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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Milan
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
Study Overview
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 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
edentulous patients with atrophic jaws
patients presenting with severely atrophic edentulous sites in the upper and lower jaw, and requesting implant-supported prosthetic restorations, will be enrolled in this study.
Intervention: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges (Procedure)
Outcomes
Primary Outcomes
Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
Implant survival (expressed in percentage) will be analyzed
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Matto Chiapasco
Professor
University of Milan