An interventional study of IQOS and Cigarette in Periodontal Diseases, Chronic Periodontitis and Periodontal Pocket, sponsored by Philip Morris Products S.A.. Completed at 26 sites in Japan. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Philip Morris Products S.A. (part of Philip Morris International) · Not applicable, Interventional, and Other
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
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.
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This study's enrollment of 179 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
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Main Inclusion Criteria:
Main Exclusion Criteria:
\~86 patients, switching from cigarette smoking to IQOS use.
Other: IQOS
\~86 patients, continuing cigarette smoking.
Other: Cigarette
Patients will switch from cigarette smoking to ad libitum IQOS use.
Patients will continue to smoke cigarettes ad libitum.
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 6 months
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 3 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: At 3 months and 6 months
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Full-mouth Periodontal PD Change Over Time.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Full-mouth Clinical Attachment Level (CAL) Over Time.
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Time frame: From baseline to 3 months and 6 months
Peridontal PD Reduction.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
Time frame: From baseline to 3 months and 6 months
Clinical Attachment Level Improvement
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
Time frame: From baseline to 3 months and 6 months
Number of Periodontally Diseased Sites.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \< 4 mm, with PD 4 mm to \< 5mm, with PD 5 mm to \< 6 mm , with PD 6 mm to \< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.
Time frame: From baseline to 3 months and 6 months
Gingival Inflammation
Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth. The gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
Time frame: From baseline to 3 months and 6 months
Tooth Mobility
Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination. Grade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction.
Time frame: From baseline to 3 months and 6 months
Presence of Plaque on Tooth Surfaces in Full Mouth
Plaque will be measured using the plaque control record (PCR) percentage.
Time frame: From baseline to 3 months and 6 months
Inflammatory Status in Periodontal Pockets
Gum inflammation was measured using percentage of teeth bleeding on probing (BOP). BOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.
Time frame: From baseline to 3 months and 6 months
Concentrations of Urinary Nicotine Equivalents (NEQ)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).
Time frame: From baseline to 3 months and 6 months
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
Time frame: From baseline to 3 months and 6 months
Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).
Time frame: From baseline to 3 months and 6 months
Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.
Time frame: From baseline to 6 months
| Milestone | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Started | 70 | 84 | 17 | 1 |
| Completed | 69 | 83 | 17 | 1 |
| Not completed | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User |
|---|---|---|---|
