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临床试验/NCT06082609
NCT06082609Enrolling By Invitation不适用

Functional Relining Versus Digital Altered Cast Of Selective Pressure Impression Techniques Using Digitally Fabricated Distal Extension Frameworks: Abutment Alveolar Bone Height Changes

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
abutment alveolar bone loss

研究概览

简要总结

This clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes.

详细描述

According to the functional impression techniques, all patients will be classified into two equal groups:

Group A: Functional relining of processed RPD base at insertion:

•After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.The finished removable partial denture is relined using the functional relining impression technique.

Group B : Digitally obtained altered cast :

Selective pressure impression technique will be made.

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 (Participant)

入排标准

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

入选标准

  • •All patients having completely edentulous maxilla opposing class I Kennedy mandible.
  • •Sufficient restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.
  • •Well formed residual ridge covered by healthy firm mucosa.
  • •All patients are of angel's class I maxillo-mandibular relationships.
  • •Abutment teeth must fulfil certain criteria:
  • •Abutment teeth should be healthy with good periodontal and bone support.
  • •Should not show a pronounced degree of mobility or advanced gingival recession.
  • •Crown Root Ratio of abutment teeth not more than 1:2

排除标准

  • •Sever soft tissue undercuts.
  • •Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
  • •History of radiotherapy in the head and neck region.

研究组 & 干预措施

• Group 1 (Functional relining of processed RPD base at insertion)

Active Comparator
  • After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.
  • Registration of jaw relation.
  • Mounting of master casts on articulator.
  • Setting of artificial teeth according to lingualized occlusion principles.
  • Try in of RPD.
  • Flasking of RPD to obtain mandibular distal extension removable partial dentures.
  • The finished removable partial denture is relined using the functional relining impression technique.

干预措施: Removable partial denture (Procedure)

• Group 2 (Digitally obtained altered cast );

Active Comparator
  1. Construction of custom tray on metal frame work.
  2. Border molding of custom tray.
  3. Selective pressure impression technique will be made.
  4. Digital altered cast will be done according to J. Wu, Y. Cheng
  5. 3D printing of altered master cast that will be used for completing the construction of RPD with the same steps of group (A) but without relining.
  • Finally the occlusion of dentures in the two groups will be verified before delivery.

干预措施: Removable partial denture (Procedure)

结局指标

主要结局

abutment alveolar bone loss

时间窗: Two year

Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year

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

Asmaa Sdeek

Principal investigator

Mansoura University

研究点 (1)

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