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

Philip Morris

Status: Completed

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

Treatments: Other: Cigarette; Other: IQOS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364751

P1-OHS-01-JP

Details and patient eligibility

About

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

Full 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.

Enrollment: 179 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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179 participants in 2 patient groups

IQOS arm

Active Comparator group

Description:

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

Treatment:

Other: IQOS

Cigarette arm

Active Comparator group

Description:

\~86 patients, continuing cigarette smoking.

Treatment:

Other: Cigarette