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临床试验/NCT06017791
NCT06017791已完成不适用

Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series

Cairo University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年11月8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
10
试验地点
1
主要终点
Gingival display

研究概览

简要总结

The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior maxilla placed by tunnel technique in decreasing the gingival display

详细描述

While lip repositioning has been established as a treatment modality to address excess gum display (EGD) , an often overlooked contributing factor is the lack of lip support. This is often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth may give rise to a subnasal skeletal depression producing decreased lip support and marked upper lip retraction during a smile.

Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle movement, however it does not address lip support. In 2018 an alternative intervention was later proposed in a case report study . The technique involves raising a full thickness flap and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit the upper lip movement. Since its introduction, a limited number of studies have attempted to investigate the technique, however there are not enough studies to support the outcome or the stability of the technique. The aim of the current study is to evaluate the use of a tunnel technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal depression

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with excess gingival display 2.5mm or more
  • Patients with an exaggerated subnasal concavity
  • Decreased/normal value of SNA ( angle between sella, nation, A point) in cephalometric measurement
  • Decreased/normal cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP)
  • Decreased/normal value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane)
  • Decreased/normal value of Ricketts Esthetic plane in cephalometric measurement
  • Decreased/normal value of Holdaway H-angle in cephalometric measurement
  • Nasolabial angle range from 100° to 120°
  • Patients 20-60 years old
  • Medically free
  • Compliant patient that agrees to the follow up period

排除标准

  • Pregnant and lactating females
  • Diabetics
  • Patients with parafunctional habits that may affect the outcome of the procedure
  • Medically compromised patients

结局指标

主要结局

Gingival display

时间窗: Day 0 - Month 3 - Month 6

measured using a periodontal probe in millimeters

次要结局

  • Post operative pain(Day 7)
  • profile angle(Day 0 - Month 6)
  • lip translation(Day 0 - Month 3 - Month 6)
  • blinded esthetic assessment(Month 3- Month 6)
  • patient satisfaction(Day 7)
  • lip length(Day 0 - Month 3 - Month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farah Mamdouh Abdelfatah Mohamed Sheeba

Principal investigator

Cairo University

研究点 (1)

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