| Periodontal Pocket Depth (PD) Change From Baseline at 6 Months | -1.046 (-1.194 to -0.898) | -1.114 (-1.258 to -0.970) | -1.177 (-1.399 to -0.956) |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User |
|---|---|---|---|
| Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) | -0.972 (-1.120 to -0.824) | -1.016 (-1.158 to -0.873) | -1.035 (-1.257 to -0.814) |
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User |
|---|---|---|---|
| Month 3: Change from Baseline | -0.820 (-0.980 to -0.660) | -0.889 (-1.043 to -0.736) | -0.865 (-1.122 to -0.608) |
| Month 6: Change from Baseline | -0.903 (-1.064 to -0.743) | -0.995 (-1.150 to -0.840) | -1.100 (-1.357 to -0.843) |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 4.45 (4.34 to 4.56) | 4.43 (4.35 to 4.51) | 4.34 (4.25 to 4.44) | 4.07 |
| Month 3 | 3.44 (3.28 to 3.60) | 3.47 (3.34 to 3.60) | 4.34 (4.25 to 4.44) | 3.04 |
| Month 6 | 3.36 (3.20 to 3.52) | 3.37 (3.23 to 3.51) | 3.29 (3.03 to 3.54) | 3.09 |
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 4.65 (4.45 to 4.84) | 4.64 (4.45 to 4.82) | 4.60 (4.36 to 4.85) | 4.13 |
| Month 3 | 3.82 (3.57 to 4.07) | 3.79 (3.57 to 4.01) | 3.87 (3.48 to 4.26) | 3.20 |
| Month 6 | 3.74 (3.48 to 3.99) | 3.69 (3.46 to 3.91) | 3.64 (3.24 to 4.04) | 3.21 |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 3.15 (3.02 to 3.29) | 3.20 (3.09 to 3.31) | 2.99 (2.80 to 3.17) | 2.92 |
| Month 3 | 2.70 (2.59 to 2.81) | 2.78 (2.67 to 2.88) | 2.69 (2.50 to 2.88) | 2.57 |
| Month 6 | 2.70 (2.58 to 2.82) | 2.72 (2.60 to 2.84) | 2.62 (2.39 to 2.84) | 2.55 |
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 3.48 (3.26 to 3.69) | 3.52 (3.34 to 3.71) | 3.34 (3.00 to 3.69) | 2.99 |
| Month 3 | 3.10 (2.88 to 3.31) | 3.13 (2.93 to 3.32) | 3.15 (2.75 to 3.54) | 2.70 |
| Month 6 | 3.10 (2.86 to 3.33) | 3.09 (2.89 to 3.29) | 2.97 (2.59 to 3.36) | 2.70 |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| <4mm (Baseline) | 2.5 (2.5 to 2.6) | 2.6 (2.5 to 2.6) | 2.5 (2.4 to 2.6) | 2.6 |
| <4mm (Month 3: Change from Baseline) | -0.2 (-0.3 to -0.1) | -0.2 (-0.2 to -0.1) | -0.1 (-0.2 to 0.0) | -0.1 |
| <4mm (Month 6: Change from Baseline) | -0.2 (-0.3 to -0.1) | -0.2 (-0.3 to -0.2) | -0.1 (-0.3 to 0.0) | -0.1 |
| 4mm-5mm (Baseline) | 4.0 (4.0 to 4.0) | 4.0 (4.0 to 4.0) | 4.0 (4.0 to 4.0) | 4.0 |
| 4mm-5mm (Month 3: Change from Baseline) | -0.8 (-0.9 to -0.7) | -0.8 (-0.9 to -0.7) | -0.8 (-0.9 to -0.6) | -1.0 |
| 4mm-5mm (Month 6: Change from Baseline) | -0.9 (-1.0 to -0.8) | -0.9 (-1.0 to -0.8) | -0.8 (-1.1 to -0.6) | -0.9 |
| 5mm-6mm (Baseline) | 5.0 (5.0 to 5.0) | 5.0 (5.0 to 5.0) | 5.0 (5.0 to 5.0) | 5.0 |
| 5mm-6mm (Month 3: Change from Baseline) | -1.2 (-1.3 to -1.0) | -1.1 (-1.2 to -0.9) | -1.0 (-1.3 to -0.7) | -1.8 |
| 5mm-6mm (Month 6: Change from Baseline) | -1.2 (-1.4 to -1.0) | -1.2 (-1.4 to -1.1) | -1.2 (-1.6 to -0.9) | -2.0 |
| 6mm-7mm (Baseline) | 6.0 (6.0 to 6.0) | 6.0 (6.0 to 6.0) | 6.0 (6.0 to 6.0) | NA |
| 6mm-7mm (Month 3: Change from Baseline) | -1.3 (-1.6 to -1.0) | -1.2 (-1.4 to -0.9) | -1.4 (-2.0 to -0.8) | NA |
| 6mm-7mm (Month 6: Change from Baseline) | -1.5 (-1.8 to -1.3) | -1.4 (-1.6 to -1.2) | -1.8 (-2.3 to -1.3) | NA |
| ≥7mm (Baseline) | 7.6 (7.3 to 7.9) | 7.5 (7.3 to 7.6) | 8.4 (6.7 to 10.1) | NA |
| ≥7mm (Month 3: Change from Baseline) | -2.1 (-2.5 to -1.6) | -1.6 (-2.0 to -1.1) | -2.5 (-3.6 to -1.3) | NA |
| ≥7mm (Month 6: Change from Baseline) | -2.3 (-2.9 to -1.7) | -1.7 (-2.1 to -1.3) | -2.3 (-3.4 to -1.3) | NA |
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD \< 4 mm, and with initial PD of 4 mm to \<5 mm, 5 mm to \< 6 mm, 6 mm to \< 7 mm and ≥ 7 mm.
