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Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364751
Recruitment Status : Completed
First Posted : December 7, 2017
Results First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Conditions Periodontal Diseases
Chronic Periodontitis
Periodontal Pocket
Tooth Mobility
Gingival Diseases
Smoking, Cigarette
Interventions Other: IQOS
Other: Cigarette
Enrollment 179
Recruitment Details  
Pre-assignment Details

179 subjects were enrolled in the study. 172 subjects were randomized to the IQOS arm (n=87) or to the cigarette arm (n=85).

The analysis was performed according to subjects' exposure (Product Use Category, i.e., IQOS; Cigarette; Dual use; or Other) over the study period as detailed in the "Arm/Group" (Reporting Groups) table.

Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description

IQOS Product Use Category:

Subjects using over 30 HeatSticks, but less than 30 cigarettes monthly were classified as "IQOS" users (based on self-report).

Cigarette Product Use Category:

Monthly users of less than 30 HeatSticks, but over 30 cigarettes were classified as "Cigarette" users (based on self-report).

Dual User Product Use Category:

Users of over 30 HeatSticks and over 30 cigarettes per month were classified as "Dual User" (based on self-report).

Other Product Use Category:

All other use patterns were classified as "Other" (based on self-report).

Period Title: Overall Study
Started 70 84 17 1
Completed 69 83 17 1
Not Completed 1 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Lost to Follow-up             0             1             0             0
Arm/Group Title IQOS Cigarette Dual User Other Total
Hide Arm/Group Description IQOS Product Use Category Cigarette Product Use Category Dual User Product Use Category Other Product Use Category Total of all reporting groups
Overall Number of Baseline Participants 70 84 17 1 172
Hide Baseline Analysis Population Description
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  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants 84 participants 17 participants 1 participants 172 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 84 participants 17 participants 1 participants 172 participants
Female
13
  18.6%
17
  20.2%
3
  17.6%
0
   0.0%
33
  19.2%
Male
57
  81.4%
67
  79.8%
14
  82.4%
1
 100.0%
139
  80.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 84 participants 17 participants 1 participants 172 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
70
 100.0%
84
 100.0%
17
 100.0%
1
 100.0%
172
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 70 participants 84 participants 17 participants 1 participants 172 participants
70 84 17 1 172
Nationality  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 84 participants 17 participants 1 participants 172 participants
Japanese
70
 100.0%
84
 100.0%
17
 100.0%
1
 100.0%
172
 100.0%
Non-Japanese
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IQOS Cigarette Dual User
Hide Arm/Group Description:
IQOS Product Use Category
Cigarette Product Use Category
Dual User Product Use Category
Overall Number of Participants Analyzed 70 84 17
Mean (95% Confidence Interval)
Unit of Measure: millimeters
-1.046
(-1.194 to -0.898)
-1.114
(-1.258 to -0.970)
-1.177
(-1.399 to -0.956)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IQOS, Cigarette
Comments Month 6: Difference between Cigarette and IQOS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.068
Confidence Interval (2-Sided) 95%
-0.060 to 0.196
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cigarette, Dual User
Comments Month 6: Difference between Cigarette and Dual Use
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.064
Confidence Interval (2-Sided) 95%
-0.273 to 0.146
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IQOS Cigarette Dual User
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-0.972
(-1.120 to -0.824)
-1.016
(-1.158 to -0.873)
-1.035
(-1.257 to -0.814)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IQOS, Cigarette
Comments Month 3: Difference between Cigarette and IQOS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.502
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.043
Confidence Interval (2-Sided) 95%
-0.084 to 0.171
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cigarette, Dual User
Comments Month 3: Difference between Cigarette and Dual Use
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.851
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.020
Confidence Interval (2-Sided) 95%
-0.229 to 0.189
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IQOS Cigarette Dual User
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 83 17
Mean (95% Confidence Interval)
Unit of Measure: millimeters
Month 3: Change from Baseline Number Analyzed 70 participants 83 participants 17 participants
-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 Number Analyzed 69 participants 82 participants 17 participants
-0.903
(-1.064 to -0.743)
-0.995
(-1.150 to -0.840)
-1.100
(-1.357 to -0.843)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IQOS, Cigarette
Comments Month 3: Difference between Cigarette and IQOS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.070
Confidence Interval (2-Sided) 95%
-0.085 to 0.224
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cigarette, Dual User
Comments Month 3: Difference between Cigarette and DualUse
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.025
Confidence Interval (2-Sided) 95%
-0.229 to 0.279
