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临床试验/NCT03127033
NCT03127033Unknown不适用

Patient Satisfaction of Soft Liner Versus Acrylic Resin Telescopes in Complete Overdenture Patients With Ectodermal Dysplasia: Non-Randomized Clinical Trial

Cairo University0 个研究点目标入组 6 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
6
主要终点
Patient Satisfaction

研究概览

简要总结

Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after delivery and after 3 months Patient satisfaction, retention and periodontal condition will be assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be replaced with soft liner and again Patient satisfaction, retention and periodontal condition will be assessed a week after delivery and 3 months later.

详细描述

Upper and Lower Primary impressions will be carried out by using irreversible hydrocolloid (Alginate, Tropicalgin, Normal setting, Zhermack, Italy) according to manufacturer's instructions using stainless steel stock trays.

Secondary upper impression is done with an acrylic special tray. Border molding is done with putty consistency rubber base impression material, Final impression with medium consistency rubber-base impression material (Silicone impression material, Elite P&P, Regular Body-Normal set, Zhermack, Italy) Maxilla-mandibular relationship will be recorded using check bite technique. Setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth.

The finished and polished dentures will be delivered immediately after the necessary occlusal adjustments and instructions regarding hygiene and maintenance.

The patient will use the upper overdenture for 3 months. The overdenture is taken from the patient for two weeks, after which the maxillary overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium.

The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Partially edentulous ectodermal dysplasia patients with few remaining teeth.
  • •Cooperative patients with no history of psychological diseases.
  • •Length of maxillary remaining teeth should not be less than 4mm.

排除标准

  • •- 1- Patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • •2- Patients allergic to acrylic resin.

结局指标

主要结局

Patient Satisfaction

时间窗: 3 months

A questionaire will be given to the patient to assess thier denture satisfaction in numerical data using Visual Analogue Scale

次要结局

  • Retention(3 months)
  • Gingival index(3 months)
  • Probing depth(3 months)
  • Tooth mobility(3 months)
  • Absence or presence of inflammation(3 months)

研究者

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

Yasmine Hisham Abd El rahman Mohsen

Principal investigator

Cairo University

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