Clinical Trial: Tricalcium Phosphate and Chitosan as Bone Regenerator Versus Autologous Graft in Surgery for Mandibular Fracture

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

Introduction After a mandibular fracture where bone has been lost, a number of complications and challenges are presented in trying to solve them. These defects are mainly classified into two groups: functional and cosmetic. The functional defects are incompetence of the lower lip, salivary incontinence, severe difficulty chewing and swallowing, temporomandibular joint disorders and difficulty in pronouncing words.

Esthetically facial asymmetry is produced with collapse of the affected side. Unreconstructed jaw retrusion and tends to offset the affected side, there is a change in mandibular movements, which, previous vertical movements are replaced by oblique or diagonal movements controlled by a single temporomandibular joint. It also presents a limitation in motility and lingual force, besides proprioception disorder left by the inferior alveolar nerve The loss of bone in mandibular fractures, is one of the great challenges facing maxillofacial surgery and unfortunately increasingly common. That's why they have done and are still doing research for the development of biomaterials, all with the purpose of trying to solve this problem by offering the patient better results than those obtained in the past, restoring both function and facial aesthetics according to each case

Detailed Summary:

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 ultra
Sponsor: Instituto Mexicano del Seguro Social

Current Primary Outcome:

• Bone density determination in regenerated bone. [ Time Frame: 30 days after the procedure. ]
  Determined with computed tomography measure by using Hounsfield Units.
• Bone density determination in regenerated bone. [ Time Frame: 6 months after the procedure. ]
  Determined with computed tomography measure by using Hounsfield Units.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Classification of mandibular fracture [ Time Frame: One day before surgery ]
  They will be classified as Nasal, Maxilla-malar, Dentoalveolar, Mandibular and Lefort fracture.
• Edema [ Time Frame: Patients will be followed daily from the immediate postoperative period until discharge, an expected average of 3 days. ]
  Identifying the presence or absence of edema.
• Postoperative infection. [ Time Frame: Patients will be followed daily from the immediate postoperative period until discharge, an expected average of 3 days. ]
  Identifying the different possible infectious postoperative complications.
• Defect Size [ Time Frame: 30 days after the procedure. ]
  According to the millimeters of bone structures missed.
• Edema [ Time Frame: 8 days after procedure. ]
  Identifying the presence or absence of edema.
• Edema [ Time Frame: 30 days after procedure. ]
  Identifying the presence or absence of edema.
• Edema [ Time Frame: 6 months after procedure. ]
  Identifying the presence or absence of edema.
• Postoperative infection. [ Time Frame: 8 days after procedure. ]
  Identifying the different possible infectious postoperative complications.
• Postoperative infection. [ Time Frame: 30 days after procedure. ]
  Identifying the different possible infectious postoperative complications.
• Postoperative infection. [ Time Frame: 6 months after procedure ]
  Identifying the different possible infectious postoperative complications.
• Defect Size [ Time Frame: 6 months after the procedure. ]
  According to the millimeters of bone structures missed.

Original Secondary Outcome: Same as current

Information By: Instituto Mexicano del Seguro Social

Dates:
Date Received: January 31, 2014
Date Started: January 2014
Date Completion: January 2017
Last Updated: March 5, 2014
Last Verified: March 2014