Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of the change in the retention within each type of complete denture.
研究概览
简要总结
This study investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials.
详细描述
All patients will be randomly allocated to two equal groups either with the protocol I or II (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the group with the protocol II will use the unmodified dentures during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of retention will be done immediately and 1 month after denture insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients requiring new removable complete dentures, with class I edentulous arches based on the American College of Prosthodontists (ACP) classification15, with an average age of 45-55 years old, with healthy temporomandibular joint, being without systemic disease that could affect the neuromuscular control or salivary flow
排除标准
- •Patients with ACP Class II, III, or IV, and xerostomia.
结局指标
主要结局
Assessment of the change in the retention within each type of complete denture.
时间窗: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.
It is measured in Newton.
次要结局
未报告次要终点
研究者
Amr Gamal Ismail Mohamed
Dr
Cairo University