A Randomized, Single-Blind, Clinical Study to Assess Food Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, Edentulous Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures
研究概览
简要总结
The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.
详细描述
This is a single center, controlled, single-blind, randomized, two-treatment, two-period, cross-over design in participants with full upper and lower dentures. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by weight) to the dentures in a pattern of continuous strips which will be applied to upper and lower denture and will be then placed in mouth and participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 2 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with water, the dentures will be removed, and any peanuts that have been migrated under each denture will be collected and weighed after a drying process. Participants will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The number of denture dislodgments reported by the participants during the chewing of the peanuts will also be collected and analyzed and this, and the questionnaire data, will be used to support the findings of the peanuts mass measure.
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
- 否
入选标准
- •Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Participant is male or female who, at the time of screening, is between the ages of 18 and 85 years, inclusive.
- •Participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
- •Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •Self-reports experience of getting food trapped under their denture.
- •Is a habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
- •Have denture protheses that fulfil all of the following: a) A qualifying conventional acrylic full denture in both the upper and lower arch; b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6) with no individual stability or retention scores <1; c) Dentures are well made (according to the well-made assessment); d) Has a peanut particle migration rating >0 for each denture.
排除标准
- •A Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- •A Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the Participant inappropriate for entry into this study.
- •A Participant who is a pregnant female (self-reported).
- •A Participant who is a breastfeeding female.
- •A Participant with known or suspected intolerance or hypersensitivity to the study materials(or closely related compounds) or any of their stated ingredients.
- •A Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
- •A Participant unwilling or unable to comply with the Lifestyle Considerations such as a) During the entire study Participants will not be permitted to have any dental/denture work performed during the time they are in the study, unless discussed and permitted by the examiner. This is to assure that the denture fit will not be altered during the study; b) During the treatment visits Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing and Participants will not be allowed to use tobacco or nicotine or nicotine-containing products following denture insertion until after their dentures are returned at completion of the food occlusion testing.
- •History of swallowing difficulties or choking.
- •Currently taking or have taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
- •Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the Participant's participation in the study.
- •Known allergy to peanuts or any other nut.
- •Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
- •Recent history (within the last year) of alcohol or other substance abuse.
- •Oral soft tissue examination findings such as stomatitis, open sores, lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study or the safety of the Participant.
- •Use of any medication that, in the opinion of the investigator, would interfere with the conduct of the study.
- •A serious chronic disease requiring intermittent hospital visits.
- •Having been previously enrolled in this study.
- •Any participant, in the opinion of the investigator, who should not participate in the study.
结局指标
主要结局
Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures
时间窗: Upto 16 days
On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.
次要结局
- Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture(Upto 16 days)
- Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture(Upto 16 days)
- Number of Denture Dislodgements During Chewing as Reported by Participants(Upto 16 days)
- Mean Scores From Participant Completed Questionnaire(Upto 16 days)