A Single-centre, Randomised, 3-way Cross-over, Clinical Investigation Comparing Denture Fixative Versus no Fixative Performance in Full Denture Wearers and an Exploratory Substudy in Partial Denture Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Denture Retention Assessment at 1hour
研究概览
简要总结
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
详细描述
A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.
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
- Single (Outcomes Assessor)
盲法说明
Masking versus no fixative control will not be possible, however, clinical outcomes assessors will be masked to the two different investigational denture fixative products
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
- •Participants with a completely edentulous maxillary [UPPER] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular [LOWER], which may be restored with a stable complete, partial or implant supported denture
- •For complete denture wearers, maxillary [UPPER] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)
- •Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
- •Participants must have been using dentures daily for at least 6 months prior to the screening visit
- •Dentures must have been made in the last 5 years;
- •Dentures must be well-made based on design and construction in the opinion of the clinician
- •No clinically significant and relevant abnormalities in medical history or upon oral examination
排除标准
- •Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
- •Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •Any clinically significant or relevant oral abnormality (e.g., temporomandibular joint [TMJ] problems), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study
- •Participants with maxillofacial defects covered by prosthetics
- •Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator
- •Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy
结局指标
主要结局
Denture Retention Assessment at 1hour
时间窗: 1 hour after denture fixative application or no fixative control
To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
次要结局
- Denture Retention Assessment at 5minutes and 30minutes(5mins and 30 mins after denture fixative application or no fixative control)
- Denture Stability at 5minutes, 30minutes and 1hour(5mins and 30 mins after denture fixative application or no fixative control)
- Gum Comfort Assessment(At the end of each participant's day during the 4-day treatment period for each arm)
- Denture Hold Assessment(≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control)
- Participant Satisfaction Assessment(At the end of each participant's day during the 4-day treatment period for each arm)
- Bite Force Assessment(To be completed once during the participant's clinic visit on days 3, 5 and 7)
- Oral Health Assessment(To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative)