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

Periodontal Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364751
• Other study ID #: P1-OHS-01-JP
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: June 12, 2019

Study information

• Verified date: January 2023
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 12, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontal Pocket
• Periodontitis
• Smoking, Cigarette
• Tooth Mobility

Intervention

Other:
• IQOS
Patients will switch from cigarette smoking to ad libitum IQOS use.
• Cigarette
Patients will continue to smoke cigarettes ad libitum.

Locations

Country	Name	City	State
Japan	Sakai Dental Clinic	Bunkyo	Tokyo
Japan	Takano Dental Clinic	Chikusei	Ibaraki
Japan	Kudan Dental Clinic	Chiyoda	Tokyo
Japan	Yano Dental Clinic	Chofu	Tokyo
Japan	Nikaido Dental Clinic	Chuo	Tokyo
Japan	Kimura Dental Clinic	Fukuoka
Japan	Tsukiyama Dental Clinic	Fukuoka
Japan	Yamashita Dental Office	Fukuoka
Japan	Yasumasu Dental Office	Fukuoka
Japan	Yoshida Shigeru Dental Office	Fukuoka
Japan	Mase Dental Clinic	Futtsu	Chiba
Japan	Kato Dental Clinic	Himi	Toyama
Japan	Heart Dental Clinic	Kagoshima
Japan	Yamashita Dental Clinic	Kagoshima
Japan	Yoshino Dental Clinic	Kawaguchi	Saitama
Japan	AOI Universal Hospital	Kawasaki	Kanagawa
Japan	Higashi Dental Office	Kumamoto
Japan	Matsunobu Dental Office	Miyako	Fukuoka
Japan	Tsudanuma Olive Dental Clinic	Narashino	Chiba
Japan	Taniguchi Dental Clinic	Sapporo	Hokkaido
Japan	Mune Dental Clinic	Setagaya	Tokyo
Japan	Kikuchi Dental Clinic	Shinjuku	Tokyo
Japan	Saida Dental Clinic	Tokorozawa	Saitama
Japan	Miyata Dental Clinic	Toshima	Tokyo
Japan	Tsukuba Healthcare Dental Clinic	Tsukuba	Ibaraki
Japan	Yoshinaga Dental Office	Uki	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Effect of switching from cigarette smoking to the use of the tobacco heating system on periodontitis treatment outcome: Periodontal parameter results from a multicenter Japanese study Authors: Pouly, Sandrine; Ng, Wee Teck; Blanc, Nicolas; Hession, Paul;

Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Haziza C. Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study. JMIR Res Protoc. 2021 Jan 18;10(1):e15350. doi: 10.2196/15350. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At 6 months
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.	At 3 months
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.	At 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
Secondary	Presence of Plaque on Tooth Surfaces in Full Mouth	Plaque will be measured using the plaque control record (PCR) percentage.	From baseline to 3 months and 6 months
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.	From baseline to 3 months and 6 months
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).	From baseline to 3 months and 6 months
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).	From baseline to 3 months and 6 months
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).	From baseline to 3 months and 6 months
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.	From baseline to 6 months