Clinical trial NCT03364751: Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Official title: A 6-month Randomized, Controlled, Open-label, 2-arm Parallel Group, Multicenter Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Smokers With Generalized Chronic Periodontitis on the Response to Mechanical Periodontal Treatment and Oral Health Status.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Chronic Periodontitis
Periodontal Pocket
Tooth Mobility
Gingival Diseases
Smoking, Cigarette
Keywords: Oral Health
Smoking
Cigarette
Reduced risk product
Tobacco heating system
THS
Modified risk tobacco product
Clinical attachment level
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2017-12-07
Enrollment: 179
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking.

Note: "IQOS" is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan under the brand name IQOS

Detailed description: This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 cigarettes/day vs. \> 19 cigarettes/day) and disease severity recorded at Visit 1 (\< 5 mm Pocket Depth \[PD\] vs. ≥ 5 mm PD) based on the most severely diseased tooth, in smokers with generalized chronic periodontitis who are randomized to either switch from cigarette smoking to IQOS use or continuing cigarette smoking.

Eligibility criteria: Main Inclusion Criteria:

1. Patient is aged ≥ 30 years old.
2. Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years
3. Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm).

Main Exclusion Criteria:

1. Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).
2. Patient received root planing therapy within the 6 months prior to Visit 1.
3. Patient received surgical periodontal therapy within 3 years prior to Visit
4. Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.
5. Continuous systemic use of steroidal or non-steroidal anti-inflammatory drugs for more than 20 days during the past 30-day period (except for low dose aspirin, i.e., ≤300 mg).
6. Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.

Primary outcomes:
measure: Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
timeFrame: At 6 months
Secondary outcomes:
measure: Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
timeFrame: At 3 months
measure: Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
timeFrame: At 3 months and 6 months
measure: Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
timeFrame: From baseline to 3 months and 6 months
measure: Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
timeFrame: From baseline to 3 months and 6 months
measure: Full-mouth Periodontal PD Change Over Time.
timeFrame: From baseline to 3 months and 6 months
measure: Full-mouth Clinical Attachment Level (CAL) Over Time.
timeFrame: From baseline to 3 months and 6 months
measure: Peridontal PD Reduction.
timeFrame: From baseline to 3 months and 6 months
measure: Clinical Attachment Level Improvement
timeFrame: From baseline to 3 months and 6 months
measure: Number of Periodontally Diseased Sites.
timeFrame: From baseline to 3 months and 6 months
measure: Gingival Inflammation
timeFrame: From baseline to 3 months and 6 months
measure: Tooth Mobility
timeFrame: From baseline to 3 months and 6 months
measure: Presence of Plaque on Tooth Surfaces in Full Mouth
timeFrame: From baseline to 3 months and 6 months
measure: Inflammatory Status in Periodontal Pockets
timeFrame: From baseline to 3 months and 6 months
measure: Concentrations of Urinary Nicotine Equivalents (NEQ)
timeFrame: From baseline to 3 months and 6 months
measure: Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
timeFrame: From baseline to 3 months and 6 months
measure: Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
timeFrame: From baseline to 3 months and 6 months
measure: Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Futtsu
country: Japan
facility: Mase Dental Clinic
state: Chiba
city: Narashino
country: Japan
facility: Tsudanuma Olive Dental Clinic
state: Chiba
city: Miyako
country: Japan
facility: Matsunobu Dental Office
state: Fukuoka
city: Sapporo
country: Japan
facility: Taniguchi Dental Clinic
state: Hokkaido
city: Chikusei
country: Japan
facility: Takano Dental Clinic
state: Ibaraki
city: Tsukuba
country: Japan
facility: Tsukuba Healthcare Dental Clinic
state: Ibaraki
city: Kawasaki
country: Japan
facility: AOI Universal Hospital
state: Kanagawa
city: Uki
country: Japan
facility: Yoshinaga Dental Office
state: Kumamoto
city: Kawaguchi
country: Japan
facility: Yoshino Dental Clinic
state: Saitama
city: Tokorozawa
country: Japan
facility: Saida Dental Clinic
state: Saitama
city: Bunkyō
country: Japan
facility: Sakai Dental Clinic
state: Tokyo
city: Chiyoda
country: Japan
facility: Kudan Dental Clinic
state: Tokyo
city: Chōfu
country: Japan
facility: Yano Dental Clinic
state: Tokyo
city: Chūō
country: Japan
facility: Nikaido Dental Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Mune Dental Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Kikuchi Dental Clinic
state: Tokyo
city: Toshima
country: Japan
facility: Miyata Dental Clinic
state: Tokyo
city: Himi
country: Japan
facility: Kato Dental Clinic
state: Toyama
city: Fukuoka
country: Japan
facility: Kimura Dental Clinic
city: Fukuoka
country: Japan
facility: Yamashita Dental Office
city: Fukuoka
country: Japan
facility: Yasumasu Dental Office
city: Fukuoka
country: Japan
facility: Tsukiyama Dental Clinic
city: Fukuoka
country: Japan
facility: Yoshida Shigeru Dental Office
city: Kagoshima
country: Japan
facility: Yamashita Dental Clinic
city: Kagoshima
country: Japan
facility: Heart Dental Clinic
city: Kumamoto
country: Japan
facility: Higashi Dental Office
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
References:
citation: Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Haziza C. 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. JMIR Res Protoc. 2021 Jan 18;10(1):e15350. doi: 10.2196/15350.
citation: Effect of switching from cigarette smoking to the use of the tobacco heating system on periodontitis treatment outcome: Periodontal parameter results from a multicenter Japanese study Authors: Pouly, Sandrine; Ng, Wee Teck; Blanc, Nicolas; Hession, Paul; Zanetti, Filippo; Battey, James N. D.; de La Bourdonnaye, Guillaume; Heremans, Annie; Haziza, Christelle Journal Title: Frontiers in dental medicine Publication Date: 7/22/2022 Volume: 3 DOI: 10.3389/fdmed.2022.915079