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临床试验/NCT04254848
NCT04254848已完成不适用

Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori

Segi University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
changes in the oral stereognosis

研究概览

简要总结

This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.

详细描述

Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.

Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.

研究设计

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

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complete edentulous patient with maxillary tori and without maxillary tori
  • Complete edentulous patient who were willing give consent and eager to participate

排除标准

  • Patients with swallow and mastication dysfunction
  • Patients with cognitive disturbances
  • Uncooperative patients.
  • Patients with oral lesions, pathologies and Tempromandibular Joint disorders.
  • Patients with systemic diseases
  • Patients allergic to acrylic resin

结局指标

主要结局

changes in the oral stereognosis

时间窗: through study completion, an average of 1 year

Oral stereognosis test will be performed using test pieces will be placed intraorally and patients will be instructed to identify the shape of test pieces with their tongue and palate. A visual representation chart of all 6 shaped forms will be provided to patient for identification purpose. Patients will be asked to identify the correct shape form by pointing out on the corresponding shape form on the chart. The 6 test pieces will be presented randomly to the patients and correct answer will not be informed to the patients during the OSA. The duration time for recognition of each shaped form for each patient will be noted and answers will be recorded on an OSA evaluation form. A correct answer will recorded as one point and incorrect answer is zero point. A full 6 points will be scored if all answers were correct. The response time and the OSA scores will be recorded.

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

Indumathi Sivakumar

Research Supervisor and Principal investigator

Segi University

研究点 (2)

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