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临床试验/NCT04022538
NCT04022538Unknown不适用

Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Final Vertical Alveolar ridge height

研究概览

简要总结

Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.

详细描述

Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates.

Description of Sandwich Osteotomy procedure to be done:

  • A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa.
  • The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing.
  • With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues.
  • The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone.
  • The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 20-55 years. No sex predilection.
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
  • Normal vertical dimension with increased inter-arch space.
  • The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.

排除标准

  • • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
  • Previous grafting procedures in the edentulous area.
  • Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.

研究组 & 干预措施

Sandwich osteotomy with simultaneous implant placement

Experimental

This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft.

干预措施: Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement (Procedure)

Sandwich osteotomy using micro-plates fixation

Active Comparator

This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft.

干预措施: Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation (Procedure)

结局指标

主要结局

Final Vertical Alveolar ridge height

时间窗: 4 months postoperatively

Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography

次要结局

  • Patient Satisfaction: scale from 1 to 10(4 months postoperatively)

研究者

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

Mohammed Ahmed Ali Abdulkhaleq Al-dubai

Master Candidate of Oral & Maxillofacial Surgery, Faculty of Oral & Dental Medicine

Cairo University

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