Device for guided bone regeneration and production method

Abstract

The present invention relates to a device for guided bone regeneration, intended for the reconstruction of a buccal bone defect, composed of zirconium dioxide and having a shape which covers said buccal bone defect. The present invention also relates to a method for producing a device of the invention, comprising a step of constructing the device of the invention according to a three-dimensional representation obtained by means of a technique of maxillo-dental imaging of the bone defect.

Claims

1. A device for guided bone regeneration for reconstruction of an oral bone defect, comprising: a body composed of zirconium dioxide and having a shape configured to cover said oral bone defect and to create a volume between the body and the oral bone defect; and a window arranged at an aperture in a wall of the body configured for insertion and condensation of a biomaterial through the window into the volume; wherein the window comprises an open position in which the aperture is exposed to allow for the insertion of the biomaterial through the aperture into the volume, and a closed position in which the aperture is occluded to contain the biomaterial in the volume and to allow for the condensation.

2. The device as claimed in claim 1, wherein the body comprises at least one other constituent selected from yttrium oxide, hafnium oxide and aluminum oxide.

3. The device as claimed in one of claim 1, wherein the shape of the body is selected from a shell, a plate and a net.

4. The device as claimed in claim 1, wherein the body comprises at least one perforation for stabilizing said device, said perforation being intended to receive an osteosynthesis screw.

5. The device as claimed in claim 1, wherein the wall has a thickness comprised between 0.6 mm and 1.8 mm.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 depicts a bone volumetric reconstruction schematized in three dimensions. A: face-on view of the volume to be reconstructed. B: view from above of the volume that is to be reconstructed. C: view from below of the volume that is to be reconstructed.

(2) FIG. 2 depicts a view of the bone volume to be reconstructed, after cleaning and definition of the fill volume through a mirroring effect. A: face-on view of the volume to be reconstructed. B: view from above of the volume to be reconstructed. C: view from beneath of the volume to be reconstructed.

(3) FIG. 3 depicts a view of a cup that is 0.8 mm thick with a 1 mm offset above the volume that is to be filled. A: face-on view of the volume that is to be reconstructed. B: view from above of the volume that is to be reconstructed. C: face-on view of the volume that is to be reconstructed.

(4) FIG. 4 depicts a view in cross section of a shell covering the bone volume that is to be reconstructed.

(5) FIG. 5 depicts a face-on view of a shell comprising a window measuring 6 mm tall by 5.5 mm wide, and two fixing holes each with a diameter of 1.4 mm.

EXAMPLES

Example 1: Preparation of a Device in the Form of a Shell Intended for Guided Bone Regeneration

(6) A model of the volume of the quantity of bone to be reconstructed is created using cone beam volumetric tomography.

(7) A 3D representation of the reconstruction of the bone defect is digitally schematized using the MIMICS/3-matic software package so as to quantify the bone substance to be regenerated.

(8) Using this pattern, an optional additional layer 1 mm thick is added to the 3D representation, then a shell 0.6 to 1.8 mm thick is designed so that it covers the 3D plan mentioned.

(9) Perforations are designed so as to stabilize the future zirconia shell using osteosynthesis screws.

(10) Once the shell pattern has been validated, the shell is printed in zirconia using a 3D printer.

Example 2: Example of Use of the Guided Bone Regeneration Device

(11) The patient was prescribed preoperative medication: clavulanic amoxicillin acid (2 g per day), and prednisolone (60 mg per day).

(12) Paracetamol/codeine and mouthwash (0.12 chlorexidine) were prescribed for after the operation.

(13) The procedure was carried out under local anesthetic Ubistesine? with 1:200000 vasoconstrictor.

(14) Decontamination with Betadine? was performed intra- and extra-orally. A supra-crestal and then intra-sulcular incision were made with a 15 C scalpel blade to end in two oral release incisions. A complete strip of tissue was lifted up, then the strip was released after the periosteal incisions. The strip was dissected using a pair of Metzenbaum? dissecting scissors.

(15) The customized zirconia shell/mesh was positioned. Holes were bored through the holes in the existing envelope. The two osteosynthesis screws were partially screwed in, then the allogenic biomaterials were placed under the cup. The screws were tightened to ensure the stability of the biomaterial. Sutures were applied, edge to edge, without tension.