Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480073
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-07-04
Brief Title:
Guided Bone Regeneration With Customized Titanium Meshes
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Customized CADCAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects Preliminary Results of a Prospective Clinical Follow-up Study in Humans
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Objectives
to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body andor 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 11 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
Study method prospective study - 24 consecutive patients treated see statistical power analysis
The study will be performed in accordance with the ISO Standard 14155 2011 Clinical Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the Medical Device Directive 9342 EEC and following the 2004 Helsinki Declaration
The null hypothesis H0 is the following the reconstructed bone is not functionally mature to support implants masticatory and functional loads after 12 months
The sample size calculation was performed with the statistical program httpsclincalccomstatssamplesizeaspx A literature search on PubMed was performed and revealed that on average the percentage of new bone formed after reconstructions with particulate bone autografts and xenografts and titanium mesh is 66 with a standard deviation of 6 The expected percentage value for the investigators study was set at 70 with a statistical power of 90 and a two-tier significance level of 005
Data distribution will be analyzed by Shapiro Wilks normality test due to the small sample size
If the data distribution is normal the comparative analysis for the primary outcome will be performed by T-student test for paired samples If the data distribution is not normal a Wilcoxon test will be performed
The independent variable of the study is the bone reconstruction procedure The dependent variables are a the histomorphometric values of the reconstructed bone b the increase measured in mm of the bone reconstruction obtained c the MBL in mm peri-implant 1 year after the prosthetic load
Data analysis will be performed with SPSS software Differences will be considered statistically significant for alpha 005
to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body andor 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 11 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
Study method prospective study - 24 consecutive patients treated see statistical power analysis
The study will be performed in accordance with the ISO Standard 14155 2011 Clinical Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the Medical Device Directive 9342 EEC and following the 2004 Helsinki Declaration
The null hypothesis H0 is the following the reconstructed bone is not functionally mature to support implants masticatory and functional loads after 12 months
The sample size calculation was performed with the statistical program httpsclincalccomstatssamplesizeaspx A literature search on PubMed was performed and revealed that on average the percentage of new bone formed after reconstructions with particulate bone autografts and xenografts and titanium mesh is 66 with a standard deviation of 6 The expected percentage value for the investigators study was set at 70 with a statistical power of 90 and a two-tier significance level of 005
Data distribution will be analyzed by Shapiro Wilks normality test due to the small sample size
If the data distribution is normal the comparative analysis for the primary outcome will be performed by T-student test for paired samples If the data distribution is not normal a Wilcoxon test will be performed
The independent variable of the study is the bone reconstruction procedure The dependent variables are a the histomorphometric values of the reconstructed bone b the increase measured in mm of the bone reconstruction obtained c the MBL in mm peri-implant 1 year after the prosthetic load
Data analysis will be performed with SPSS software Differences will be considered statistically significant for alpha 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None