跳至主要内容
临床试验/NCT03989193
NCT03989193Unknown不适用

Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting With Simultaneous Implant Placement Versus Conventional Technique (a Randomized Clinical Trial)

Cairo University0 个研究点目标入组 12 人开始时间: 2019年11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
12
主要终点
the amount of marginal bone loss

研究概览

简要总结

This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply.

详细描述

All the procedures will perform under local anesthesia (mepivacain with levonordefrin). Horizontal Atrophic maxillary sectors will use for the development of the treatment sequence. All the patients will prepare initially with study models that permitted surgical and prosthetic planning as well as the non-strict surgical guide for intraoperative use. After application of conventional local anesthesia techniques, a full thickness incision 3 line pyramidal flap will be expose the defect ridge. The incision will extend to the next tooth or at least 5 mm more posterior from the end of the osteotomy indicated, securing direct observation of the alveolar crest.

With a direct view of the alveolar crest, if the ridge presented a width close to 1.5 mm, the ARST was performed immediately; if it presented less than 1.5 mm, then it was worn down with a diamond bur (low speed motor at 1800 rpm) to reduce the height, obtaining an improved alveolar crest width up to approximately 1.5 mm.

With this condition the bone splitting technique could be performed using the piezoelectric system (Piezotome2¨, Satelec Action, France), calibrating the device on the D1 setting and using profuse saline irrigation. The preparation sequence was begun with the CS3 insert until a total depth of 10 mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The CS% insert was used in two patients with the possibility of widening the osteotomy segment; this sequence always achieved a complete extension in depth of application.

In the study group the vertical bone cuts through the cortical layer.

  • At the distal end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm. Final design of the splitting cut was (L-SHAPE) SPLIT The control group the vertical bone cuts through the cortical layer.
  • At the distal and mesial end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm corresponding and joining the previous vertical cut.

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
18 Years 至 58 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency).
  • •Patients with free medical history and adequate proper oral hygiene.
  • •Patients of adequate alveolar bone height.
  • •Both genders males and females will be included.

排除标准

  • •General contraindications to implant surgery.
  • •Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • •Untreated periodontitis.
  • •Poor oral hygiene and motivation.
  • •Uncontrolled diabetes.
  • •Pregnant or nursing.
  • •Substance abuse.
  • •Psychiatric problems or unrealistic expectations.
  • •Severe bruxism or clenching.
  • •Immunosuppressed or immunocompromised.
  • •Treated or under treatment with intravenous amino-bisphosphonates.
  • •Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
  • •Active infection or severe inflammation in the area intended for implant placement.
  • •Need of bone augmentation procedures at implant placement.
  • •Unable to open mouth sufficiently to accommodate the surgical tooling.
  • •any 'complex case' if implants had to be placed in the aesthetic zone defined as second to second maxillary premolars.
  • •Patients participating in other studies, if the present protocol could not be properly followed.
  • •Requiring only single implant-supported crowns.

研究组 & 干预措施

Computer guided alveolar ridge splitting technique

Experimental

Computer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed.

干预措施: Computer guided alveolar ridge splitting technique (Device)

结局指标

主要结局

the amount of marginal bone loss

时间窗: 6 months

the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).

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

Basel mohammed hamzah

principal investigator

Cairo University

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