Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in patient-reported outcome measures (PROM)
研究概览
简要总结
In this study the additional effect of supplementary implants in patients with Kennedy Class I in terms of patient-reported outcome measures (PROMs) and cost-benefit-analyses comparing costs of maintenance care will be investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have voluntarily signed the informed consent before any study action, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
- •Males and females with at least 18 years of age
- •intraoral situation with bilateral edentulous areas located posterior to the remaining natural teeth (Kennedy class I) in the upper or lower jaw
- •remaining dentition includes a first premolar, canine or incisor as the most posterior tooth
排除标准
- •Uncontrolled systemic disease that would interfere with dental implant therapy;
- •Patients who smoke > 10 cigarettes per day or tobacco equivalents;
- •Patients with alcohol and/or drug abuse;
- •Patients with chronic pain;
- •Patients with untreated periodontitis and / or inadequate oral hygiene (Plaque Index < 30%);
- •Medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment;
- •Conditions or circumstances, in the opinion of the investigators, which would prevent completion of study participation or interfere with analysis of study results such as history of non-compliance or unreliability.
结局指标
主要结局
Changes in patient-reported outcome measures (PROM)
时间窗: assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)
Assessment of patient's perception of function and oral health comparing conventional RPDs to implant-supported RPDs with and without retentive components in posterior sites of Kennedy Class I. PROMs are evaluated using the Oral Health Impact Profile (OHIP 14), i.e. the short form of OHIP with 14 items measuring oral health-related quality of life (OHQoL). The frequency of impairment in different areas (functional limitation, physical discomfort or disability, psychological discomfort or disability, social disability, and handicap) are indicated on a multi-level scale ("never"=0, "hardly"=1, "sometimes"=2, "often"=3, "very often"=4)
Changes in chewing efficiency
时间窗: assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)
Assessment of the chewing Efficiency by masticating standardized fruit gum with three varying degree of hardness. A complete chewing function test comprises 9 chewing sequences: the different hardness of the model food is chewed once on the right, then on the left and finally on both sides. The study participants have 30 seconds for each chewing sequence and 30 seconds between each chewing sequence. Only one fruit gum is chewed per chewing sequence. The samples are placed on a defined area, photographed in standardized manner and analyzed with a computer program. The mean size and amounts of the chewed particles are calculated and determines the chewing efficiency
次要结局
- prosthetic and implant survival rates(during follow-ups, 1 of 5 years after implant placement)
- Evaluation of success of entire treatment(during follow-ups, 1 of 5 years after implant placement)
- cost-benefit-analyses(during follow-ups, 1 of 5 years after implant placement)