Guided Bone Regeneration With Customized Titanium Meshes

NCT04480073 | Unknown

• 1 other identifier: MChiapasco
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Resorption

Keywords

guided bone regeneration; dental implants; alveolar bone defects; custom-made; Titanium mesh; CAD-CAM; implant-supported prosthesis; autogenous bone

Outcome Measures

Primary Outcomes (8)

• Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels

  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

  6-9 months

• Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions

  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

  6-9 months

• Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization

  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

  6-9 months

• Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure

  Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed

  6-9 months

• Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain

  Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed

  6-9 months

• Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival

  Implant survival (expressed in percentage) will be analyzed

  12 months

• Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications

  Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed

  12 months

• Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption

  Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed

  6-9 months

Study Arms (1)

edentulous patients with atrophic jaws

OTHER

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.

Procedure: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges

Interventions

Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges PROCEDURE

Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws. A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls. 6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement. Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement. 3 months later, implants will be uncovered and the prosthetic phases will start. Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications.

edentulous patients with atrophic jaws

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST Santi Paolo e Carlo

Milan, 20142, Italy

RECRUITING

Related Publications (3)

• Sagheb K, Schiegnitz E, Moergel M, Walter C, Al-Nawas B, Wagner W. Clinical outcome of alveolar ridge augmentation with individualized CAD-CAM-produced titanium mesh. Int J Implant Dent. 2017 Dec;3(1):36. doi: 10.1186/s40729-017-0097-z. Epub 2017 Jul 26.

  PMID: 28748521 RESULT

• Seiler M, Kammerer PW, Peetz M, Hartmann A. Customized lattice structure in reconstruction of three-dimensional alveolar defects. Int J Comput Dent. 2018;21(3):261-267.

  PMID: 30264055 RESULT

• Sumida T, Otawa N, Kamata YU, Kamakura S, Mtsushita T, Kitagaki H, Mori S, Sasaki K, Fujibayashi S, Takemoto M, Yamaguchi A, Sohmura T, Nakamura T, Mori Y. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh. J Craniomaxillofac Surg. 2015 Dec;43(10):2183-8. doi: 10.1016/j.jcms.2015.10.020. Epub 2015 Oct 23.

  PMID: 26603108 RESULT

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Matteo Chiapasco, Professor

  Department of Biomedical, Surgical and Dental Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Chiapasco, Professor

CONTACT

+390250319000; matteo.chiapasco@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 21, 2020
• Study Start: January 10, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)