The Effect of Using Denture Adhesives on Patient Satisfaction With Complete Dentures; A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- oral health impact profile for edentulous patients (OHIP-EDENT)
研究概览
简要总结
The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial.
The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients
详细描述
Aims: The aims of this study is to compare patient satisfaction and oral health quality of life without using denture adhesive and using 3 types of denture adhesives.
Materials and Methods
60 completely edentulous patients attending the University of Jordan hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20). At delivery of complete dentures, all patients will be given the dentures with no denture adhesive and will be given review appointments after one month of using the dentures. At review appointment, patients will be asked to rate their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive (OF). Patients will be given instructions on how to use each type of adhesive and will be provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill out the same forms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients seeking new conventional complete dentures for first time
- •Patients aged 40-85 years
- •Must be completely edentulous for at least 6 months
- •Must have well-developed to moderately resorbed maxillary and mandibular ridges
- •Must have no denture fissuratum or any traumas from previous dentures
- •Must be able to complete and sign the consent form
排除标准
- •Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
- •Patients with oral pathology, xerostomia, or tied tongue condition.
结局指标
主要结局
oral health impact profile for edentulous patients (OHIP-EDENT)
时间窗: I month after denture delivery
20 aspects linking the dentures with patient quality of life, with a range of values from 1 to five for each aspect, with 1 being the best and 5 being the worst.
Patient satisfaction form
时间窗: 1 month after denture delivery
10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied
次要结局
未报告次要终点
研究者
Dr. Nadia Ereifej
Associate Professor
University of Jordan