A Randomised, Controlled, Examiner Blind Study to Evaluate the Effect of a Sodium Bicarbonate Toothpaste on the Oral Microbiome
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- HALEON
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups
概览
简要总结
The aim of this 12-week clinical study is to evaluate the effect of a toothpaste containing sodium bicarbonate over time on the oral microbiome and to explore its effect in comparison to a regular fluoride toothpaste in participants with localized gingivitis.
详细描述
This will be a single-center, 12-week, randomized, controlled, single-blind (examiner only), two-treatment arm, parallel group design, clinical study investigating the effect of a toothpaste containing sodium bicarbonate on the oral microbiome in healthy adult participants with mild-moderate gingivitis. Approximately 55 participants (approximately 27 per group) will be randomized to ensure approximately 50 evaluable participants (approximately 25 per group) complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Participant's biological sex at birth was male or female.
- •Participant who, at the time of screening is aged 18-65 years, inclusive.
- •A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
- •A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •Participant with at least 20 natural, permanent teeth (excluding 3rd molars) and with at least 40 evaluable surfaces.
- •A healthy participant with mild to moderate gingivitis in the opinion of the clinical examiner.
排除标准
- •A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant who has any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- •A participant who is a pregnant female (self-reported) at screening or baseline visit or intending to become pregnant over the duration of the study or who is breastfeeding.
- •A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol (these will be added in the full protocol).
- •A participant who is a current smoker or an ex-smoker (including vaper) who stopped within 6 months of Screening.
- •A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- •A participant who is diagnosed with oral dryness or is taking any medication that in the view of the investigator is causing oral dryness.
研究组 & 干预措施
Test Toothpaste
Participants will be instructed to brush their teeth with the test toothpaste for at least one minute twice daily (morning and evening) for 12 weeks.
干预措施: Sodium Bicarbonate Toothpaste (Drug)
Reference Toothpaste
Participants will be instructed to brush their teeth with the reference toothpaste for at least one minute twice daily (morning and evening) for 12 weeks.
干预措施: Sodium Fluoride Toothpaste (Drug)
结局指标
主要结局
Change From Baseline in Bacterial Composition at Week 12 by Treatment Groups
时间窗: Baseline and Week 12
Taxonomic changes of microbial communities in plaque samples will be reported.
次要结局
- Change From Baseline in Potential Bacterial Activity at Week 12 by Treatment Groups(Baseline and Week 12)
- Differences in Bacterial Composition at Week 12 (Test Toothpaste Versus (Vs) Control Toothpaste)(Week 12)
- Differences in Bacterial Composition Between Different Areas of Plaque at Week 12(Week 12)