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临床试验/NCT06831214
NCT06831214招募中不适用

Assessment of Bone Gain Following Composite Graft Rehabilitation of Horizontal Maxilla Atrophy With Sausage Technique Utilizing (Pericardial) Collagen Membrane Versus Periosteal Membrane Harvested From the Iliac Crest A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
22
试验地点
1
主要终点
Horizontal bone gain

研究概览

简要总结

This study designed to assess amount of bone gain following composite graft rehabilitation of horizontal maxilla atrophy with sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest in 6 months.

详细描述

Edentulous Maxillary ridges are a growing challenge worldwide. According to a fact sheet released by the World Health Organization (WHO) in 2022. teeth loss can be attributed to many conditions, mainly advanced dental caries, and severe periodontal disease. But pathology trauma and infection are other potential causes. Substantial studies have shown Dental implants as an excellent treatment choice with predictable long-term results.

However, to guarantee the success of implant stability at the time of insertion, a sufficient amount of bone width is robust. As known that bone surrounding extracted teeth resorb in all directions. This leads to horizontal and vertical bone volume loss reaching up to 50% in width reduction which compromises dental implant insertion. Cawood and Howell in 1988 categorized the degrees of edentulous ridge atrophy into six categories, emphasizing category IV atrophies which are known as "knife-edge" ridge, present a serious horizontal defect, making dental implant placement a challenge.

The challenge of bone defects augmentation primarily lies in the insufficient bone volume at the implant site, which can negatively impact the success of dental implants. Severe horizontal bone defects, such as those classified as "knife-edge" ridges, present significant obstacles for effective implant placement. Sausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing. Still some limitation of this technique including possibility of the collagen membrane becoming exposed during the healing process, which can compromise the regenerative outcome. Limited Bone Gain: In some cases, the amount of bone gain achieved may not meet the expectations, particularly in severely atrophic ridges, which can lead to the need for additional augmentation procedures. A study by Fernando V, et al showed that recipient sites augmented with autogenous bone grafts and preserved periosteal membranes maintained an average bucco-lingual width of 8.1 mm after augmentation, which was significantly greater than the baseline width of 3.2 mm. This augmented width was maintained at 98% after an average follow-up of 2.9 years. Another study by Kubota and Shirasuna evaluates the effectiveness of free periosteum in secondary bone grafting for maxillary alveolar clefts.

Results indicate that 97.1% of patients receiving free periosteum achieved significant vertical bone formation, compared to 79.5% in the control group. While the free-periosteum group experienced a higher rate of postoperative wound dehiscence. The rationale of the study is to evaluate the effectiveness of a combination of autogenous bone and an organic bovine bone-derived mineral (ABBM) for horizontal ridge augmentation using sausage technique utilizing (pericardial) collagen membrane versus Periosteal membrane harvested from the iliac crest. The study aimed to Assess bone gain in insufficient maxillary alveolar ridge width, particularly in patients with knife-edge ridges, to facilitate successful dental implant placement.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age range (18-60 years)
  • •Patients with unilateral or bilateral horizontal atrophy in maxilla with minimum 1 quadrant.
  • •No intervention done previously on the donor and host sides.
  • •No sex predilection

排除标准

  • •Syndromic patients.
  • •bone metabolism & systemic diseases.

研究组 & 干预措施

pericardial collagen membrane

Experimental

Sausage Technique: Specifically designed for cases with severely thin ridges, this technique utilizes a collagen membrane stabilized with titanium pins to secure the bone graft. This helps prevent the migration or collapse of graft particles, promoting better bone gain and healing

干预措施: (pericardial) collagen membrane (Other)

periosteal Membrane harvested from anterior iliac bone

Active Comparator

The choice of comparators in clinical studies involving guided bone regeneration (GBR) often includes both nonresorbable and resorbable membranes. Resorbable membranes have demonstrated better soft tissue compatibility compared to nonresorbable options, making them a preferred choice in many cases. For instance, studies have shown that using an organic bovine bone-derived mineral (ABBM) in conjunction with a rapidly resorbing natural collagen membrane is effective for horizontal ridge augmentation, as evidenced by positive histologic outcomes.

干预措施: periosteal Membrane harvested from anterior iliac bone (Other)

结局指标

主要结局

Horizontal bone gain

时间窗: 6 months

Bone caliper intra-operative and at time of implant placement CBCT, preoperative, immediate to assess amount of bone gain postoperative

次要结局

  • Percentage of newly formed bone(6 months)

研究者

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

Manaf Omar Alhabshi

Principal investigator

Cairo University

研究点 (1)

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