Outcomes of Interventions for Patients With a Reduced Posterior Dental Arch: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
Dental services for large sectors of the population of the Western Cape (WC) Province of South Africa (SA) has been, and continues to be, limited to low-cost treatment options and emergency services, such as extractions at public health clinics. Replacement of missing teeth for the disadvantaged majority of the population is provided almost exclusively at the dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result of disease and the lack of restorative care and then having these replaced by a removable partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and quality of life of partially dentate adult patients with a reduced posterior dental arch and /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the posterior teeth with a removable prosthesis.
详细描述
The aim of this research is to determine whether the daily functional needs and the quality of life of partially dentate adult patients with a reduced posterior dental arch will be satisfied and improved without having the posterior teeth replaced with a removable prosthesis, as compared to having the use of such prosthesis.
Objectives: To conduct a randomized controlled trial amongst partially dentate adult patients with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and where these patients will be randomly assigned to one of two groups: one group would be provided with a metal- based removable partial denture (RPDP) to replace the posterior teeth, the other will receive no treatment.
Daily functioning ability and patient satisfaction between the groups (with/without RPDP) would then be compared.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Classic SDA
- •Patients with a reduced posterior dental arch (from 3-5 posterior occluding teeth)
- •Specific Age limits
- •Remaining teeth periodontally sound
- •Lost molars in one jaw
- •Both canines and one premolar should be present
排除标准
- •Exclude patients with Angle Class 2 or 3
- •Signs of Temporo-mandibular disorders
- •Compliance is a problem (Alcoholism/ drug addiction)
- •Risk of over-eruption of teeth
- •Patients wanting removable partial dentures
结局指标
主要结局
Patient satisfaction
时间窗: 3 months
Two different tools will b used to assess primary outcomes 1. Oral Impact of Daily Performance (OIDP) tool 2. Global Visual Analogue Scale (VAS)
次要结局
- Functioning(3 months)
- Oral health-related Quality of Life(3 months)
研究者
Dr Saadika Khan
Dr
University of the Western Cape