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临床试验/NCT06720389
NCT06720389已完成不适用

Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures: a 3-year Prospective Radiographic Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月12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
20
试验地点
1
主要终点
peri implant bone loss

研究概览

简要总结

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

详细描述

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

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
Single (Investigator)

入排标准

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

入选标准

  • •All patient wearing maxillary conventional denture.
  • •All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
  • •A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
  • •They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
  • •At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
  • •All patients are of angel's class I maxillo-mandibular relationships.

排除标准

  • •Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
  • •Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
  • •Long term immunosuppress and corticosteroid drug therapy.
  • •Patient with abnormal habits as clenching and bruxism.
  • •Smoking patient.
  • •Uncooperative patients.
  • •Neuromuscular diseases.
  • •Patient with problems in TMJ.

研究组 & 干预措施

milled mandibular overdenture opposed by maxillary complete denture

Active Comparator

A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD).

干预措施: peri implant bone loss was assessed by CBCT (Radiation)

milled mandibular overdenture opposed by maxillary complete denture

Active Comparator

A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD).

干预措施: posterior ridge resorption was assessed by CBCT (Other)

3D-Printed mandibular overdenture

Active Comparator

The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base.

干预措施: peri implant bone loss was assessed by CBCT (Radiation)

3D-Printed mandibular overdenture

Active Comparator

The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base.

干预措施: posterior ridge resorption was assessed by CBCT (Other)

结局指标

主要结局

peri implant bone loss

时间窗: at baseline (T0), at1 year(T1), at 3 years(T3)

peri implant bone loss was assessed by CBCT

posterior ridge resorption

时间窗: at baseline (T0), at 1 year( T1), at 3 years (T3).

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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