| millimeters | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| <4mm (Baseline) | 3.0 (2.8 to 3.1) | 3.0 (2.8 to 3.1) | 2.9 (2.6 to 3.3) | 2.6 |
| <4mm (Month 3: Change from Baseline) | -0.2 (-0.3 to -0.1) | -0.2 (-0.2 to -0.1) | 0.0 (-0.2 to 0.1) | -0.1 |
| <4mm (Month 6: Change from Baseline) | -0.2 (-0.3 to 0.0) | -0.2 (-0.3 to -0.1) | -0.2 (-0.4 to 0.0) | -0.1 |
| 4mm-5mm (Baseline) | 4.2 (4.1 to 4.4) | 4.2 (4.1 to 4.4) | 4.3 (4.1 to 4.6) | 4.1 |
| 4mm-5mm (Month 3: Change from Baseline) | -0.7 (-0.8 to -0.6) | -0.7 (-0.8 to -0.6) | -0.6 (-0.8 to -0.4) | -0.9 |
| 4mm-5mm (Month 6: Change from Baseline) | -0.8 (-0.9 to -0.6) | -0.8 (-0.9 to -0.7) | -0.8 (-1.0 to -0.5) | -0.9 |
| 5mm-6mm (Baseline) | 5.2 (5.0 to 5.3) | 5.2 (5.0 to 5.3) | 5.2 (5.1 to 5.4) | 5.0 |
| 5mm-6mm (Month 3: Change from Baseline) | -0.9 (-1.1 to -0.8) | -1.0 (-1.1 to -0.8) | -0.8 (-1.1 to -0.4) | -1.2 |
| 5mm-6mm (Month 6: Change from Baseline) | -1.0 (-1.2 to -0.8) | -1.1 (-1.3 to -0.9) | -1.2 (-1.6 to -0.7) | -1.8 |
| 6mm-7mm (Baseline) | 6.2 (6.0 to 6.5) | 6.3 (6.1 to 6.5) | 6.3 (6.0 to 6.6) | NA |
| 6mm-7mm (Month 3: Change from Baseline) | -1.0 (-1.4 to -0.7) | -1.0 (-1.3 to -0.7) | -1.2 (-1.9 to -0.4) | NA |
| 6mm-7mm (Month 6: Change from Baseline) | -1.3 (-1.6 to -0.9) | -1.3 (-1.5 to -1.0) | -1.7 (-2.2 to -1.2) | NA |
| ≥7mm (Baseline) | 7.5 (6.9 to 8.1) | 7.9 (7.6 to 8.2) | 8.8 (6.4 to 11.2) | NA |
| ≥7mm (Month 3: Change from Baseline) | -1.3 (-1.9 to -0.8) | -1.7 (-2.1 to -1.3) | -1.6 (-3.3 to 0.1) | NA |
| ≥7mm (Month 6: Change from Baseline) | -1.6 (-2.2 to -0.9) | -1.9 (-2.2 to -1.5) | -2.0 (-4.0 to 0.1) | NA |
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) \< 4 mm, with PD 4 mm to \< 5mm, with PD 5 mm to \< 6 mm , with PD 6 mm to \< 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.
| Number of sites | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| <4mm: Baseline | 7688 | 9194 | 1911 | 127 |
| <4mm: Month 3 | 9332 | 11146 | 2181 | 154 |
| <4mm: Month 6 | 9241 | 11199 | 2227 | 159 |
| 4mm - 5mm: Baseline | 2067 | 2571 | 469 | 37 |
| 4mm - 5mm: Month 3 | 1037 | 1393 | 261 | 14 |
| 4mm - 5mm: Month 6 | 934 | 1241 | 259 | 8 |
| 5mm - 6mm: Baseline | 724 | 1042 | 136 | 4 |
| 5mm - 6mm: Month 3 | 366 | 483 | 102 | 0 |
| 5mm - 6mm: Month 6 | 333 | 426 | 76 | 1 |
| 6mm - 7mm: Baseline | 291 | 333 | 55 | 0 |
| 6mm - 7mm: Month 3 | 151 | 238 | 31 | 0 |
| 6mm - 7mm: Month 6 | 189 | 219 | 23 | 0 |
| ≥7mm: Baseline | 220 | 222 | 15 | 0 |
| ≥7mm: Month 3 | 124 | 113 | 10 | 0 |
| ≥7mm: Month 6 | 126 | 120 | 7 | 0 |
| Missing/Not done: Baseline | 26 | 12 | 0 | 0 |
| Missing/Not done: Month 3 | 6 | 1 | 1 | 0 |
| Missing/Not done: Month 6 | 7 | 1 | 0 | 0 |
Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth. The gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
| Gingival Index (GI) | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 1.46 (1.35 to 1.57) | 1.48 (1.40 to 1.56) | 1.46 (1.28 to 1.64) | 1.38 |
| Month 3 | 1.06 (0.93 to 1.20) | 1.08 (0.97 to 1.19) | 1.22 (1.01 to 1.44) | 0.5 |
| Month 3: Change from Baseline | -0.40 (-0.52 to -0.28) | -0.40 (-0.51 to -0.29) | -0.24 (-0.44 to -0.03) | -0.88 |
| Month 6 | 1.03 (0.90 to 1.17) | 1.04 (0.93 to 1.15) | 1.05 (0.87 to 1.23) | 1.38 |
| Month 6: Change from Baseline | -0.43 (-0.55 to -0.30) | -0.44 (-0.56 to -0.31) | -0.41 (-0.67 to -0.15) | 0.00 |
Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination. Grade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction.
