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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
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE November 23, 2017
First Posted Date  ICMJE December 7, 2017
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE November 7, 2017
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
Periodontal pocket depth (PD) reduction. [ Time Frame: From baseline to 6 months ]
Mean Periodontal PD reduction 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03364751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • Periodontal pocket depth (PD) change over time. [ Time Frame: From baseline to 3 months ]
    Mean Periodontal PD change 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.
  • Clinical Attachment Level (CAL) change over time. [ Time Frame: From baseline to 3 months and 6 months ]
    Mean CAL change 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.
  • Full-mouth periodontal PD change over time. [ Time Frame: From baseline to 3 months and 6 months ]
    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.
  • Full-mouth Clinical Attachment Level (CAL) over time. [ Time Frame: From baseline to 3 months and 6 months ]
    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.
  • Peridontal PD reduction. [ Time Frame: From baseline to 3 months and 6 months ]
    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.
  • Clinical Attachment Level improvement. [ Time Frame: From baseline to 3 months and 6 months ]
    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
  • Number of periodontally diseased sites. [ Time Frame: From baseline to 3 months and 6 months ]
    Any change will be recorded in the number of diseased sites with 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.
  • 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.
  • Tooth mobility [ Time Frame: From baseline to 3 months and 6 months ]
    Tooth mobility will be measured using Miller's classification (grade 0 to grade 3).
  • 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.
  • Inflammatory status in periodontal pockets [ Time Frame: From baseline to 3 months and 6 months ]
    PD inflammation will be measured with bleeding on probing (BOP) percentage.
  • 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.
  • Total 4-[methylnitrosamino]-1-[3-pyridyl]-1- butanol (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.
  • 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.
  • 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.
  • Safety during the study [ Time Frame: For the duration of the study (6 months) ]
    To monitor safety over the duration of the study, the following parameters will be measured: Incidence of adverse events (AEs)/serious adverse events (SAEs), including AEs related to device events, and device events, including device malfunction/misuse.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
Official Title  ICMJE 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.
Brief Summary

The purpose of this study is 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

Detailed Description This is 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Periodontal Diseases
  • Chronic Periodontitis
  • Periodontal Pocket
  • Tooth Mobility
  • Gingival Diseases
  • Smoking, Cigarette
Intervention  ICMJE
  • Other: IQOS
    Patients will switch from cigarette smoking to ad libitum IQOS use.
  • Other: Cigarette
    Patients will continue to smoke cigarettes ad libitum.
Study Arms  ICMJE
  • Active Comparator: IQOS arm
    ~86 patients, switching from cigarette smoking to IQOS use.
    Intervention: Other: IQOS
  • Active Comparator: Cigarette arm
    ~86 patients, continuing cigarette smoking.
    Intervention: Other: Cigarette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2017)
172
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 12, 2019
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03364751
Other Study ID Numbers  ICMJE P1-OHS-01-JP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philip Morris Products S.A.
Study Sponsor  ICMJE Philip Morris Products S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
PRS Account Philip Morris Products S.A.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP