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临床试验/NCT05718050
NCT05718050已完成不适用

Mandibular Flexure: An In-vivo Study in Dentate Patients.

University of Rome Tor Vergata2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Mandibular Flexure in maximum opening (MO)

研究概览

简要总结

The flexion of the mandible (MF) is a multifactorial phenomenon that occurs simultaneously with mandibular movements determining changes in the shape of the mandible. mandibular flexure (MF) may cause complications and failures in both conventional and implant-supported fixed dental prostheses (FDP) especially when a long-span prosthesis is planned to connect the anterior to the posterior region of the mandible. Previous studies reported increased biomechanical stress at the prosthetic and implant level, poor passivity of fit, impression distortion, pain during function, de-cementation of the prosthesis, porcelain chipping, prosthetic screw loosening and fracture, bone resorption and implant fracture. The aim of this study is to quantify the dimensional changes related to MF by means of a cone beam computed tomography (CBCT) between maximum opening (MO) and maximum intercuspation (OVD) positions. The null hypothesis was that there is no significant difference in terms of length and width of the mandible between maximum intercuspation and maximum opening positions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Dentate patients,
  • 18 years of age or older,
  • Good health
  • Need of implant treatment

排除标准

  • active periodontitis with tooth mobility
  • neuromuscular disorders
  • temporomandibular joint disorders
  • parafunctional habits
  • systemic condition preventing surgery
  • history of oro-maxillofacial radiation therapy
  • history of drug or alcohol abuse
  • heavy smoking
  • uncontrolled diabetes
  • pregnancy
  • lactation.

结局指标

主要结局

Mandibular Flexure in maximum opening (MO)

时间窗: 24 hours

A blind assessor made 4 four measurements per patient on an implant planning software (DTX Studio Implant software, Dexis LLC), evaluating the distance between the fiducial landmark at the contralateral canines and contralateral molars, and between ipsilateral canines and molars on both sides

Mandibular Flexure in Occlusal Vertical Dimension (OVD)

时间窗: 24 hours

A blind assessor made 4 four measurements per patient on an implant planning software (DTX Studio Implant software, Dexis LLC), evaluating the distance between the fiducial landmark at the contralateral canines and contralateral molars, and between ipsilateral canines and molars on both sides

次要结局

未报告次要终点

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Carosi

Assistant Professor

University of Rome Tor Vergata

研究点 (2)

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