emitted by THS on the specific subgingival microbiome. Changes in the composition of the oral subgingival microbiome caused by environmental factors such as smoking will be analyzed using Next generation sequencing (NGS).

Conditions

Periodontal Diseases; Dysbiosis

Keywords

Periodontitis, smoking, Electronic Cigarettes, 16 s RRNA

Outcome Measures

Primary Outcomes (1)

• Periodontal indices

  Three groups were formed (each N = 22): (I) subjects smoking classic cigarettes, (II) users of tobacco heating devices , and (III) subjects who have never smoked either classic cigarettes or used the THS system. Subjects were further classified into subgroups with periodontitis and without periodontitis. The procedure of each subject consisted of taking anamnestic data, clinical examination of the oral cavity, analysis of panoramic dental radiographs, and taking paper-point sample swabs from gingival sulci or periodontal pockets. Clinical examination included examination of all teeth except third molars. A millimeter graduated PCP-15 UNC periodontal probe (Hu-Friedy, Chicago, IL, USA) was used to record the following periodontal indices: probing depth , Full Mouth Bleeding Score , Full Mouth Plaque Score, gingival recession, tooth mobility, furcation defects, and clinical attachment level.

  1 year

Secondary Outcomes (1)

• results from 16S rRna sequencing

  1 year

Study Arms (3)

IQOS users

Inclusion criteria were good general health, absence of any lesions below at or above the level of the oral mucosa, and minimum of 20 healthy teeth. Smokers had to meet the criteria for smoking experience that was at least 3 years (classic cigarette or THS) and daily consumption which should not be less than 5 cigarettes or heat sticks per day. Selected subjects were only cigarette smokers for Group I, and the same rule of selection was applied for IQOS users as Group II.

Diagnostic Test: Taking a swab from periodontal pockets or gingival sulci

Cigarette smokers

Inclusion criteria were good general health, absence of any lesions below at or above the level of the oral mucosa, and minimum of 20 healthy teeth. Smokers had to meet the criteria for smoking experience that was at least 3 years (classic cigarette or THS) and daily consumption which should not be less than 5 cigarettes or heat sticks per day. Selected subjects were only cigarette smokers for Group I, and the same rule of selection was applied for IQOS users as Group II.

Diagnostic Test: Taking a swab from periodontal pockets or gingival sulci

Control group-non smokers

Inclusion criteria were good general health, absence of any lesions below at or above the level of the oral mucosa, and minimum of 20 healthy teeth. Smokers had to meet the criteria for smoking experience that was at least 3 years (classic cigarette or THS) and daily consumption which should not be less than 5 cigarettes or heat sticks per day. Selected subjects were only cigarette smokers for Group I, and the same rule of selection was applied for IQOS users as Group II.

Diagnostic Test: Taking a swab from periodontal pockets or gingival sulci

Interventions

Taking a swab from periodontal pockets or gingival sulci DIAGNOSTIC_TEST

Swabs for next generation sequencing were taken with paper points as described earlier.

Cigarette smokers; Control group-non smokers; IQOS users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects were 26-56 years old (median 38; interquartile range 34-54), and 42/66 (64%) were female.

You may not qualify if:

• Minors, pregnant women, subjects who use oral probiotics, subjects who have been under antibiotic therapy for the past six (6) months, subjects who use oral antiseptics based on chlorhexidine daily, subjects under immunosuppressive therapy, subjects under any medication therapy and subjects who were in previous periodontal therapy were excluded from the research.

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinical medical hospital centre Rijeka

Rijeka, 51000, Croatia

Location

Related Publications (6)

• D'Ambrosio F, Pisano M, Amato A, Iandolo A, Caggiano M, Martina S. Periodontal and Peri-Implant Health Status in Traditional vs. Heat-Not-Burn Tobacco and Electronic Cigarettes Smokers: A Systematic Review. Dent J (Basel). 2022 Jun 8;10(6):103. doi: 10.3390/dj10060103.

  PMID: 35735645 RESULT

• Bizzarro S, Loos BG, Laine ML, Crielaard W, Zaura E. Subgingival microbiome in smokers and non-smokers in periodontitis: an exploratory study using traditional targeted techniques and a next-generation sequencing. J Clin Periodontol. 2013 May;40(5):483-92. doi: 10.1111/jcpe.12087. Epub 2013 Mar 13.

  PMID: 23489056 RESULT

• Gonzalez-Garay ML. The road from next-generation sequencing to personalized medicine. Per Med. 2014;11(5):523-544. doi: 10.2217/pme.14.34.

  PMID: 26000024 RESULT

• Yoshioka T, Tabuchi T. Combustible cigarettes, heated tobacco products, combined product use, and periodontal disease: A cross-sectional JASTIS study. PLoS One. 2021 Mar 30;16(3):e0248989. doi: 10.1371/journal.pone.0248989. eCollection 2021.

  PMID: 33784312 RESULT

• Perez-Chaparro PJ, Duarte PM, Pannuti CM, Figueiredo LC, Mestnik MJ, Goncalves CP, Faveri M, Feres M. Evaluation of human and microbial DNA content in subgingival plaque samples collected by paper points or curette. J Microbiol Methods. 2015 Apr;111:19-20. doi: 10.1016/j.mimet.2015.01.023. Epub 2015 Jan 30.

  PMID: 25644890 RESULT

• Shiloah J, Patters MR, Waring MB. The prevalence of pathogenic periodontal microflora in healthy young adult smokers. J Periodontol. 2000 Apr;71(4):562-7. doi: 10.1902/jop.2000.71.4.562.

  PMID: 10807119 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Sampling was carried out by taking a paper-point sample swabs for microbiological analysis from five selected gingival sulci or periodontal pockets of five selected teeth. The teeth were isolated in a dry working field to prevent contamination of the paper points with saliva, and were additionally dried with compressed air. Supragingival biofilm was cleaned from the sampling area with sterile cotton pellet, paper point size 45 (Roeko #45 Dental Paper Point, Coltene Whaladent, USA) per tooth was inserted into the gingival sulcus or periodontal pocket for 30 seconds and placed into an empty Eppendorf tube. The tube was then stored at a temperature of -20 °C. The samples were stored until bacterial DNA isolation. Isolation of bacterial DNA was performed within 48 h of collection.

MeSH Terms

Conditions

Periodontal Diseases; Dysbiosis; Periodontitis; Smoking; Vaping

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Stjepan Spalj, PhD

  Clinical medical hospital centre Rijeka

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 28, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 1.09.2024 till 1.9.2025

Locations

CR (1)