N/A
Completed N=172
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Periodontal diseases · Periodontitis · Periodontal Pocket · Tooth Mobility
Source: ClinicalTrials.gov NCT03364751 ↗
Enrolled (actual)
172
Serious AEs
1.1%
Results posted
Feb 2021
Primary outcomePrimary: Periodontal Pocket Depth (PD) Change From Baseline at 6 Months — -1.046; -1.114; -1.177 millimeters — p=0.297
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Periodontal Pocket Depth (PD) Change From Baseline at 6 Months |
-1.046; -1.114; -1.177 | 0.297 |
| SECONDARY Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) |
-0.972; -1.016; -1.035 | 0.502 |
| SECONDARY Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) |
-0.820; -0.889; -0.865; -0.903; -0.995; -1.100 | 0.376 |
| SECONDARY Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics |
4.45; 4.43; 4.34; 4.07; 3.44; 3.47 | — |
| SECONDARY Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics |
4.65; 4.64; 4.60; 4.13; 3.82; 3.79 | — |
| SECONDARY Full-mouth Periodontal PD Change Over Time. |
3.15; 3.20; 2.99; 2.92; 2.70; 2.78 | — |
| SECONDARY Full-mouth Clinical Attachment Level (CAL) Over Time. |
3.48; 3.52; 3.34; 2.99; 3.10; 3.13 | — |
| SECONDARY Peridontal PD Reduction. |
2.5; 2.6; 2.5; 2.6; -0.2; -0.2 | — |
| SECONDARY Clinical Attachment Level Improvement |
3.0; 3.0; 2.9; 2.6; -0.2; -0.2 | — |
| SECONDARY Number of Periodontally Diseased Sites. |
7688; 9194; 1911; 127; 9332; 11146 | — |
| SECONDARY Gingival Inflammation |
1.46; 1.48; 1.46; 1.38; 1.06; 1.08 | — |
| SECONDARY Tooth Mobility |
0.18; 0.19; 0.23; 0; 0.17; 0.16 | — |
| SECONDARY Presence of Plaque on Tooth Surfaces in Full Mouth |
62.07; 62.48; 55.81; 77.68; 48.03; 50.14 | — |
| SECONDARY Inflammatory Status in Periodontal Pockets |
41.25; 42.93; 30.80; 48.81; 26.68; 24.21 | — |
| SECONDARY Concentrations of Urinary Nicotine Equivalents (NEQ) |
6.777; 7.649; 6.452; 8.527; 6.766; 6.699 | — |
| SECONDARY Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) |
83.30; 112.52; 93.01; 159.05; 25.77; 100.67 | — |
| SECONDARY Concentrations of 2-cyanoethylmercapturic Acid (CEMA) |
67.29; 90.44; 92.10; 140.95; 9.94; 80.30 | — |
| SECONDARY Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. |
18.2; 17.7; 18.1; 20.0; 0.22; 17.06 | — |
Eligibility Criteria
Main Inclusion Criteria:
- 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 Criteria:
- 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.
Data sourced from ClinicalTrials.gov (NCT03364751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.