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临床试验/NCT06520280
NCT06520280进行中(未招募)不适用

Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture Bases Construction Techniques: an in Vivo Study

Ibrahim Mohamed Ali Ibrahim Abd Elrahman1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
10
试验地点
1
主要终点
retention

研究概览

简要总结

The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.

详细描述

completely edentulous male patients will be selected from the out patient clinic of Removable Prosthodontic Department, Faculty of Oral and Dental medicine Al-Azhar University (Boys), Cairo, Egypt. patients will be selected and divided into randomly two equal groups and each patient will receive two sets of complete dentures: Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed. Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval. Patient satisfaction will be measured for all patients after 1 and 3 months follow up through a validated questionnaire. Masticatory efficiency will be measured by measuring muscle activity of the masseter and anterior fibers of the temporalis muscle on both sides for both dentures at one week, one month and three months after delivery using electromyography with three types of test foods. Microbial adhesion Samples will be collected one month after delivery of dentures, swaps will be taken from the fitting palatal surface of the upper denture, this will be done immediately after removal of the denture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Completely edentulous male patients ranging from age 45 to 60 years.
  • •Angle's Class I skeletal relationship.
  • •Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
  • •Last extraction took place six months ago.
  • •Normal facial symmetry.
  • •Cooperative patients.

排除标准

  • •Temporomandibular disorders.
  • •Uncontrolled diabetes.
  • •Flabby tissues or sharp mandibular residual ridge.
  • •Patients with neuromuscular disorders.
  • •Patients on chemotherapy or radiotherapy.
  • •Severe psychiatric disorders.
  • •Angle's class II and III skeletal relationship

研究组 & 干预措施

GroupI

Other

First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin.

干预措施: polyamide and 3D printed complete denture (Other)

Group II

Other

First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed

干预措施: polyamide and 3D printed complete denture (Other)

结局指标

主要结局

retention

时间窗: 6 months

Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval.

次要结局

未报告次要终点

研究者

发起方
Ibrahim Mohamed Ali Ibrahim Abd Elrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ibrahim Mohamed Ali Ibrahim Abd Elrahman

prosthodontist

Al-Azhar University

研究点 (1)

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