Customized CAD/CAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects: Preliminary Results of a Prospective Clinical Follow-up Study in Humans
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
研究概览
简要总结
The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view
详细描述
Objectives:
-
to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body and/or ramus mixed with bovine bone mineral bone granules (500-1000microns in diameter):
-
complication rate of the reconstructive procedure;
-
assessment of bone gain obtained before implant placement;
-
implant survival and implant-related complications 1 year after the starting of prosthetic loading;
-
peri-implant bone resorption (MBL) after 1 year from the prosthetic load.
-
to perform a histomorphometric analysis of bone samples taken from sites reconstructed according to the principle of Guided Bone regeneration by means of autologous bone chips mixed with a xenograft with a 1:1 ratio and customized titanium mesh.
The following parameters will be analyzed from an histologic point of view:
- bone remodeling and mineralization levels of the new bone matrix
- volumetric tissue fractions
- neo-vascularization
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy patients;
- •a minimum age of 18 years;
- •relevant or severe bone atrophy at the edentulous sites incompatible with placement of even short (≤6 mm) or narrow (<3 mm) implants in an appropriate and prosthetically guided position;
- •adequate compliance of patients, both in terms of oral hygiene and respect the follow-up recalls;
- •ability to understand the proposed surgical treatment and to understand and sign the informed consent.
排除标准
- •severe kidney and/or liver disease;
- •congenital or acquired immunodeficiency;
- •ongoing antiblastic chemotherapy at the time of first examination;
- •sequelae of radiotherapy in the head and neck area;
- •oral mucosa diseases, such as lichen planus;
- •full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) < 20%;
- •non-compliant patients;
- •tobacco abuse (>10 cigarettes per day) or alcohol abuse;
- •non compensated diabetes;
- •active periodontal disease at the time of first examination ;
- •bisphosphonate chemotherapy in progress;
- •pregnant women.
结局指标
主要结局
Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
时间窗: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications
时间窗: 12 months
Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed
Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions
时间窗: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption
时间窗: 6-9 months
Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed
Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization
时间窗: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure
时间窗: 6-9 months
Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain
时间窗: 6-9 months
Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival
时间窗: 12 months
Implant survival (expressed in percentage) will be analyzed
次要结局
未报告次要终点
研究者
Prof. Matto Chiapasco
Professor
University of Milan