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临床试验/NCT02178384
NCT02178384已完成不适用

An In-vivo Study to Evaluate Three Methods of Managing the Distribution of Loading Forces in Mandibular Distal-extension Prostheses (Class I Kennedy's Classification)

Damascus University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Soft-tissue vertical displacement (STVD)

研究概览

简要总结

The two structures that support a mandibular distal extension removable partial denture differ markedly in their visco-elastic response to loading. The difference between the resilience of the residual ridge tissues and the teeth permitted by the periodontal ligament presents a disparity of support that is in contrast to the uniform support accorded a tooth-supported removable partial denture. Hence the denture tends to rotate about its most distal abutments, inducing heavy torsional stresses on alveolar ridges.

Many methods have been used to control this movement, some of them:

  1. Implant support on distal extension removable.
  2. Stress breakers provide a mean of interposing a flexible connection between the tooth-borne retainer portion of removable partial denture and its distally extended tissue-borne segment.
  3. Altered-cast technique.
  4. Design development by using mesial indirect retainers rather than distal ones.

The purpose of this study is: (1) to compare bone absorption around abutment teeth nearby the free saddle; (2) denture displacement and pressure on the soft tissue under the denture base of distal extension RPD (Removable Partial Denture) (3) cellular changes in the soft tissue under the denture base of distal extension RPD.

详细描述

Removable partial dentures (RPD) have an essential role in treating partly edentulous. patients with large toothless spaces, or without posterior dental support (Kennedy Class I).

Rehabilitation with Distal-Extension Removable Partial Denture (DERPD) deserves special attention because of the difference in resilience between the remaining mucosa of the edentulous area and the periodontal ligament of the abutment tooth. When occlusal forces affect the bases, the difference in resilience between the mucosa of the edentulous area and the periodontal ligament of the abutment teeth creates a rotating movement whose axis is located on the occlusal rests on the abutment teeth. This may induce horizontal forces and mainly lateral forces upon them, causing inflammation, gingival retraction, increase in dental mobility and distal residual ridge resorption. This movement may cause a reduction in function, discomfort and trauma to the RPD supporting tissues.

MATERIAL AND METHODS:

Patients will be recruited from the Department of Prosthodontics at the University of Damascus Dental School. Thirty patients will be randomly divided into three groups (A, B, and C). A mandibular bilateral distal-extension removable partial denture will be used for patients in all groups. But every group will have its own specific method of distributing loading forces.

In Group A: A Removable partial dentures will be made by using altered-cast technique for free saddle.The investigators will make a primary impression using stock tray. This will be followed by a final impression by individual tray. After metal framework try-in, ridge regions are removed from uncorrected master cast with saw. Then, corrective impression of ridges will be obtained with soft ZOE impression paste. Therefore, a metal framework with associated corrective impression will be repositioned on tooth portion of master cast prior to altering distal-extension bases.

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
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bilateral distal extension in the mandible (Class I Kennedy's Classification).
  • Stable systemic health, including absence of a history of cardiovascular disease.
  • No evidence of infection or trauma in the oral region.
  • Negative history of syndromes or temporomandibular disorders and parafunction.

排除标准

  • Other Classes of Kennedy's Classification
  • Patients with ages beyond the accepted age range.

结局指标

主要结局

Soft-tissue vertical displacement (STVD)

时间窗: This variable will be measured at one month, three months and six months following appliance first delivery

Soft tissue vertical displacement will be measured using an impression technique at the free end saddles.

次要结局

  • Bone absorption of abutment teeth(This variable will be measured at one month, three months and six months following appliance first delivery)
  • Cellular changes of the supporting tissues(This variable will be measured at one month, three months and six months following appliance first delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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