NCT07575997招募中不适用
A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.
详细描述
This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.
3 visits are planned:
- Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally
- Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth)
- Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged between 18 and 80 years included
- •Subject having signed his/her written informed consent for his/her participation in the study
- •Subject diagnosed with active generalized periodontal disease (excluding gingivitis)
- •Subject having at least 20 natural teeth (10 teeth on each side (right and left))
- •Non-inclusion criteria:
- •Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire
- •For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
- •Subject having any other oral condition than periodontal disease (ex: dermatologic ulcers), or any orthodontic conditions liable to interfere with the study assessment or considered by the investigator hazardous for the subject or incompatible with study requirements
- •Systemic treatment or topical treatment/product currently taken/applied in the mouth liable to interfere with study assessments according to the investigator or planned to be taken/applied during the study
- •Subject has received periodontal therapy (scaling, root planing, surgery, etc.) within 2 months before the inclusion
- •Subject who has undergone oral or gum surgery within 2 months before the inclusion, or planned to be performed during the study
排除标准
- 未提供
研究者
研究点 (1)
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