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IQOS, Cigarette
Comments Month 6: Difference between Cigarette and IQOS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.092
Confidence Interval (2-Sided) 95%
-0.064 to 0.247
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cigarette, Dual User
Comments Month 6: Difference between Cigarette and Dual Use
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.105
Confidence Interval (2-Sided) 95%
-0.359 to 0.150
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category
Overall Number of Participants Analyzed 70 84 17 1
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
3.36
(3.20 to 3.52)
3.37
(3.23 to 3.51)
3.29
(3.03 to 3.54)
3.09
5.Secondary Outcome
Title Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: millimeters
Baseline Number Analyzed 70 participants 83 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
3.74
(3.48 to 3.99)
3.69
(3.46 to 3.91)
3.64
(3.24 to 4.04)
3.21
6.Secondary Outcome
Title Full-mouth Periodontal PD Change Over Time.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: millimeters
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
2.70
(2.58 to 2.82)
2.72
(2.60 to 2.84)
2.62
(2.39 to 2.84)
2.55
7.Secondary Outcome
Title Full-mouth Clinical Attachment Level (CAL) Over Time.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: millimeters
Baseline Number Analyzed 70 participants 83 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
3.10
(2.86 to 3.33)
3.09
(2.89 to 3.29)
2.97
(2.59 to 3.36)
2.70
8.Secondary Outcome
Title Peridontal PD Reduction.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: millimeters
<4mm (Baseline) Number Analyzed 70 participants 84 participants 17 participants 1 participants
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) Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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) Number Analyzed 69 participants 83 participants 17 participants 1 participants
-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) Number Analyzed 70 participants 84 participants 17 participants 1 participants
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) Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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) Number Analyzed 69 participants 83 participants 17 participants 1 participants
-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) Number Analyzed 65 participants 80 participants 17 participants 1 participants
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) Number Analyzed 65 participants 80 participants 17 participants 1 participants
-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) Number Analyzed 70 participants 79 participants 17 participants 1 participants
-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) Number Analyzed 48 participants 59 participants 14 participants 1 participants
6.0
(6.0 to 6.0)
6.0
(6.0 to 6.0)
6.0
(6.0 to 6.0)
NA [1] 
6mm-7mm (Month 3: Change from Baseline) Number Analyzed 70 participants 84 participants 17 participants 1 participants
-1.3
(-1.6 to -1.0)
-1.2
(-1.4 to -0.9)
-1.4
(-2.0 to -0.8)
NA [1] 
6mm-7mm (Month 6: Change from Baseline) Number Analyzed 47 participants 58 participants 14 participants 1 participants
-1.5
(-1.8 to -1.3)
-1.4
(-1.6 to -1.2)
-1.8
(-2.3 to -1.3)
NA [1] 
≥7mm (Baseline) Number Analyzed 32 participants 44 participants 7 participants 1 participants
7.6
(7.3 to 7.9)
7.5
(7.3 to 7.6)
8.4
(6.7 to 10.1)
NA [1] 
≥7mm (Month 3: Change from Baseline) Number Analyzed 32 participants 44 participants 7 participants 1 participants
-2.1
(-2.5 to -1.6)
-1.6
(-2.0 to -1.1)
-2.5
(-3.6 to -1.3)
NA [1] 
≥7mm (Month 6: Change from Baseline) Number Analyzed 32 participants 43 participants 7 participants 1 participants
-2.3
(-2.9 to -1.7)
-1.7
(-2.1 to -1.3)
-2.3
(-3.4 to -1.3)
NA [1] 
[1]
The sole subject in this use category did not have any sites with a PD ≥6mm.
9.Secondary Outcome
Title Clinical Attachment Level Improvement
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: millimeters
<4mm (Baseline) Number Analyzed 70 participants 83 participants 17 participants 1 participants
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) Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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) Number Analyzed 69 participants 82 participants 17 participants 1 participants
-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) Number Analyzed 70 participants 83 participants 17 participants 1 participants
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) Number Analyzed 70 participants 83 participants 17 participants 1 participants
-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) Number Analyzed 69 participants 82 participants 17 participants 1 participants
-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) Number Analyzed 65 participants 79 participants 17 participants 1 participants
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) Number Analyzed 65 participants 79 participants 17 participants 1 participants
-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) Number Analyzed 65 participants 78 participants 17 participants 1 participants
-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) Number Analyzed 48 participants 58 participants 14 participants 1 participants
6.2
(6.0 to 6.5)
6.3
(6.1 to 6.5)
6.3
(6.0 to 6.6)
NA [1] 
6mm-7mm (Month 3: Change from Baseline) Number Analyzed 48 participants 58 participants 14 participants 1 participants
-1.0
(-1.4 to -0.7)
-1.0
