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临床试验/NCT06376019
NCT06376019已完成不适用

Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

Ain Shams University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年4月25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
39
试验地点
1
主要终点
Assessment of occlusion/disocclusion time

研究概览

简要总结

complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

详细描述

The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

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

盲法说明

the statistician will be the only one to be blinded

入排标准

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

入选标准

  • •completely edentulous patients
  • •non-smokers
  • •good oral hygiene
  • •motivated patients

排除标准

  • •major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
  • •the need for extensive bone grafting in planned implant site
  • •pregnancy
  • •patients under bisphosphonate treatment
  • •limited mouth-opening for executing the implant surgery.

研究组 & 干预措施

group CD (conventional complete denture group)

Placebo Comparator

patients will receive a conventional complete denture with no implant placement

干预措施: complete denture (Procedure)

group IB (implant-supported overdenture with ball attachment)

Active Comparator

patients will receive an implant-supported overdenture with ball attachment. The overdenture will be relined by a soft liner.

干预措施: solitary Implant loading with ball attachment (Procedure)

group II (implant-supported overdenture with an intraoral welded bar)

Active Comparator

patients will receive an implant-supported overdenture with an intraoral welded bar. The overdenture will be relined by a soft liner.

干预措施: splinted Implant loading with intra oral welding (Procedure)

结局指标

主要结局

Assessment of occlusion/disocclusion time

时间窗: 3 months

occlusion/disocclusion time will be evaluated using a T scan device

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

Ahmed Mostafa Abdelfatah

associate professor of oral and maxillofacial prosthodontics

Ain Shams University

研究点 (1)

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