Status:
COMPLETED
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Periodontal Diseases
Chronic Periodontitis
Eligibility:
All Genders
30+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- Main
- Patient is aged ≥ 30 years old.
- Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years
- Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm).
- Main
Exclusion
- Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).
- Patient received root planing therapy within the 6 months prior to Visit 1.
- Patient received surgical periodontal therapy within 3 years prior to Visit
- Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.
- 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).
- Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2019
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT03364751
Start Date
November 7 2017
End Date
June 12 2019
Last Update
January 30 2023
Active Locations (26)
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1
Mase Dental Clinic
Futtsu, Chiba, Japan, 293-0001
2
Tsudanuma Olive Dental Clinic
Narashino, Chiba, Japan, 275-0016
3
Matsunobu Dental Office
Miyako, Fukuoka, Japan, 800-0323
4
Taniguchi Dental Clinic
Sapporo, Hokkaido, Japan, 003-0023