(-1.3 to -0.7)
-1.2
(-1.9 to -0.4)
NA [1] 
6mm-7mm (Month 6: Change from Baseline) Number Analyzed 47 participants 57 participants 14 participants 1 participants
-1.3
(-1.6 to -0.9)
-1.3
(-1.5 to -1.0)
-1.7
(-2.2 to -1.2)
NA [1] 
≥7mm (Baseline) Number Analyzed 32 participants 43 participants 7 participants 1 participants
7.5
(6.9 to 8.1)
7.9
(7.6 to 8.2)
8.8
(6.4 to 11.2)
NA [1] 
≥7mm (Month 3: Change from Baseline) Number Analyzed 32 participants 43 participants 7 participants 1 participants
-1.3
(-1.9 to -0.8)
-1.7
(-2.1 to -1.3)
-1.6
(-3.3 to 0.1)
NA [1] 
≥7mm (Month 6: Change from Baseline) Number Analyzed 32 participants 42 participants 7 participants 1 participants
-1.6
(-2.2 to -0.9)
-1.9
(-2.2 to -1.5)
-2.0
(-4.0 to 0.1)
NA [1] 
[1]
The sole subject in this use category did not have any sites with a PD ≥6mm.
10.Secondary Outcome
Title Number of Periodontally Diseased Sites.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Measure Type: Number
Unit of Measure: Number of sites
<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
11.Secondary Outcome
Title Gingival Inflammation
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: Gingival Index (GI)
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
-0.43
(-0.55 to -0.30)
-0.44
(-0.56 to -0.31)
-0.41
(-0.67 to -0.15)
0.00
12.Secondary Outcome
Title Tooth Mobility
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: MMI
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
0.18
(0.11 to 0.24)
0.19
(0.12 to 0.26)
0.23
(0.06 to 0.40)
0
Month 3 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
0.00
(-0.04 to 0.04)
-0.02
(-0.05 to 0.01)
-0.07
(-0.15 to 0.00)
0.00
13.Secondary Outcome
Title Presence of Plaque on Tooth Surfaces in Full Mouth
Hide Description Plaque will be measured using the plaque control record (PCR) percentage.
Time Frame From baseline to 3 months and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: Plaque Control Record %
Baseline Number Analyzed 69 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 69 participants 84 participants 17 participants 1 participants
-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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
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 Number Analyzed 68 participants 83 participants 17 participants 1 participants
-13.27
(-18.14 to -8.41)
-11.22
(-14.72 to -7.71)
-7.89
(-17.75 to 1.98)
-19.64
14.Secondary Outcome
Title Inflammatory Status in Periodontal Pockets
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: BOP %
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 84 participants 17 participants 1 participants
-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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
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 Number Analyzed 69 participants 83 participants 17 participants 1 participants
-14.85
(-19.16 to -10.54)
-18.71
(-22.33 to -15.10)
-11.00
(-16.83 to -5.17)
-10.71
15.Secondary Outcome
Title Concentrations of Urinary Nicotine Equivalents (NEQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/g creat
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 83 participants 17 participants 1 participants
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 Number Analyzed 68 participants 83 participants 17 participants 1 participants
6.471
(5.235 to 7.999)
6.563
(5.337 to 8.071)
5.467
(3.044 to 9.816)
5.213
16.Secondary Outcome
Title Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 83 participants 17 participants 1 participants
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 Number Analyzed 68 participants 83 participants 17 participants 1 participants
22.55
(17.28 to 29.45)
96.70
(75.97 to 123.09)
77.17
(45.80 to 130.03)
48.74
17.Secondary Outcome
Title Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mg creat
Baseline Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 70 participants 83 participants 17 participants 1 participants
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 Number Analyzed 68 participants 83 participants 17 participants 1 participants
7.56
(5.53 to 10.33)
76.65
(59.37 to 98.97)
69.02
(37.51 to 127.01)
1.97
18.Secondary Outcome
Title Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IQOS Cigarette Dual User Other
Hide Arm/Group Description:
IQOS Product Use Category - As Exposed Set
Cigarette Product Use Category - As Exposed Set
Dual User Product Use Category - As Exposed Set
Other Product Use Category - As Exposed Set
Overall Number of Participants Analyzed 70 84 17 1
Mean (95% Confidence Interval)
Unit of Measure: number of product units consumed
Cigarettes/day over the last five years (Baseline) Number Analyzed 70 participants 84 participants 17 participants 1 participants
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 Number Analyzed 21 participants 84 participants 17 participants 0 participants
0.22
(0.10 to 0.34)
17.06
(15.77 to 18.35)
8.16
(3.58 to 12.73)
IQOS Heatsticks/day Number Analyzed 70 participants 2 participants 17 participants 0 participants
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 Number Analyzed 1 participants 3 participants 2 participants 1 participants
1.67
3.72
(0.00 to 14.24)
0.01
(0.00 to 0.04)
30.00
E-cigarettes/day Number Analyzed 1 participants 0 participants 0 participants 0 participants
2.67
Nicotine Replacement Therapy/day Number Analyzed 0 participants 1 participants 0 participants 1 participants
0.81 0.50
Time Frame 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.
Adverse Event Reporting Description