| MMI | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 0.18 (0.11 to 0.24) | 0.19 (0.12 to 0.26) | 0.23 (0.06 to 0.40) | 0 |
| Month 3 | 0.17 (0.10 to 0.24) | 0.16 (0.09 to 0.22) | 0.19 (0.03 to 0.34) | 0 |
| Month 3: Change from Baseline | -0.01 (-0.03 to 0.02) | -0.03 (-0.06 to -0.01) | -0.04 (-0.12 to 0.04) | 0.00 |
| Month 6 | 0.18 (0.10 to 0.26) | 0.17 (0.09 to 0.24) | 0.16 (0.04 to 0.27) | 0 |
| Month 6: Change from Baseline | 0.00 (-0.04 to 0.04) | -0.02 (-0.05 to 0.01) | -0.07 (-0.15 to 0.00) | 0.00 |
Plaque will be measured using the plaque control record (PCR) percentage.
| Plaque Control Record % | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 62.07 (57.68 to 66.46) | 62.48 (57.92 to 67.03) | 55.81 (44.62 to 67.99) | 77.68 |
| Month 3 | 48.03 (43.08 to 52.97) | 50.14 (45.66 to 54.62) | 44.56 (34.08 to 55.04) | 60.71 |
| Month 3: Change from Baseline | -14.27 (-19.04 to -9.49) | -12.34 (-15.70 to -8.99) | -11.25 (-21.45 to -1.05) | -16.96 |
| Month 6 | 49.60 (44.24 to 54.96) | 51.55 (47.20 to 55.90) | 47.92 (37.57 to 58.28) | 58.04 |
| Month 6: Change from Baseline | -13.27 (-18.14 to -8.41) | -11.22 (-14.72 to -7.71) | -7.89 (-17.75 to 1.98) | -19.64 |
Gum inflammation was measured using percentage of teeth bleeding on probing (BOP). BOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.
| BOP % | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 41.25 (35.94 to 46.56) | 42.93 (38.33 to 47.52) | 30.80 (23.96 to 37.65) | 48.81 |
| Month 3 | 26.68 (22.30 to 31.06) | 24.21 (20.70 to 27.71) | 19.03 (15.49 to 22.56) | 53.57 |
| Month 3: Change from Baseline | -14.57 (-19.03 to -10.11) | -18.72 (-21.84 to -15.60) | -11.78 (-16.48 to -7.07) | 4.76 |
| Month 6 | 26.90 (22.70 to 31.09) | 23.80 (20.10 to 27.50) | 19.80 (13.33 to 26.28) | 38.10 |
| Month 6: Change from Baseline | -14.85 (-19.16 to -10.54) | -18.71 (-22.33 to -15.10) | -11.00 (-16.83 to -5.17) | -10.71 |
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).
| mg/g creat | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 6.777 (5.625 to 8.165) | 7.649 (6.756 to 8.661) | 6.452 (3.935 to 10.580) | 8.527 |
| Month 3 | 6.766 (5.611 to 8.158) | 6.699 (5.620 to 7.986) | 5.911 (3.820 to 9.146) | 7.681 |
| Month 6 | 6.471 (5.235 to 7.999) | 6.563 (5.337 to 8.071) | 5.467 (3.044 to 9.816) | 5.213 |
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
| pg/mg creat | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 83.30 (65.33 to 106.20) | 112.52 (92.19 to 137.35) | 93.01 (58.11 to 148.84) | 159.05 |
| Mionth 3 | 25.77 (20.03 to 33.16) | 100.67 (80.95 to 125.20) | 68.62 (39.17 to 120.23) | 124.39 |
| Month 6 | 22.55 (17.28 to 29.45) | 96.70 (75.97 to 123.09) | 77.17 (45.80 to 130.03) | 48.74 |
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).
