Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome

Philip Morris Products S.A.179 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

179

Conditions

Periodontal Diseases Chronic Periodontitis Periodontal Pocket

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (26)

Mase Dental Clinic

Futtsu, Chiba, Japan

Tsudanuma Olive Dental Clinic

Narashino, Chiba, Japan

Matsunobu Dental Office

Miyako, Fukuoka, Japan

Taniguchi Dental Clinic

Sapporo, Hokkaido, Japan

Takano Dental Clinic

Chikusei, Ibaraki, Japan

Tsukuba Healthcare Dental Clinic

Tsukuba, Ibaraki, Japan

AOI Universal Hospital

Kawasaki, Kanagawa, Japan

Yoshinaga Dental Office

Uki, Kumamoto, Japan

Yoshino Dental Clinic

Kawaguchi, Saitama, Japan

Saida Dental Clinic

Tokorozawa, Saitama, Japan

...and 16 more locations

Outcomes

Primary Outcomes

Periodontal Pocket Depth (PD) Change From Baseline at 6 Months

Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.

Time frame: At 6 months

Secondary Outcomes

Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)

Time frame: At 3 months

Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)

Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.

Time frame: At 3 months and 6 months

Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics