Development of a Denture Cleanser Tablet: Evaluation of Antibiofilm Activity and Effects on the Constituent Surfaces of Removable Partial Dentures.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if a new experimental effervescent tablet works to clean removable partial dentures. It will test if the tablet lowers bacteria and fungi on denture surfaces. The main questions it aims to answer are: Does the experimental tablet lower the number of microbes on different denture materials? How happy are participants with the taste, odor, and cleanliness of the tablet? Researchers will compare the experimental tablet to a known commercial cleanser and to a neutral water solution to see which one works best. Total participation will last 70 days. First, researchers will place small material discs on the side of the participant's current denture to collect natural plaque. Participants will wear their dentures 24 hours a day and brush them with soap and water after meals. Participants will then cycle through three separate 14-day testing phases. In each phase, participants will soak their dentures daily for 15 minutes in one of the assigned solutions. Participants will also have a 7-day break between each phase where they return to their basic regular cleaning routine. At the end of each testing phase, researchers will remove the small discs to count the microbes in a laboratory. Participants will also answer a short survey about their satisfaction with each product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18 years or older.
- •Users of maxillary and/or mandibular removable partial dentures (RPD) made of acrylic resin.
- •Good systemic and oral health status, with enough healthy remaining teeth to support the RPD.
- •Agreement to follow the requested oral hygiene and denture cleaning protocols.
- •Ability to understand and sign the Informed Consent Form.
排除标准
- •Use of systemic antibiotics, antifungals, or anti-inflammatory drugs within the last 3 months.
- •History of allergic reactions to N-acetylcysteine (NAC), Melaleuca alternifolia (tea tree) oil, or components of the commercial positive control (NitrAdine).
- •Severe periodontal disease or extensive untreated caries in the remaining teeth.
- •Severe systemic diseases, immunodeficiency, or conditions that compromise manual dexterity to perform denture brushing.
- •Pregnant or lactating women.
研究者
Carolina Alves Freiria de Oliveira
PhD student
University of Sao Paulo
