| Primary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis. | Posted | | Mean | 95% Confidence Interval | millimeters | | At 6 months | | | | ID | Title | Description |
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| OG000 | IQOS | IQOS Product Use Category | | OG001 | Cigarette | Cigarette Product Use Category | | OG002 | Dual User | Dual User Product Use Category |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.046(-1.194 to -0.898)
- OG001-1.114(-1.258 to -0.970)
- OG002-1.177(-1.399 to -0.956)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Month 6: Difference between Cigarette and IQOS | Mixed Models Analysis | | 0.297 | | LS Mean Difference | 0.068 | | | 2-Sided | 95 | -0.060 | 0.196 | | | | | Other | | | | Month 6: Difference between Cigarette and Dual Use |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | millimeters | | At 3 months | | | | ID | Title | Description |
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| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). The "Other" reporting group, which included one subject, was not included in this analysis. | Posted | | Mean | 95% Confidence Interval | millimeters | | At 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Least Squares Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | millimeters | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Number | | Number of sites | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | Gingival Index (GI) | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | MMI | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 |
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| Secondary | Presence of Plaque on Tooth Surfaces in Full Mouth | Plaque will be measured using the plaque control record (PCR) percentage. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | Plaque Control Record % | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
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| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | Other Product Use Category - As Exposed Set |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Mean | 95% Confidence Interval | BOP % | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
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| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other |
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| Secondary | 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). | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Geometric Mean | 95% Confidence Interval | mg/g creat | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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). | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Geometric Mean | 95% Confidence Interval | pg/mg creat | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other |
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| Secondary | 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). | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment. Subjects were analyzed based on their actual self-reported product use. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements). | Posted | | Geometric Mean | 95% Confidence Interval | ng/mg creat | | From baseline to 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | |
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| Secondary | 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. | The analysis population consisted of all randomized subjects with at least one product use experience and at least one valid non-safety assessment analyzed by actual product use. Results were reported only for subjects with exposure to a specific tobacco or nicotine-containing product. | Posted | | Mean | 95% Confidence Interval | number of product units consumed | | From baseline to 6 months | | | | ID | Title | Description |
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| OG000 | IQOS | IQOS Product Use Category - As Exposed Set | | OG001 | Cigarette | Cigarette Product Use Category - As Exposed Set | | OG002 | Dual User | Dual User Product Use Category - As Exposed Set | | OG003 | Other | Other Product Use Category - As Exposed Set |
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