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临床试验/NCT03038737
NCT03038737Unknown不适用

Comparative Study Of Biting Force Of Injection Molded PEEK and Bre.Flex Materials For Bounded Removable Partial Dentures (Randomized Clinical Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2017年3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
change in Biting force

研究概览

简要总结

The aim of the present study is to evaluate the biting force of upper removable partial denture constructed from two different flexible thermoplastic materials.

详细描述

The patient will be treated in visits designated as follows:

Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their alveolar bone support of abutment) and primary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts .

Visit 2: Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the interarch distance and occlusal plane.

Visit 3: primary surveying is performed. Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats will be prepared opposing to the edentulous area. Final impression will be taken by elastomeric impression material. The impression will be poured into type IV dental stone in order to obtain master cast. The master cast will be surveyed. The proposed design will be as follows: metal framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention.

Visit 4: the metal framework is tried into the patient's mouth. Jaw relation is recorded.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •i. All patients must have Kennedy class III modification I upper partially edentulous ridges.
  • •ii. The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
  • •iii. Male or female patient with age range (45-55) and in good medical condition iv. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
  • •v. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • •vi. Free from any tempro-mandibular joint disorder. vii. The patients have good oral hygiene and low caries index.

排除标准

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

研究组 & 干预措施

group 1

Active Comparator

patients will receive partial denture constructed from breflex material

干预措施: bre.flex (Other)

group 2

Experimental

patients will receive partial denture constructed from PEEK material

干预措施: PEEK (Other)

结局指标

主要结局

change in Biting force

时间窗: 1 month

the change in biting force will be recorded three times. The first week at the time of insertion measuring the biting force immediately after partial denture insertion. The third week measuring biting force of the partial denture. The fourth week measuring biting force of the partial denture. the biting force will be measured by I-load sensor.

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

Arwa Mabrouk Ayad Issa

principal investigator

Cairo University

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