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临床试验/NCT03253510
NCT03253510Unknown不适用

Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9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
24
试验地点
1
主要终点
Biting force

研究概览

简要总结

Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA

详细描述

Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
  • •Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
  • •Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • •Free from any tempro-mandibular disease.
  • •Good oral hygiene

排除标准

  • •Neuromuscular disorder and orofacial disease.
  • •Tempromandibular joint and muscle pain
  • •xerostomia or excessive salivation.
  • •Limited mouth opening
  • •Abnormal tongue behavior and/or size.
  • •Intraoral soft and hard tissue pathosis

研究组 & 干预措施

Poly-amide

Experimental

new thermoplastic material used as a denture base, that has excellent ethetics and flexibility

干预措施: Poly-amide (Other)

poly-methyl methacrylate

Active Comparator

Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability

干预措施: Poly-methyl methacrylate (Other)

结局指标

主要结局

Biting force

时间窗: One month

Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force.

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

Hadeer Hadi

Master degree candidate at removable prosthodontic department, Cairou

Cairo University

研究点 (1)

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