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

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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 Description
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Brief Summary:

The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the 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


Condition or disease Intervention/treatment Phase
Periodontal Diseases Chronic Periodontitis Periodontal Pocket Tooth Mobility Gingival Diseases Smoking, Cigarette Other: IQOS Other: Cigarette Not Applicable

Detailed Description:
This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Masking Description: The Dentist (Investigator) or Dental Hygienist performing the periodontal assessments will be blinded to the arm allocation.
Primary Purpose: Other
Official Title: A 6-month Randomized, Controlled, Open-label, 2-arm Parallel Group, Multicenter Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Smokers With Generalized Chronic Periodontitis on the Response to Mechanical Periodontal Treatment and Oral Health Status.
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : June 12, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: IQOS arm
~86 patients, switching from cigarette smoking to IQOS use.
 Other: IQOS
Patients will switch from cigarette smoking to ad libitum IQOS use.
Active Comparator: Cigarette arm
~86 patients, continuing cigarette smoking.
 Other: Cigarette
Patients will continue to smoke cigarettes ad libitum.


Outcome Measures
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Primary Outcome Measures :
  1. Periodontal Pocket Depth (PD) Change From Baseline at 6 Months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) [ Time Frame: At 3 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.

  2. Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) [ Time Frame: At 3 months and 6 months ]
    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.

  3. Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics [ Time Frame: From baseline to 3 months and 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.

  4. Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  5. Full-mouth Periodontal PD Change Over Time. [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  6. Full-mouth Clinical Attachment Level (CAL) Over Time. [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  7. Peridontal PD Reduction. [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  8. Clinical Attachment Level Improvement [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  9. Number of Periodontally Diseased Sites. [ Time Frame: From baseline to 3 months and 6 months ]
    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.

  10. Gingival Inflammation [ Time Frame: From baseline to 3 months and 6 months ]

    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.


  11. Tooth Mobility [ Time Frame: From baseline to 3 months and 6 months ]

    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.


  12. Presence of Plaque on Tooth Surfaces in Full Mouth [ Time Frame: From baseline to 3 months and 6 months ]
    Plaque will be measured using the plaque control record (PCR) percentage.

  13. Inflammatory Status in Periodontal Pockets [ Time Frame: From baseline to 3 months and 6 months ]

    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.


  14. Concentrations of Urinary Nicotine Equivalents (NEQ) [ Time Frame: From baseline to 3 months and 6 months ]
    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).

  15. Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) [ Time Frame: From baseline to 3 months and 6 months ]
    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).

  16. Concentrations of 2-cyanoethylmercapturic Acid (CEMA) [ Time Frame: From baseline to 3 months and 6 months ]
    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).

  17. Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking. [ Time Frame: From baseline to 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Patient is aged ≥ 30 years old.
  2. Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years
  3. Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm).

Main Exclusion Criteria:

  1. Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).
  2. Patient received root planing therapy within the 6 months prior to Visit 1.
  3. Patient received surgical periodontal therapy within 3 years prior to Visit
  4. Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.
  5. Continuous systemic use of steroidal or non-steroidal anti-inflammatory drugs for more than 20 days during the past 30-day period (except for low dose aspirin, i.e., ≤300 mg).
  6. Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364751


Locations
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Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] January 9, 2019
Statistical Analysis Plan  [PDF] June 7, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03364751    
Other Study ID Numbers: P1-OHS-01-JP
First Posted: December 7, 2017    Key Record Dates
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
Oral Health
Smoking
Cigarette
Reduced risk product
 Tobacco heating system
THS
Modified risk tobacco product
Clinical attachment level
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Chronic Periodontitis
Periodontal Pocket
 Gingival Diseases
Tooth Mobility
Mouth Diseases
Stomatognathic Diseases