A Study to Determine the Efficacy of a Denture Adhesive Formulation to Seal Out Food Particles From Under the Mandibular Partial Denture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Poppy Seed Count Before Treatment Application
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •give written informed consent prior to their participation;
- •be 18 years of age or older;
- •have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis;
- •have a history of food particles getting under their partial, mandibular denture;
- •agree not to use any denture adhesive on the day of their study visits, prior to the visit;
- •agree to not participate in any other oral/dental product studies during the study;
- •be willing to use or not use denture adhesive as instructed during the treatment periods;
- •be willing to eat a poppy seed muffin;
- •be in good general health as determined by the Investigator/designee based on a review of the medical history/update; and
- •have a minimum of 4 total poppy seeds on their mandibular denture base and gingiva after eating the muffin.
排除标准
- •present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study;
- •self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or
- •have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures:
- •have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
结局指标
主要结局
Poppy Seed Count Before Treatment Application
时间窗: Immediately following consumption of the muffin before treatment application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
Poppy Seed Count After Treatment Application
时间窗: Immediately following consumption of the muffin after treatment application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
次要结局
未报告次要终点