Therapeutic Efficacy of Tricalcium Phosphate and Chitosan as Bone Regenerator Versus Autologous Graft in Surgery for Mandibular Fracture

Objective To evaluate the therapeutic efficacy of the combination of tricalcium phosphate and chitosan in comparison with autologous bone graft in bone regeneration applied to surgical mandibular fracture

Material and Methods Type of Study: Clinical Trial (Randomized) controlled This project will be performed in patients from the Service of Plastic and Reconstructive Surgery, Maxillofacial, Civil Hospital of Guadalajara Fray Antonio Alcalde diagnosed with facial fractures Computed tomography imaging study with axial and coronal skull, as well as three-dimensional reconstruction was performed, to obtain the size of the bone defect

Procedure A compound, with 5 grams of chitosan in an acidic solution, consisting of 2 ml acetic acid 99% water, is prepared. Leaving it under constant stirring for over 12 hours to obtain a chitosan acidic gel. The total volume of compound of chitosan will be doubly filtered to remove impurities and microorganisms that may contaminate the solution. The first filtration was carried out with Whatman paper No. 1 to remove residual impurities and the second whit nitrocellulose filter of 0.45 microns to ensure complete removal of bacteria and impurities. Once filtered, the chitosan compound be mixed with 0.2 g of tricalcium phosphate gauge and dispensed in 15-20ml in petri dishes and incubated at dry heat stove at 40 ° C for 16 hours or until completely evaporate the liquid phase, dehydration of the compound obtained in a thin film. The films of tricalcium phosphate and chitosan will be neutralized with 0.5% NaOH until evolution of the petri dish and then washed thoroughly with distilled water to remove traces of NaOH 0.5%. The film neutralized will be placed in a container for shape and incubated for 2 hours at 50 °C for drying. Subsequently, the films will be trimmed and sterilized in ultraviolet imager for 15 minutes and then sealed in packages of manufacturing list for your own use.

Description of the technical surgical To the patients selected for the protocol will be following the next described procedure; Under general inhaled anesthesia naso-tracheal via, we will proceed to clean with an adequate asepsis and antisepsis intraoral and face technique, sterile fields will be placed on a regular basis, and they will be infiltrate with lidocaine and epinephrine on the incision line depending on the type of approach. After this they will be incision in the skin and subcutaneous tissue, subsequently, with blunt dissection in deep planes, dissection of superficial cervical fascia and muscle platysma neck, until find the fracture traces in the jaw bone (depending on the classification on the anatomic localization). There will be a reduction of the fracture with manual traction, and placing a rigid bone fixation with plates and screws of titanium, and at the same time using cooling steril physiological solution to avoid overheating of the bone (at this moment the surgical process is identical in the two groups) after the end of this process and have a strong jaw, is then replaced the missing bone segment, the group with autologous graft from the iliac crest, where will be oblique incision with guidance bottom and back to the iliac crest, 1 cm from the back of the spine and approximate length of 5 cm, previous insertions of the abdominal muscles and external oblique Internal, until reach the periosteum.

The results package- lateral femoral cutaneous nerve and the lateral femoral cutaneous nerve are the only structures that must not be damaged during the dissection.