International Randomized Controlled Trial Evaluating Changes in Oral Health in Smokers After Switching to Combustion-Free Nicotine Delivery Systems: SMILE Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Modified Gingival Index (MGI)
研究概览
简要总结
Although the well-known detrimental effects of conventional cigarette smoking on oral health, there are still lack of evidences about the impact of less harmful alternatives (such as electronic cigarettes or heat not burn products), especially in young smokers with clinical absence of signs of moderate to severe periodontitis.
This study aims to investigate whether cigarette smokers who switch to combustion-free nicotine delivery systems (C-F NDS) undergo measurable improvements in oral health parameters and teeth appearance, comparing short- and long-term impact on periodontal health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers.
The investigator propose a prospective, multicenter, interventional, open label, randomized, controlled, three parallel-arms study assessing oral health parameters and teeth appearance of 18 months duration.
详细描述
SMILE is an international, open label, randomized, controlled study of 18 months duration designed to assess whether cigarette smokers switching to combustion free-nicotine delivery systems (C-F NDS) will undergo measurable improvements in oral health parameters and teeth appearance as a consequence of avoiding exposure to cigarette smoke. Five countries have so far agreed to participate: Italy, Moldova, Poland, UK and Indonesia. An amendment will be submitted to the REC once the final two countries are signed up.
A volunteer population of never-smokers and regular smokers of conventional cigarettes with a clinical absence of signs of periodontitis will be recruited. Regular cigarette smokers will be randomized 1:4 ratio either continuing to smoke commercially manufactured conventional cigarettes (Study Arm A) or switching to C-F NDS (Study Arm B). Never Smokers will be assigned to Arm C.The intended minimum number of participants by the end of the study is 460.
Before randomization, all smokers will be reminded of the risks associated with smoking and will be offered a free smoking cessation program according to standard local guidelines and depending on the local availability of antismoking services. Those who decline the invitation will be eligible for recruitment into the study.
Smokers are free to voluntarily quit smoking/C-F NDS and/or withdraw from the study at any time.
Duration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrate understanding of the study and willingness to participate in the study by providing a signed written informed consent
- •Healthy subjects, not taking regular medications for chronic medical conditions
- •Adults, age at least 18 years old.
- •Presence of at least 10 natural anterior teeth in total (cuspid to cuspid, lower and upper jaw).
- •Presence of at least 18 'scorable' teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, and third molars will not be included in the tooth count;
- •Willingness and ability to comply with the requirements of the study including installing an APP on their digital device, e.g. smart phone or tablet.
- •For Arms A and B, subject have to be:
- •Regular smokers, defined as:
- •Smoked for at least five consecutive years prior to Screening.
- •Smoked >10 and < 30 cigarettes per day (CPD).
- •with an exhaled breath carbon monoxide (CO) level ≥7 ppm at Screening.
- •willing to regularly use of any nicotine or tobacco product other than their own conventional cigarettes brand within 14 days prior to Screening.
- •willing to change to use of study products or if randomized to Arm A continuing to use their own brand of conventional cigarettes for the whole duration of the study.
- •For Arm C, subjects have to be:
- •Never-smokers, defined as:
- •never smoked or who have smoked < 100 cigarettes in their lifetime and none in the 30 days prior to screening.
- •with an exhaled breath CO level < 7 ppm at screening.
- •willing to not smoke or use any form of tobacco or nicotine-containing products for the whole duration of the study.
排除标准
- •Pregnancy.
- •Presence of extensive crown or bridge work, dental implants, and/or rampant decay (per Investigator/Examiner discretion)
- •Significant oral soft tissue pathology or any type of gingival overgrowth, other than plaque-induced gingivitis and mild periodontitis (Stage I)
- •Moderate to Severe Periodontitis (Stage II, III and IV) based on 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, which require:
- •Detectable Interdental Clinical Attachment Loss (CAL) ≥ 3 mm at ≥ 2 non-adjacent teeth.
- •Buccal or Oral CAL ≥3 mm with pocketing ≥ 5 mm detectable at ≥ 2 teeth.
- •Removable dentures or fixed and removable orthodontic appliance (except fixed lingual wires).
- •Significant history of alcoholism or drug abuse (other than tobacco/nicotine) within 24 months prior to screening, as determined by the Investigator.
- •A course of treatment with any medications or substances (other than tobacco/nicotine) which:
- •interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 3 days prior to each visit.
- •are known to have antibacterial activity (e.g. antibiotics) within 7 days prior to each visit.
研究组 & 干预措施
Standard Arm (Arm A)
Participant continues smoking their own cigarette brand.
干预措施: TOBACCO CIGARETTES (Other)
Intervention Arm (Arm B)
Participant switches to using C-F NDS.
干预措施: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS) (Other)
Control Arm (Arm C)
Participant continues to not smoking or using of any nicotine/tobacco products.
干预措施: NOT SMOKING (Other)
结局指标
主要结局
Modified Gingival Index (MGI)
时间窗: Changes in the severity of gingivitis from baseline will be assessed at 3 months, 6 months, 12 months and 18 months
Percentage (%) mean changes in MGI from baseline at different study time-points
次要结局
- Macpherson Modification of Lobene Tooth Stain Index (MLSI)(Changes in extent and severity of tooth stains from baseline will be assessed at 3 months, 6 months, 12 months and 18 months)
- Oral Health Quality of Life (OHQOL)(Changes in OHQOL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months)
- Dental Discolorations(Changes in dental discolouration from baseline will be assessed at 3 months, 6 months, 12 months and 18 months)
- Plaque Score Imaging (QLF)(Changes in dental plaque from baseline will be assessed at 3 months, 6 months, 12 months and 18 months)
- EuroQoL Visual Analog Scale (EQ VAS - QoL)(Changes in the EQ VAS - QoL score from baseline will be assessed at 3 months, 6 months, 12 months and 18 months)