| ng/mg creat | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Baseline | 67.29 (52.25 to 86.67) | 90.44 (74.00 to 110.54) | 92.10 (59.04 to 143.66) | 140.95 |
| Month 3 | 9.94 (7.35 to 13.43) | 80.30 (63.38 to 101.74) | 50.36 (27.16 to 93.41) | 5.19 |
| Month 6 | 7.56 (5.53 to 10.33) | 76.65 (59.37 to 98.97) | 69.02 (37.51 to 127.01) | 1.97 |
Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.
| number of product units consumed | IQOS | Cigarette | Dual User | Other |
|---|---|---|---|---|
| Cigarettes/day over the last five years (Baseline) | 18.2 (16.7 to 19.7) | 17.7 (16.6 to 18.9) | 18.1 (15.1 to 21.1) | 20.0 |
| Cigarettes/day | 0.22 (0.10 to 0.34) | 17.06 (15.77 to 18.35) | 8.16 (3.58 to 12.73) | — |
| IQOS Heatsticks/day | 16.60 (15.19 to 18.02) | 0.30 (0.00 to 3.51) | 9.06 (6.86 to 11.25) | — |
| Other Heat-Not-Burn/day | 1.67 | 3.72 (0.00 to 14.24) | 0.01 (0.00 to 0.04) | 30.00 |
| E-cigarettes/day | 2.67 | — | — | — |
| Nicotine Replacement Therapy/day | — | 0.81 | — | 0.50 |
Collected over Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 31 weeks for each subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IQOS | 0/70 (0%) | 0/70 (0%) | 25/70 (35.7%) |
| Cigarette | 0/91 (0%) | 2/91 (2.2%) | 29/91 (31.9%) |
| Dual | 0/17 (0%) | 0/17 (0%) | 13/17 (76.5%) |
| Other | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | IQOS | Cigarette | Dual | Other |
|---|---|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 0/70 | 1/91 | 0/17 | 0/1 |
| Jaw cystMusculoskeletal and connective tissue disorders | 0/70 | 1/91 | 0/17 | 0/1 |
| Event | IQOS | Cigarette | Dual | Other |
|---|---|---|---|---|
| Tooth fractureInjury, poisoning and procedural complications | 2/70 | 1/91 | 1/17 | 1/1 |
| Dental cariesGastrointestinal disorders | 6/70 | 12/91 | 3/17 | 0/1 |
| Viral upper respiratory tract infectionInfections and infestations | 8/70 | 5/91 | 2/17 | 0/1 |
| HyperaesthesiaNervous system disorders | 0/70 | 2/91 | 2/17 | 0/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/70 | 0/91 | 2/17 | 0/1 |
| CellulitisInfections and infestations | 0/70 | 0/91 | 1/17 | 0/1 |
| Oral herpesInfections and infestations | 0/70 | 0/91 | 1/17 | 0/1 |
| Procedural PainInjury, poisoning and procedural complications | 1/70 | 4/91 | 1/17 | 0/1 |
| GoutMetabolism and nutrition disorders | 0/70 | 0/91 | 1/17 | 0/1 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/70 | 0/91 | 1/17 | 0/1 |
Subjects using during the course of this study over 30 HeatSticks, but less than 30 cigarettes monthly were classified as "IQOS" users. Monthly users of less than 30 HeatSticks, but over 30 cigarettes were classified as "Cigarette" users. Users of over 30 HeatSticks and over 30 cigarettes per month were classified as "Dual User". All other use patterns were classified as "Other".
| Age, Continuous(years) | IQOS | Cigarette | Dual User | Other | Total |
|---|---|---|---|---|---|
| Mean | 48.1 (30 to 71) | 46.5 (30 to 77) | 54.4 (33 to 73) | 54.0 (54 to 54) | 48.0 (30 to 77) |
| Sex: Female, Male(Participants) | IQOS | Cigarette | Dual User | Other | Total |
|---|---|---|---|---|---|
| Female | 13 | 17 | 3 | 0 | 33 |
| Male | 57 | 67 | 14 | 1 | 139 |
| Race (NIH/OMB)(Participants) | IQOS | Cigarette | Dual User | Other | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 70 | 84 | 17 | 1 | 172 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | IQOS | Cigarette | Dual User | Other | Total |
|---|---|---|---|---|---|
| Japan | 70 | 84 | 17 | 1 | 172 |
| Nationality(Participants) | IQOS | Cigarette | Dual User | Other | Total |
|---|---|---|---|---|---|
| Japanese | 70 | 84 | 17 | 1 | 172 |
| Non-Japanese | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Dec 2018, 13 months.
Results were first posted in Feb 2021, 2 years 1 month after primary completion.
Of 331 interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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