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

NCT ID: NCT03364751

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2019-06-12

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.

Conditions

Periodontal Diseases; Chronic Periodontitis; Periodontal Pocket; Tooth Mobility; Gingival Diseases; Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

IQOS arm

\~86 patients, switching from cigarette smoking to IQOS use.

Group Type: ACTIVE_COMPARATOR

IQOS

Intervention Type: OTHER

Patients will switch from cigarette smoking to ad libitum IQOS use.

Cigarette arm

\~86 patients, continuing cigarette smoking.

Group Type: ACTIVE_COMPARATOR

Cigarette

Intervention Type: OTHER

Patients will continue to smoke cigarettes ad libitum.

Interventions

IQOS

Patients will switch from cigarette smoking to ad libitum IQOS use.

Intervention Type: OTHER

Cigarette

Patients will continue to smoke cigarettes ad libitum.

Intervention Type: OTHER

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products S.A.

Locations

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

Sakai Dental Clinic

Bunkyō, Tokyo, Japan

Kudan Dental Clinic

Chiyoda City, Tokyo, Japan

Yano Dental Clinic

Chōfu, Tokyo, Japan

Nikaido Dental Clinic

Chūō, Tokyo, Japan

Mune Dental Clinic

Setagaya City, Tokyo, Japan

Kikuchi Dental Clinic

Shinjuku, Tokyo, Japan

Miyata Dental Clinic

Toshima City, Tokyo, Japan

Kato Dental Clinic

Himi, Toyama, Japan

Kimura Dental Clinic

Fukuoka, , Japan

Yamashita Dental Office

Fukuoka, , Japan

Yasumasu Dental Office

Fukuoka, , Japan

Tsukiyama Dental Clinic

Fukuoka, , Japan

Yoshida Shigeru Dental Office

Fukuoka, , Japan

Yamashita Dental Clinic

Kagoshima, , Japan

Heart Dental Clinic

Kagoshima, , Japan

Higashi Dental Office

Kumamoto, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 33459599 (View on PubMed)

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

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P1-OHS-01-JP

Identifier Type: -

Identifier Source: org_study_id