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临床试验/NCT03507153
NCT03507153Unknown不适用

Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek (Randomized Clinical Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Muscular activity

研究概览

简要总结

Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Only statistician will be blinded as the 2 materials have different colors The patients: they won't be aware of the lab procedures till finishing and delivery of the dentures.

The outcome assessor: the assessor who will assess the muscular activity will be blinded.

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients must have Kennedy class III modification I upper partially edentulous ridges.
  • The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
  • All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
  • Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • Free from any tempro-mandibular joint disorder.
  • The patients have good oral hygiene and low caries index.

排除标准

  • Patients having abnormal habits as bruxism or clenching.
  • Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
  • Teeth with compromised bone support.
  • Patient with xerostomia or excessive salivation.
  • Patient with abnormal tongue behavior and/or size.

研究组 & 干预措施

Bre-fllex group

Active Comparator

Maxillary class III modification I edentulous patients that will recieve Bre-flex partial denture

干预措施: Bre-flex maxillary partial denture (Procedure)

PEEK group

Experimental

Maxillary class III modification I edentulous patients that will recieve PEEK partial denture

干预措施: PEEK maxillary partial denture (Procedure)

结局指标

主要结局

Muscular activity

时间窗: one month

Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.

次要结局

未报告次要终点

研究者

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

ahmed salama sayed tantawy

Principal Investigator

Cairo University

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