NCT02401360已完成不适用
A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
Procter and Gamble0 个研究点目标入组 106 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- Gingivitis
研究概览
简要总结
This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •give written informed consent prior to their participation;
- •be 18 to 65 years of age at the time of enrollment;
- •agree not to participate in any other oral/dental product studies;
- •agree to delay any elective dentistry (including a dental prophylaxis);
- •agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
- •agree to return for the scheduled visits and follow study procedures;
- •be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
- •have more than 10 bleeding sites at visits 1-3
- •Consistency of bleeding site number at baseline may be considered;
- •have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
- •refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.
排除标准
- •teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
- •antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
- •medical conditions that the investigator considers significant and that may compromise the evaluation of study results
- •currently participating in any other clinical trial
- •participated in a clinical trial for plaque/gingivitis within the previous 30 days
- •pregnant or lactating
- •orthodontic appliances or removable partial dentures
- •soft or hard tissue tumor of the oral cavity
- •advanced periodontal disease
- •history of hepatitis, diabetes, or other communicable diseases
- •history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •history of significant adverse effects following the use of oral hygiene products such as toothpaste
- •oral pathoses that could interfere with compliance and/or examinations or that need treatment.
研究组 & 干预措施
Experimental Group
Experimental
Oral care regimen
干预措施: China Crest® Pro-health 7 Complete Toothpaste (Drug)
Control Group
Placebo Comparator
Toothbrush and toothpaste
干预措施: China Crest® Cavity Protection Toothpaste (Drug)
结局指标
主要结局
Gingivitis
时间窗: Day 24
Gingivitis was assessed according to the Gingival Bleeding Index
次要结局
- Plaque Examination(Day 24)
研究者
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