A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
研究概览
简要总结
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.
详细描述
The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue [OST] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Aged between 18 and 85 years inclusive
- •Understands and is willing, able and likely to comply with all study procedures and restrictions
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
- •A qualifying full denture in both the upper and lower arch
- •Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6)
- •Dentures are well made (according to the well-made assessment)
- •Participants must report that they get food trapped under their denture
- •A peanut particle migration rating >0 for both dentures at screening
排除标准
- •Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
- •Women who are breast-feeding
- •Medications, which in the opinion of the investigator, would interfere with the conduct of the study
- •Taking or have taken a bisphosphonate drug for treatment of osteoporosis
- •A serious chronic disease requiring hospitalization
- •History of swallowing difficulties or choking
- •Any condition not previously mentioned that in the investigator's opinion may impair the study evaluation
- •Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •Known allergy to peanuts or any other nut
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- •Previous participation in this study
- •Recent history (within the last year) of alcohol or other substance abuse
- •OST examination findings such as stomatitis, open sores, lesions, redness or swelling
- •An employee of the sponsor or the study site or members of their immediate family
- •Any participant who, in the opinion of the Investigator, should not participate in the study.
研究组 & 干预措施
Reference Denture Adhesive
Participants applied reference denture adhesive as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth.
干预措施: Reference (Marketed) Denture Adhesive (Device)
Test Denture Adhesive
Participants applied test denture adhesive as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth.
干预措施: Experimental Denture Adhesive (Device)
No Adhesive (Negative Control)
Participants did not apply any denture adhesive in this treatment arm.
结局指标
主要结局
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
时间窗: Up to 17 days
Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).
次要结局
- Kapur (Olshan Modification) Index Scores for Denture Retention(Up to 17 days)
- Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive(up to 17 days)
- Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability(Up to 17 days)
- Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use(Up to 17 days)
- Kapur (Olshan Modification) Index Scores for Denture Stability(Up to 17 days)