ACTRN12619000882123尚未招募1 期
A phase 2a randomised controlled trial investigating the effect of CBD (cannabidiol) toothpaste and mouthwash on gingivitis versus placebo in healthy volunteers
Cannvalate (Australia)0 个研究点目标入组 40 人开始时间: 2019年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 30 Years（—）
- 性别
- All
入选标准
- •Aged between 18 and 30 years (inclusively)
- •Have current score of less than 1 on the gum bleeding index (GBI) at clinical evaluation (V0) and a score of more than 1 at randomization (V1) visit.
- •No history of gum disease
- •No known allergic reaction to cannabis products with previous use
- •Ability to speak and read English
- •Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
- •Not currently pregnant or lactating
- •Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
- •Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
- •Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- •Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
- •in good general health, without orthodontic appliances
- •a minimum of 16 natural teeth with facial and lingual scorable surfaces for consideration. Teeth with scorable surfaces exclude third molars, teeth (or implants) with crowns or bridge and teeth with large restorations covering >50% of the tooth
排除标准
- •Subjects presenting with any of the following will not be included in the trial:
- •Aged under 18 years or over 30 years.
- •A score greater than 0” on the GBI at V0 (inclusion evaluation)
- •Current gum disease
- •Previous gum disease
- •Inability to speak or read English
- •History of drug or substance abuse or current illicit drug abuse
- •History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
- •Currently pregnant or breastfeeding
- •Currently taking medications
- •Have no previous experience with cannabinoids or currently taking cannabinoids
- •Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit
- •Current smoker
研究者
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