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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 52
- 主要终点
- Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The Dentist (Investigator) or Dental Hygienist performing the periodontal assessments will be blinded to the arm allocation.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
- •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.
结局指标
主要结局
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
时间窗: 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.
次要结局
- 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)
- Full-mouth Clinical Attachment Level (CAL) Over Time.(From baseline to 3 months and 6 months)
- Peridontal PD Reduction.(From baseline to 3 months and 6 months)
- Clinical Attachment Level Improvement(From baseline to 3 months and 6 months)
- Number of Periodontally Diseased Sites.(From baseline to 3 months and 6 months)
- Gingival Inflammation(From baseline to 3 months and 6 months)
- Tooth Mobility(From baseline to 3 months and 6 months)
- Presence of Plaque on Tooth Surfaces in Full Mouth(From baseline to 3 months and 6 months)
- Inflammatory Status in Periodontal Pockets(From baseline to 3 months and 6 months)
- Concentrations of Urinary Nicotine Equivalents (NEQ)(From baseline to 3 months and 6 months)
- Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)(From baseline to 3 months and 6 months)
- Concentrations of 2-cyanoethylmercapturic Acid (CEMA)(From baseline to 3 months and 6 months)
- Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.(From baseline to 6 months)