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临床试验/NCT06201169
NCT06201169已完成不适用

Comparative Study of PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses

Amr Azab Abd El-Fattah4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
4
主要终点
Radiographically (digital periapical)

研究概览

简要总结

CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.

详细描述

Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.

研究设计

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

盲法说明

each participant enrolled in the study randomly and the results of both groups were serialized and assessed by the outcome assessor

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old.
  • and normal class Ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space

排除标准

  • All patient had systemic disorders that may influence soft or hard tissue healing were excluded as:
  • History of radiation therapy in the head and neck region.
  • Active infection or inflammation or flabby tissue in the mandibular arch
  • Bone diseases as osteoporosis.
  • Clenching or bruxism, temporomandibular joint troubles
  • Neurological or psychiatric handicap conditions that could interfere with good oral hygiene.
  • Heavy smoking and drug abusing

结局指标

主要结局

Radiographically (digital periapical)

时间窗: six and twelve months

marginal bone loss around the implants

次要结局

未报告次要终点

研究者

发起方
Amr Azab Abd El-Fattah
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amr Azab Abd El-Fattah

assiatant lecturer

Tanta University

研究点 (4)

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