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临床试验/NCT07284680
NCT07284680进行中(未招募)不适用

Bio-implant Root Analogue Versus Conventional Screw-type Implant for Management of Pier Abutment in Mandibular Distal Extension Cases

Mansoura University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年12月19日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8
试验地点
1
主要终点
bone changes and soft tissue changes

研究概览

简要总结

reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and compare the bioimplant root analogue implant with the conventional screw type implant the evaluation was done 0,3 and 6months of definitive prosthesis insertion regarding the following

  1. radiographic evaluation of the alveolar bone hight as related to the bio implant ,conventional screw implant , pier abutment and RPD abutments : this will be done using standardized periapical digital radiographs
  2. soft tissue evaluatins related to the bio implant ,conventional screw implant , pier abutment and RPD abutments this will be done using : A . modified plaque index (MPI) B . modified gingival index (MGI) C . peridontal pocket depth

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, 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

入选标准

  • The patients had bilateral mandibular free-end partially edentulous cases with a pier abutment or a planned presence of pier abutment.
  • The edentulous space mesial to the pier abutment has a hopeless tooth or root that was used for bio-implant insertion or conventional screw-type implants.
  • Healthy patients with no systemic disease that can affect the implant surgery. This was verified by medical history in addition to a report from the physician.
  • The patients have had dentulous maxillary jaw and mandibular free-end saddle for at least 6 months.
  • Class I maxillo-mandibular relationship with adequate inter-arch distance.

排除标准

  • Patients with metabolic disorders that affect osseointegration such as uncontrolled diabetes mellitus, immune disorders, and osteoporosis.
  • Patients with heavy smoking habit
  • Patients complaining of severe temporomandibular joint disorder.

结局指标

主要结局

bone changes and soft tissue changes

时间窗: after 3 and 6 months of denture insertion

peri-implant bone and soft tissue changes and abutment teeth bone and soft tissue changes changes periapical X-ray for measurement of bone changes by millimeter periodontal probe for measurement of soft tissue changes by millimeter

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

Hosam eldin Hegazy Mohamed Ebrahim Eid

postgrad student (master of prosthodontics)

Mansoura University

研究点 (1)

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