Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Removable Partial Denture (RPD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Survival of the prosthesis
研究概览
简要总结
The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin removable partial denture used in partial edentulous rehabilitation after one year of follow-up. The main question it aims to answer is:
- What is the survival outcome of partial rehabilitations using Poly-ether-ether-ketone-acrylic resin removable partial dentures? The participants will receive a definitive removable partial denture incorporating Poly-ether-ehter-ketone.
详细描述
Folowing the recent applications of polyetheretherketone (PEEK) material in Dentistry it is necessary to further extend the evaluation to the use of Removable Partial Denture (RPD) rehabilitations. To test this, the study design to be used will be a single-centre, prospective observational cohort study to evaluate the short term outcome of the Removal Partial Denture (RPO) supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated at baseline, RPD design, dental fitting, follow-up assessment at 4 weeks, 6 and 12 months after dental loading regarding: JUVORA prosthetic survival including repair and relining, assessment of the adaptation of the RPD frame, adaptation of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetics assessment (staining, color stability, anatomic form), oral health assessment of the RPD abutment teeth periodontium (plaque index, gingival index, probing pocket depths, bleeding on probing, mobility) incidence of mechanical complications (loosening or fracture of prosthetic components), patient assessment of RPD comfort, aesthetics and chewing ability; assessment of RPD preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •partial edentulism with at least a posterior natural tooth occlusaI stop (molar or premolar), defined as Kennedy's Class I, Class lI or Class lII,
- •occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest;
- •previous denture wearing experience,
- •stable oral health in terms of absence of disease activity affecting the periodontium, caries, pulp and the structural/aesthetic integrity of restored teeth.
- •Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
排除标准
- •Female Subjects who are pregnant;
- •Subjects requiring extensive treatment prior to the provision of a removable partial denture;
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;
- •Subjects who are currently enrolled in a clinical study;
- •Subjects requiring or currently having ongoing orthodontic treatment;
- •Subjects with an opposing Removable Partial Denture (RPD).
结局指标
主要结局
Survival of the prosthesis
时间窗: one year
Evaluation of the survival for the PEEK-acrylic resin removable partial denture; nominal (survival,failure)
次要结局
- Function of RPD is excellent(one year)
- Color stability is maintained(one year)
- Incidence of mechanical complications(one year)
- Incidence of biological complications(one year)
- Oral Health Impact Profile OHIP-14(one year)
- Assessment of the adaptation of the RPD frame(one year)
- Probing pocket depths around RPD Dependent variable abutment teeth measured in millimeters(one year)
- Staining of RPD is absent(one year)
- Anatomic form of RPD is maintained(one year)
- ln mouth comfort(one year)
- Plaque accumulation around RPD abutment teeth.(one year)
- Bleeding around RPO abutment teeth(one year)
- Aesthetics of RPD are excellent(one year)
- Mobility of RPO abutment teeth(one year)