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临床试验/NCT05622448
NCT05622448已完成不适用

Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
patient satisfaction

研究概览

简要总结

To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.

详细描述

The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).

Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the abutments.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
  • •Opposing dentition is fully intact or restored.
  • •Sufficient inter-arch space.
  • •Angle's class I maxilla-mandibular relationship.

排除标准

  • •Periodontal affection of the abutment teeth.
  • •Skeletal mal-relation.
  • •Unmotivated patients to maintain adequate oral hygiene to follow up.
  • •Patients with neuromuscular and Psychiatric disorders.
  • •Systematic disease affecting bone and periodontal health.
  • •Insufficient inter-arch space.
  • •Patients with physical reasons that could affect follow up.

研究组 & 干预措施

RPD with metallic framework

Active Comparator

removable partial denture with cobalt chromium framework

干预措施: RPD with PEEK framework (Other)

RPD with metallic framework

Active Comparator

removable partial denture with cobalt chromium framework

干预措施: RPD with metallic framework (Other)

RPD with PEEK framework

Experimental

removable partial denture with poly ether ether ketone framework

干预措施: RPD with PEEK framework (Other)

RPD with PEEK framework

Experimental

removable partial denture with poly ether ether ketone framework

干预措施: RPD with metallic framework (Other)

结局指标

主要结局

patient satisfaction

时间窗: From enrollment to the last follow up

Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q. likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)

Oral Health Related quality of life

时间窗: From enrollment to the last follow up

次要结局

  • Marginal bone changes.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arwa Sedky Abd El-lateef

doctor

Cairo University

研究点 (1)

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