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临床试验/NCT03887975
NCT03887975已完成不适用

T-Scan Evaluation for Different Types of Occlusion in Mandibular Overdenture Retained By Two Splinted Mini Implants (In Vivo Study)

Ain Shams University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年2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
14
试验地点
2
主要终点
traumatic dental occlusion by T-Scan III

研究概览

简要总结

Materials and methods: fourteen patients were selected according to the inclusion criteria, the participants were stratified equally into two groups, patients were assigned to receive either monoplane or lingualized occlusal schemes to their overdentures. For each patient placement of two mini-implants in the mandible at the canine region was done, bar joint attachment was used to splint the mini implants. Each implant was 2.5 mm in diameter and 10 mm in length. T-scan occlusal load analysis records were done in centric occlusion , the records was used to analyze the biting force of the denture as a Full Closure Force Movie recording, then Time vs. Force Graph of that Force Movie is accomplished. T-scan records were taken three times for each patient in the two groups ,Immediately after loading ,three months and six months of loading.

详细描述

Fourteen completely edentulous patients will be selected from the outpatient clinic of removable Prosthodontics Department, Faculty of Dentistry, Ain Shams University.

Patient's approval:

All participants were informed in details about the nature of the research and the purpose of the study. They should agree to take part in it and sign an informed consent form.

All reasonable measures to protect the security of the personal information and privacy of the patient protected health information will be taken.

All participants were given notice about their practices and their legal duties and rights.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Age range from 50-
  • Free from any systemic diseases affecting bone metabolism.
  • Free from tempromandibular joint disorders.
  • Having normal ridge relationship.
  • Adequate interarch space.
  • No parafunctional habits.
  • Residual ridge with adequate height covered by firm dense fibrous mucoperiosteum with no sharp spicules.

排除标准

  • systemic diseases affecting metabolism of bone e.g bone diseases, hyperparathyroidism and renal diseases
  • Severe blood disease (hemophilia ect)
  • Severe vascular heart disease
  • Liver problems
  • Severe immunodeficiency .Patients who are undergoing strong chemotherapy,Irradiated patients or requiring hard or soft tissue grafting of the proposed implant site.
  • Uncooperative patients who have no understanding of the need for regular follow-up .Patient diagnosed with neuromuscular disorders, para functional habits.

研究组 & 干预措施

Percentage of force in monoplane occlusion

Active Comparator

Different occlusal scheme evaluation using tscan

干预措施: Monoplane Occlusion (Procedure)

Percentage of force in lingualized occlusion

Active Comparator

Different occlusal scheme evaluation using tscan

干预措施: Lingualized occlusion (Procedure)

结局指标

主要结局

traumatic dental occlusion by T-Scan III

时间窗: 6months

To evaluate the stress distribution in mandibular overdenture retained by two splinted mini implants using monoplane and lingualized occlusion in setting of teeth using T-Scan.

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

Heba tarek abdallah

Principal investigator

Ain Shams University

研究点 (2)

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