The safety population comprised the 179 subjects enrolled in the study, of which 172 subjects were randomized to the IQOS or Cigarette arms.

Adverse events are reported according to subjects' product exposure over the study period (Product Use Category, i.e., IQOS use; Cigarette use; Dual use; or Other use) as detailed in the "Arm/Group" (Reporting Groups) table.

The seven subjects who were enrolled but not randomized are included in the Cigarette group for adverse event reporting.

 
Arm/Group Title IQOS Cigarette Dual Other
Hide Arm/Group Description IQOS users (safety population) Cigarette users (safety population; includes 7 subjects who were enrolled but not randomized and were considered to be in the cigarette users group) Dual users (safety population) Other users (safety population)
All-Cause Mortality
IQOS Cigarette Dual Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/91 (0.00%)      0/17 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
IQOS Cigarette Dual Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      2/91 (2.20%)      0/17 (0.00%)      0/1 (0.00%)    
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/70 (0.00%)  0 1/91 (1.10%)  1 0/17 (0.00%)  0 0/1 (0.00%)  0
Jaw cyst * 1  0/70 (0.00%)  0 1/91 (1.10%)  1 0/17 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IQOS Cigarette Dual Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/70 (35.71%)      29/91 (31.87%)      13/17 (76.47%)      1/1 (100.00%)    
Gastrointestinal disorders         
Dental caries * 1  6/70 (8.57%)  6 12/91 (13.19%)  12 3/17 (17.65%)  3 0/1 (0.00%)  0
Toothache * 1  4/70 (5.71%)  4 1/91 (1.10%)  1 0/17 (0.00%)  0 0/1 (0.00%)  0
Gingival Pain * 1  2/70 (2.86%)  2 3/91 (3.30%)  3 1/17 (5.88%)  1 0/1 (0.00%)  0
Infections and infestations         
Cellulitis * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Oral herpes * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Viral upper respiratory tract infection * 1  8/70 (11.43%)  8 5/91 (5.49%)  5 2/17 (11.76%)  2 0/1 (0.00%)  0
Gastroenteritis * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Gingivitis * 1  1/70 (1.43%)  1 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Injury, poisoning and procedural complications         
Tooth fracture * 1  2/70 (2.86%)  2 1/91 (1.10%)  1 1/17 (5.88%)  1 1/1 (100.00%)  1
Procedural Pain * 1  1/70 (1.43%)  1 4/91 (4.40%)  4 1/17 (5.88%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders         
Gout * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoarthritis * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Pain in extremity * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Oral papilloma * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Nervous system disorders         
Hyperaesthesia * 1  0/70 (0.00%)  0 2/91 (2.20%)  2 2/17 (11.76%)  2 0/1 (0.00%)  0
Product Issues         
Device breakage * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 1/17 (5.88%)  1 0/1 (0.00%)  0
Device failure * 1  1/70 (1.43%)  1 1/91 (1.10%)  1 1/17 (5.88%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/70 (0.00%)  0 0/91 (0.00%)  0 2/17 (11.76%)  2 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.

The Intellectual Property rights and research results from the present study belong to the Sponsor.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christelle Haziza, Director Clinical Science & Biostatistics
Organization: Philip Morris Products S.A.
Phone: +41 58 242 11 11
EMail: ClinicalTrials.PMI@pmi.com
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03364751    
Other Study ID Numbers: P1-OHS-01-JP
First Submitted: November 23, 2017
First Posted: December 7, 2017
Results First Submitted: November 11, 2020
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021