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临床试验/NCT04679766
NCT04679766Unknown不适用

Evaluation of Ice Cream Cone Technique as a Flapless Guided Bone Regenerative Method With Immediate Implant Placement in Management of Patients With Labial Plate Dehiscence: A Case Series

Cairo University0 个研究点目标入组 10 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
主要终点
Changes in buccal/labial vertical bone dimensions

研究概览

简要总结

Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures ..

Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.

详细描述

Classical methods of guided bone regenerative methods succeeded to partially reconstitute the lost labial plate of bone using different grafting materials with barrier membranes.

This might be attributed to the necessity of using a full mucoperiosteal flap which interrupts the vascular supply to the bone and jeopardizing the process of total facial bone regenerative process. Therefore, Tan-Chu et al., (2014) described in a case report an innovative technique using resorbable collagen membrane in the shape of ice cream cone and allograft in the reconstitution of labial plate in patients with socket type II after extraction with folding the membrane to seal the socket and containing the blood clot to allow for occupation of osteogenic cell population without raising a flap. This technique showed an adequate bone regeneration with net result of 1.32 mm prior to no labial plate present before grafting. Hence, using immediate implant placement with the conjunction of the ice cream cone technique in regeneration of labial plate of bone needs to be further assessed to evaluate its clinical outcomes.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non-restorable teeth in maxillary inter-bicuspid region.
  • •All teeth have labial plate dehiscence (socket type II) after extraction.
  • •Patients free from any systemic conditions that may affect healing.
  • •Adequate bone volume for the placement of immediate implant.
  • •Presence of the adjacent teeth.
  • •Compliant patients.

排除标准

  • •Pregnant females.
  • •Patients who were taking or currently taking any of the bisphosphonates.
  • •Any disease that might affect bone metabolism as osteoporosis.
  • •Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.
  • •The presence of any signs of acute infection in the surgical site or the adjacent natural teeth.

研究组 & 干预措施

Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence

Experimental

干预措施: Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence (Procedure)

结局指标

主要结局

Changes in buccal/labial vertical bone dimensions

时间窗: 6 months post operative

Vertical bone dimension will be measured at day 0 and 6 months post-operative

次要结局

  • Keratinized tissue width(6 months)
  • Gingival thickness(6 months)
  • Changes in labial/buccal plate thickness(6 months)
  • Post operative pain measured with VAS scale(1 week -2 weeks)
  • Post-operative patient satisfaction with Yes or No question(6 months)

研究者

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

Mostafa Amagad

Principle investigator

Cairo University

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