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

Not Applicable

Completed

Conditions: Periodontal Diseases
Chronic Periodontitis
Smoking, Cigarette
Gingival Diseases
Tooth Mobility
Periodontal Pocket

Interventions: Other: Cigarette
Other: IQOS

Registration Number: NCT03364751

Lead Sponsor: Philip Morris Products S.A.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 179

Inclusion Criteria

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

Main

Exclusion Criteria

Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).
Patient received root planing therapy within the 6 months prior to Visit 1.
Patient received surgical periodontal therapy within 3 years prior to Visit
Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.
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).
Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cigarette arm	Cigarette	\~86 patients, continuing cigarette smoking.
IQOS arm	IQOS	\~86 patients, switching from cigarette smoking to IQOS use.

Primary Outcome Measures

Name	Time	Method
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months	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

Name	Time	Method
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)	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.
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)	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.
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics	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.
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics	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.
Full-mouth Periodontal PD Change Over Time.	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.
Full-mouth Clinical Attachment Level (CAL) Over Time.	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.
Peridontal PD Reduction.	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.
Clinical Attachment Level Improvement	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.
Number of Periodontally Diseased Sites.	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.
Gingival Inflammation	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.
Tooth Mobility	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.
Presence of Plaque on Tooth Surfaces in Full Mouth	From baseline to 3 months and 6 months	Plaque will be measured using the plaque control record (PCR) percentage.
Inflammatory Status in Periodontal Pockets	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.
Concentrations of Urinary Nicotine Equivalents (NEQ)	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).
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)	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).
Concentrations of 2-cyanoethylmercapturic Acid (CEMA)	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).
Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.	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.

Trial Locations

Locations (26): Yano Dental Clinic
🇯🇵
Chōfu, Tokyo, Japan
Sakai Dental Clinic
🇯🇵
Bunkyō, Tokyo, Japan
Nikaido Dental Clinic
🇯🇵
Chūō, Tokyo, Japan
Mune Dental Clinic
🇯🇵
Setagaya, Tokyo, Japan
Kikuchi Dental Clinic
🇯🇵
Shinjuku, Tokyo, Japan
Saida Dental Clinic
🇯🇵
Tokorozawa, Saitama, Japan
Yasumasu Dental Office
🇯🇵
Fukuoka, Japan
Yamashita Dental Office
🇯🇵
Fukuoka, Japan
Miyata Dental Clinic
🇯🇵
Toshima, Tokyo, Japan
Kato Dental Clinic
🇯🇵
Himi, Toyama, Japan
Kimura Dental Clinic
🇯🇵
Fukuoka, Japan
Higashi Dental Office
🇯🇵
Kumamoto, Japan
Yoshida Shigeru Dental Office
🇯🇵
Fukuoka, Japan
Tsukiyama Dental Clinic
🇯🇵
Fukuoka, Japan
Yamashita Dental Clinic
🇯🇵
Kagoshima, Japan
Heart Dental Clinic
🇯🇵
Kagoshima, Japan
Yoshinaga Dental Office
🇯🇵
Uki, Kumamoto, Japan
Tsudanuma Olive Dental Clinic
🇯🇵
Narashino, Chiba, Japan
Tsukuba Healthcare Dental Clinic
🇯🇵
Tsukuba, Ibaraki, Japan
Mase Dental Clinic
🇯🇵
Futtsu, Chiba, Japan
Matsunobu Dental Office
🇯🇵
Miyako, Fukuoka, Japan
Taniguchi Dental Clinic
🇯🇵
Sapporo, Hokkaido, Japan
Takano Dental Clinic
🇯🇵
Chikusei, Ibaraki, Japan
Yoshino Dental Clinic
🇯🇵
Kawaguchi, Saitama, Japan
AOI Universal Hospital
🇯🇵
Kawasaki, Kanagawa, Japan
Kudan Dental Clinic
🇯🇵
Chiyoda, Tokyo, Japan