ISRCTN13243849已完成未知
Effects of two types of nicotine pouch (NP) products on oral health, specifically focusing on dental caries, soft tissues, and periodontal health in current, daily tobacco-based snus users transitioning to NPs
Swedish Match North Europe0 个研究点目标入组 45 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent for participation in the study.
- •2. Have used tobacco-based snus for =1 year, with a minimum weekly consumption of =3 cans, and =90% of the total nicotine consumption should have been tobacco-based snus
- •3. Non-smoker (have smoked =5 packages in total ever and have not smoked at all during the last year)
- •4. Healthy male or female subject aged =21 to =55 years
- •5. Normal stimulated salivary secretion rate (>0.7 ml/min)
- •6. At least 24 own teeth remaining and overall good oral health, as judged by the Investigator
- •7. Subjects of child-bearing potential must be willing to use a sufficient contraceptive method for the duration of the study. This includes mechanical barrier (e.g. a male condom or a female diaphragm), combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal anticonception associated with inhibition of ovulation (oral, injectable, implantable), intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
排除标准
- •1. History of diagnosed hypertension or any cardiovascular disease, or ongoing manifestations of hypertension or any cardiovascular disease as judged by the Investigator
- •2. Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the IP, or may either put the subject at risk because of participation in the study, influence the results, or the subject’s ability to participate in the study
- •3. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the course of the study
- •4. History of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator
- •5. Severe oral conditions such as open caries lesions, severe periodontal health, lesions in the soft tissues (apart from gingival hyperplasia related to the use of snus), or extensive prosthetic work (e.g. several implants, partial denture, dental veneers).
- •6. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator
- •7. Antibiotic use =4 weeks prior to the screening period
- •8. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 4 months of the screening visit, as judged by the Investigator
- •9. Subjects undergoing other dental treatment during the study period
- •10. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements
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