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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 : Recruiting
First Posted : December 7, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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


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 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 172 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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.



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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.

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


Contacts
Contact: Christelle Haziza, PhD 058 242 1111 Christelle.Haziza@pmi.com
Contact: Sandrine Pouly, PhD Sandrine.Pouly@pmi.com

Locations
Japan
Mase Dental Clinic Recruiting
Futtsu, Chiba, Japan, 293-0001
Contact: Shinichiro Mase    +81 439 87 8211      
Principal Investigator: Shinichiro Mase         
Tsudanuma Olive Dental Clinic Recruiting
Narashino, Chiba, Japan, 275-0016
Contact: Satoshi Ishikawa    +81-47-470-0118      
Principal Investigator: Satoshi Ishikawa         
Matsunobu Dental Office Recruiting
Miyako, Fukuoka, Japan, 800-0323
Contact: Masayasu Matsunobu    +81-930-22-1387      
Principal Investigator: Masayasu Matsunobu         
Yasumasu Dental Office Recruiting
Munakata, Fukuoka, Japan, 811-3425
Contact: Kazushi Yasumasu    +81-940-36-5775      
Principal Investigator: Kazushi Yasumasu         
Taniguchi Dental Clinic Recruiting
Sapporo, Hokkaido, Japan, 003-0023
Contact: Yoichi Taniguchi    +81-11-863-3351      
Principal Investigator: Yoichi Taniguchi         
Takano Dental Clinic Recruiting
Chikusei, Ibaraki, Japan, 308- 0031
Contact: Takuya Takano    +81- 29-625-1662      
Principal Investigator: Takuya Takano         
Tsukuba Healthcare Dental Clinic Recruiting
Tsukuba, Ibaraki, Japan, 305-0834
Contact: Otofumi Chigasaki    +81-29-860-8100      
Principal Investigator: Otofumi Chigasaki         
AOI Universal Hospital Recruiting
Kawasaki, Kanagawa, Japan, 210-0822
Contact: Satoshi Tajima    +81-44-277-5511      
Principal Investigator: Satoshi Tajima         
Yoshinaga Dental Office Recruiting
Uki, Kumamoto, Japan, 869-0521
Contact: Akihisa Ushijima    +81-964-32-5801      
Principal Investigator: Akihisa Ushijima         
Yoshino Dental Clinic Recruiting
Kawaguchi, Saitama, Japan, 332-0016
Contact: Hiroyuki Yoshino    +81-48-252-3390      
Principal Investigator: Hiroyuki Yoshino         
Saida Dental Clinic Recruiting
Tokorozawa, Saitama, Japan, 359-1146
Contact: Hiroyuki Saida    +81-42-948-3520      
Principal Investigator: Hiroyuki Saida         
Sakai Dental Clinic Recruiting
Bunkyō, Tokyo, Japan, 113-0033
Contact: Keiko Sakai    +81-3-6801-8703      
Principal Investigator: Keiko Sakai         
Kudan Dental Clinic Recruiting
Chiyoda, Tokyo, Japan, 102-0074
Contact: Tatsuro Koyanagi    +81-3-6265 -6075      
Principal Investigator: Tatsuro Koyanagi         
Yano Dental Clinic Recruiting
Chōfu, Tokyo, Japan, 182-0024
Contact: Akira Yano    +81-42-488-3351      
Principal Investigator: Akira Yano         
Nikaido Dental Clinic Recruiting
Chūō, Tokyo, Japan, 103-0027
Contact: Masahiko Nikaido    +81-3-3516-1688      
Principal Investigator: Masahiko Nikaido         
Mune Dental Clinic Recruiting
Setagaya, Tokyo, Japan, 157-0072
Contact: Munekata Sasoh    +81-3-3483-1173      
Principal Investigator: Munekata Sasoh         
Kikuchi Dental Clinic Recruiting
Shinjuku, Tokyo, Japan, 160-0023
Contact: Shigenari Kikuchi    +81-3 -5388-4071      
Principal Investigator: Shigenari Kikuchi         
Miyata Dental Clinic Recruiting
Toshima, Tokyo, Japan, 171-0043
Contact: Atsushi Miyata    +81-3-3959-0861      
Principal Investigator: Atsushi Miyata         
Kato Dental Clinic Recruiting
Himi, Toyama, Japan, 935-0015
Contact: Hazuki Kato    +81-766-74-2450      
Principal Investigator: Hazuki Kato         
Kimura Dental Clinic Recruiting
Fukuoka, Japan, 810-0001
Contact: Hidetaka Kimura    +81-92-725-1077      
Principal Investigator: Hidetaka Kimura         
Yamashita Dental Office Recruiting
Fukuoka, Japan, 810-0001
Contact: Motofumi Yamashita    +81-92-724-8155      
Principal Investigator: Motofumi Yamashita         
Tsukiyama Dental Clinic Recruiting
Fukuoka, Japan, 811-1302
Contact: Teppei Tsukiyama    +81-92-582-5454      
Principal Investigator: Teppei Tsukiyama         
Yoshida Shigeru Dental Office Recruiting
Fukuoka, Japan, 812-0011
Contact: Shigeru Yoshida    +81-92-451-2837      
Principal Investigator: Shigeru Yoshida         
Yamashita Dental Clinic Recruiting
Kagoshima, Japan, 890-0053
Contact: Daisuke Yamashita    +81-99-253-6943      
Principal Investigator: Daisuke Yamashita         
Heart Dental Clinic Recruiting
Kagoshima, Japan, 892-0844
Contact: Kota Taniguchi    +81-99-239-4618      
Principal Investigator: Kota Taniguchi         
Higashi Dental Office Recruiting
Kumamoto, Japan, 860-0855
Contact: Katsuaki Higashi    +81-96-343-3357      
Principal Investigator: Katsuaki Higashi         
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.

Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03364751     History of Changes
Other Study ID Numbers: P1-OHS-01-JP
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Gingival Diseases
Periodontal Pocket
Tooth Mobility
Mouth Diseases
Stomatognathic Diseases