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

NCT03364751 | Completed Results

• 1 other identifier: P1-OHS-01-JP
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 26

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

Conditions

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

Keywords

Oral Health; Smoking; Cigarette; Reduced risk product; Tobacco heating system; THS; Modified risk tobacco product; Clinical attachment level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)

  At 3 months

• Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)

  At 3 months and 6 months

• 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

• 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

• Full-mouth Periodontal PD Change Over Time.

  From baseline to 3 months and 6 months

Study Arms (2)

IQOS arm

ACTIVE COMPARATOR

\~86 patients, switching from cigarette smoking to IQOS use.

Other: IQOS

Cigarette arm

ACTIVE COMPARATOR

\~86 patients, continuing cigarette smoking.

Other: Cigarette

Interventions

IQOS OTHER

Patients will switch from cigarette smoking to ad libitum IQOS use.

IQOS arm

Cigarette OTHER

Patients will continue to smoke cigarettes ad libitum.

Cigarette arm

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (26)

Mase Dental Clinic

Futtsu, Chiba, 293-0001, Japan

Location

Tsudanuma Olive Dental Clinic

Narashino, Chiba, 275-0016, Japan

Location

Matsunobu Dental Office

Miyako, Fukuoka, 800-0323, Japan

Location

Taniguchi Dental Clinic

Sapporo, Hokkaido, 003-0023, Japan

Location

Takano Dental Clinic

Chikusei, Ibaraki, 308- 0031, Japan

Location

Tsukuba Healthcare Dental Clinic

Tsukuba, Ibaraki, 305-0834, Japan

Location

AOI Universal Hospital

Kawasaki, Kanagawa, 210-0822, Japan

Location

Yoshinaga Dental Office

Uki, Kumamoto, 869-0521, Japan

Location

Yoshino Dental Clinic

Kawaguchi, Saitama, 332-0016, Japan

Location

Saida Dental Clinic

Tokorozawa, Saitama, 359-1146, Japan

Location

Sakai Dental Clinic

Bunkyō, Tokyo, 113-0033, Japan

Location

Kudan Dental Clinic

Chiyoda City, Tokyo, 102-0074, Japan

Location

Yano Dental Clinic

Chōfu, Tokyo, 182-0024, Japan

Location

Nikaido Dental Clinic

Chūō, Tokyo, 103-0027, Japan

Location

Mune Dental Clinic

Setagaya City, Tokyo, 157-0072, Japan

Location

Kikuchi Dental Clinic

Shinjuku, Tokyo, 160-0023, Japan

Location

Miyata Dental Clinic

Toshima City, Tokyo, 171-0043, Japan

Location

Kato Dental Clinic

Himi, Toyama, 935-0015, Japan

Location

Kimura Dental Clinic

Fukuoka, 810-0001, Japan

Location

Yamashita Dental Office

Fukuoka, 810-0001, Japan

Location

Yasumasu Dental Office

Fukuoka, 810-0001, Japan

Location

Tsukiyama Dental Clinic

Fukuoka, 811-1302, Japan

Location

Yoshida Shigeru Dental Office

Fukuoka, 812-0011, Japan

Location

Yamashita Dental Clinic

Kagoshima, 890-0053, Japan

Location

Heart Dental Clinic

Kagoshima, 892-0844, Japan

Location

Higashi Dental Office

Kumamoto, 860-0855, Japan

Location

Related Publications (2)

• 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.

  PMID: 33459599 BACKGROUND

• 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; Zanetti, Filippo; Battey, James N. D.; de La Bourdonnaye, Guillaume; Heremans, Annie; Haziza, Christelle Journal Title: Frontiers in dental medicine Publication Date: 7/22/2022 Volume: 3 DOI: 10.3389/fdmed.2022.915079

  RESULT

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis; Periodontal Pocket; Tooth Mobility; Gingival Diseases; Cigarette Smoking; Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Christelle Haziza, Director Clinical Science & Biostatistics
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Dentist (Investigator) or Dental Hygienist performing the periodontal assessments will be blinded to the arm allocation.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 7, 2017
• Study Start: November 7, 2017
• Primary Completion: December 21, 2018
• Study Completion: June 12, 2019
• Last Updated: January 30, 2023
• Results First Posted: February 18, 2021

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (26)