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临床试验/NCT06514391
NCT06514391已完成不适用

Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture: A Study of Peri Implant Soft Tissue Health and Marginal Bone Loss

Mansoura University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Peri-implant marginal bone loss

研究概览

简要总结

this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. The evaluation will be done clinically and radiographically as following:

  • Marginal bone loss
  • Soft tissue changes around the implants

详细描述

Six patients of age ranging from 40 to 60years (mean 50 years) were selected for this study from the out patients clinic, Prosthodontics department, Faculty of Dentistry, Mansoura University.

I) Preparation of the patient for implant placement:

  1. A cone beam C.T was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants.
  2. Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement.

II) Surgical phase :

  1. Surgical stent was used to guide in implant placement. All implants were placed according to the flapless protocol under local anesthesia.
  2. All patients received four dental implants located anterior to the mental foramen in canine and premolar position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •They were healthy, free from any systemic diseases relating to the bone resorption such as uncontrolled diabetics or osteoprosis .This was achieved through medical history and clinical examination by physician.
  • •They have completely edentulous maxilla opposed by completely edentulous mandible
  • •All patients have sufficient inter-arch space for overdenture and milled bar construction not less than 12mm
  • •All patients are of Angel's class I maxillo-mandibular relationship.
  • •All patients must have mandibular bone height interforaminally not less than 8-10 mm as verified by cone beam C.T.

排除标准

  • •Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases, hyperparathyroidism
  • •Uncontrolled diabetes mellitus
  • •Severe osteoporosis
  • •Recent organ transplants, long-term corticosteroid use
  • •Radiotherapy
  • •Uncooperative patients with psychiatric disorders
  • •Heavy smokers
  • •Poor oral hygiene
  • •Parafunctional habits

研究组 & 干预措施

compressive one piece implants with bar attachment

Experimental

All patients received 4 mandibular inter-foraminal single piece compressive implants, bar attachment connecting 4 implants was then cemented and complete mandibular overdenture was attached to bar via peek clips

干预措施: compressive single piece dental implant (Procedure)

结局指标

主要结局

Peri-implant marginal bone loss

时间窗: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan

次要结局

  • Peri-implant soft tissue health(at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12))

研究者

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

Mohamed shady

Assistant Professor

Mansoura University

研究点 (1)

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