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临床试验/NCT05475730
NCT05475730已完成不适用

Tunnel Access for Ridge Augmentation Using Xenogenous Bone, Hyaluronic Acid and Acellular Dermal Matrix

D'Albis Dental1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Augmented tissue volume

研究概览

简要总结

Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .

performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid.

Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments. Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly into the pocket and absorbable suture is used to close the vertical incision.

详细描述

Tunnel bone regeneration achieves treatment objectives using the least invasive surgical approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing postoperative pain and improving wound vascularization.

The present study value the clinical results of a subperiosteal minimally invasive ridge horizontal augmentation technique.

The technique includes the use of a laparoscopic approach to deliver hyaluronic acid,xenograft and a dermal matrix into a subperiosteal pouch.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
  • No general medical condition representing a contraindication to implant therapy
  • minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
  • No periodontal disease (periodontal probing depth <4 mm) or treated periodontitis
  • Good oral hygiene (full mouth plaque index<25%)
  • Adequate control of inflammation (full mouth bleeding on probing<25%)

排除标准

  • smoking of more than 15 cigarettes a day
  • untreated periodontal disease
  • pregnancy or breastfeeding at date of inclusion
  • acute infections
  • keratinized mucosal tissue less than 2 mm.

结局指标

主要结局

Augmented tissue volume

时间窗: 7 month

The edentulous ridge will be scanned with an intraoral scan 3 times. First time: Initial situation. Second time: 5 months after regeneration. Third time: After implant placement. Will be evaluate the 3 scan in a cad-cam software to evaluate the ridge three-dimensional changes.

次要结局

未报告次要终点

研究者

发起方
D'Albis Dental
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe D'Albis

Principal Investigator

D'Albis Dental

研究点 (1)

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