Complete Denture Palatal Material Impact on Patients' Satisfaction and Oral Health-Related Quality of Life: a Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patients' reported overall satisfaction with their dentures
研究概览
简要总结
Conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. A randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. The study aimed to determine whether an acrylic palate would provide better sensory feedback and improved oral function. Participants wore each denture and completed a questionnaire. The study's results have implications for the design of complete dentures, as they highlight the importance of considering patient experiences and feedback when selecting materials. By prioritizing patient satisfaction and oral health-related quality of life, dental professionals can enhance denture treatments' effectiveness and improve patients' quality of life.
详细描述
Conventional dentures have long been criticized for their discomfort and limitations in oral functionality, primarily attributed to the polished surfaces covering the palate and rugae areas. To address these concerns, a rigorous randomized crossover clinical trial was meticulously conducted to compare the subjective experiences of patients wearing dentures with either an acrylic or metal palate.
The primary objective of this study was to evaluate patients' satisfaction and oral health-related quality of life while wearing dentures with different palate materials. Specifically, researchers sought to ascertain whether the use of an acrylic palate could offer superior sensory feedback and enhance overall oral function compared to traditional metal palates.
Participants enrolled in the study were required to wear both types of dentures consecutively and subsequently complete a comprehensive questionnaire designed to capture their subjective experiences and perceptions. The questionnaire encompassed various aspects, including comfort, ease of speech, ability to chew and swallow, and overall satisfaction with the dentures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not be aware of which group he/she is interviewing at the assessment session.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Minimum Age: 45 Years Maximum Age: 80 Years Sex: All Gender-Based Inclusion: No Accepts Healthy Volunteers: Yes (if completely edentolous)
- •Inclusion Criteria:
- •Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, either for the first time or as a replacement for previous dentures
- •Patients aged between 45 and 80 years old
- •Completely edentulous for at least 3 months
- •Patients who approved and consented to participation
排除标准
- •Patients with severe underlying medical conditions, including: Neuromuscular dysfunction, Auditory problems, Mental conditions, Oral pathology, Xerostomia, Tied tongue condition
- •Patients who met the inclusion criteria but failed to sign a consent form
研究组 & 干预措施
Acrylic palate complete denture
Participants will receive maxillary complete dentures with an acrylic palate
干预措施: Complete denture with a metallic Co-Cr casted palate (Other)
Metal palate complete denture
Participants will receive maxillary complete dentures with a metal palate
干预措施: Complete denture with an acrylic palate (Other)
结局指标
主要结局
Patients' reported overall satisfaction with their dentures
时间窗: 60 days
Patients overall satisfaction rate using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').
次要结局
- Patients reported oral health related quality of life(60 days)
- Patients' reported overall satisfaction with their dentures during speaking.(60 days)
- Patients' reported overall satisfaction with their dentures during eating(60 Days)
- Patients' reported overall satisfaction with their dentures during drinking(60 Days)
- Patients' reported overall satisfaction with their ability to clean their dentures(60 Days)
- Patients' reported overall satisfaction with their phonetics(60 Days)
研究者
Motasum Abu-Awwad
Associate Professor
University of Jordan