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临床试验/NCT03391258
NCT03391258已完成不适用

Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - A Pilot Clinical Trial

Implantology Institute2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015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
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Changes in Regenerated Bone Gain (mm)

研究概览

简要总结

16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique.

Informed consents and local ethical committee clearance will be obtained. Pre, post and 12 months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine canal to the center of each implant will be determined (4 different locations per patient, corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs. Implant length will be measured, from the neck (site 1) to the top and then a middle point will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%), defined as the percentage of regenerated bone at 12 months, will be calculated as the comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be presented as mean, with 95% CI.

详细描述

Patients with maxillary atrophy and loss of lip support are often a challenge in terms of prosthodontic rehabilitation and surgical approach due to the aesthetic changes and bone availability for implant placement.

In edentulous patients, with severe maxillary atrophy and an obvious loss of lip support, the anterior maxilla commonly exhibits a thin buccal bone plate which requires horizontal bone augmentation, since various authors have mentioned that a minimum 2mm of facial bone is required to prevent vertical bone resorption.

The scientific literature describes several techniques for these cases (such as collagen or titanium membranes, non-resorbable pins, use of xenografts, allografts or autogenous bone) but still, none is considered as the gold standard.

The simultaneous approach, where implant placement is coincident with graft procedures, is preferred by both patients and clinicians, since it reduces treatment time and cost. However, it can't be applied in every case, due to the need of proper implant stability.

A significant clinical interest has grown regarding the use of L-PRF for regeneration, solely or in combination with xenografts, given its ease of protocol preparation, economic advantages, less invasive technique (no need for donor sites) and biological properties. Also, L-PRF has been used around immediately placed implants to restore the anatomy loss and to speed up soft tissue wound healing. However, the use of enough L-PRF membranes seems to be crucial to obtain an optimal effect.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18years of age, ASA I or ASA II patients

排除标准

  • ASA III or ASA IV patients; uncontrolled diabetes, immunosuppressant medication, heavy smokers or pre-surgical infectious area next to the surgical site

研究组 & 干预措施

Bone Regeneration with GLAM technique

Experimental

At the beginning of each surgery, a venipuncture will be performed, to obtain the L-PRF membranes. Also, two white topped tubes will be centrifuged for 3 minutes to obtain PRP. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area.

干预措施: Bone Regeneration with GLAM technique (Procedure)

结局指标

主要结局

Changes in Regenerated Bone Gain (mm)

时间窗: Pre-surgery, Baseline (0 days) and 12 month follow-up

Measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).

次要结局

  • Regenerated Bone Stability (%)(Baseline (0 days) and 12 month follow-up)
  • Post-Surgical Regenerated Bone Volume (mm)(Baseline (0 days))

研究者

发起方
Implantology Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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