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临床试验/NCT06139003
NCT06139003已完成不适用

Evaluation of Digital Versus Conventional Techniques for Construction of Mandibular Implant Retained Overdenture

Mansoura University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月20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
20
试验地点
1
主要终点
occlusal stability

研究概览

简要总结

The aim of this study is to evaluate of two different construction techniques (digital and conventional techniques) for two implant retained complete mandibular overdenture regarding:

1. Digital occlusion stability detection: evaluated by using OccluSense.

Evaluation was done in the following evaluation period:

T0: Immediately after over denture insertion. T6: 6 months after over denture insertion. T12: 12 months after over denture insertion.

详细描述

Patient selection and study design:

Six patients who required complete denture were selected from the diagnostic clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University. All patients were informed about the procedures that was done and a written consent form of ethical committee. All patients had the right to withdraw from the study at any time.

Patients Grouping:

Patients were divided in to 2 equal groups:

Group (I): 3 patients received maxillary CD and mandibular 2-implant retained overdenture constructed by digital technique.

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 (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

  • •healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis.
  • •Completely edentulous jaws for at least 1 year.
  • •The angle's class I maxillomandibular relationship and have upper and lower completely edentulous arches.
  • •Residual alveolar ridges covered with healthy firm mucosa.
  • •All included patients' sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone).

排除标准

  • •Patients with systemic diseases that contraindicate implant placement such as hematologic diseases
  • •metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
  • •History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
  • •History of radiation therapy in the head and neck region.

研究组 & 干预措施

3d Printed implant overdenture

Experimental

patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by digital technique.

干预措施: 3d Printed implant (Device)

Conventionally constructed implant overdenture

Experimental

patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by conventional technique.

干预措施: Conventionally constructed implant (Device)

结局指标

主要结局

occlusal stability

时间窗: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Using occlusense device to determine distribution of occlusal forces over anterior and posterior areas, right and left side through chart representing areas of occlusal contact

Occlusal analysis

时间窗: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Group I and group II will be subjected to test by utilization of the Digital Occlusal Analyzer System (OccluSense) then amount of occlusal force over each unit presented in percentage

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

Mohamed shady

principle investigator

Mansoura University

研究点 (1)

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