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临床试验/CTRI/2021/04/033054
CTRI/2021/04/033054尚未招募2 期

A Comparative Computerized Occlusal Analysis of ConventionalComplete Denture and Single Implant Supported Mandibular Overdenture

CDER1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年1月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
CDER
入组人数
18
试验地点
1
主要终点
1.To evaluate number of occlusal tooth contacts (tooth contact from canine to second molar area) in centric occlusion in single implant retained mandibular overdenture and conventional complete denture patient using computerized occlusal analysis system after 48hr, 3month and 6month of insertion of denture.

研究概览

简要总结

Therehas beenno study comparing thechanges in maximum occlusal force and changes in the distribution of occlusal contactafter use of conventional complete denture and single implant-supportedoverdenture.Hence this study has been designed. The null hypothesisstates that there will be statistically no significant difference in the numberof tooth contacts, percent bite force distribution, and percent bilateral force the difference in centric occlusion in cases with single implant-retainedmandibular overdenture or  conventionalcomplete  denture using computerizedocclusal  analysis system after 48hr,3month and 6month of insertion of the denture.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
50.00 Year(s) 至 74.00 Year(s)(—)
性别
All

入选标准

  • â— Patients should be completely edentulous for at least six months, first-time denture wearer, and of age group between 50-74 years.
  • â— Patient having a minimum of 10mm bone length and width of 4.5mm in the mandibular symphyseal region.
  • â— The patient having an Angle class 1 jaw relationship.
  • â— Patients who give a positive written informed consent.

排除标准

  • 1.Any history of metabolic or systemic disease affecting the integration of implant or connective tissue health surrounding implant.
  • 2.Any logistic or physical reason that could affect follow-up.
  • 3.History of radiation therapy to head and neck.
  • 4.History of drug or alcohol abuse.
  • 5.Heavy smokers.
  • 6.Unrealistic expectations.
  • 7.Insufficient primary stability of implant.
  • 8.History of temporomandibular disorders.

结局指标

主要结局

1.To evaluate number of occlusal tooth contacts (tooth contact from canine to second molar area) in centric occlusion in single implant retained mandibular overdenture and conventional complete denture patient using computerized occlusal analysis system after 48hr, 3month and 6month of insertion of denture.

时间窗: 48hr, 3 month and 6 month

2 To evaluate percent maximum occlusal force

时间窗: 48hr, 3 month and 6 month

次要结局

  • 1.To evaluate bilateral force difference (% difference between left chewing area and right chewing area from canine to second molar area)(2. To compare the number of occlusal tooth contacts, percent maximum occlusal force and bilateral force difference)

研究者

发起方
CDER
申办方类型
Research institution and hospital

研究点 (1)

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