Trials / Completed
CompletedNCT03364751
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 179 (actual)
- Sponsor
- Philip Morris Products S.A. · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | IQOS | Patients will switch from cigarette smoking to ad libitum IQOS use. |
| OTHER | Cigarette | Patients will continue to smoke cigarettes ad libitum. |
Timeline
- Start date
- 2017-11-07
- Primary completion
- 2018-12-21
- Completion
- 2019-06-12
- First posted
- 2017-12-07
- Last updated
- 2023-01-30
- Results posted
- 2021-02-18
Locations
26 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03364751. Inclusion in this directory is not an endorsement.