Trial record 4 of 107 for:    Open Studies | "Jaw"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Instituto Mexicano del Seguro Social
Sponsor:
Collaborator:
Hospital Civil de Guadalajara Fray Antonio Alcalde
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT02081885
First received: January 31, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Mandibular Fractures
Procedure: Tricalcium Phosphate / Chitosan
Procedure: Autologous Graft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Tricalcium Phosphate and Chitosan as Bone Regenerator Versus Autologous Graft in Surgery for Mandibular Fracture

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • Bone density determination in regenerated bone. [ Time Frame: 30 days after the procedure. ] [ Designated as safety issue: Yes ]
    Determined with computed tomography measure by using Hounsfield Units.

  • Bone density determination in regenerated bone. [ Time Frame: 6 months after the procedure. ] [ Designated as safety issue: Yes ]
    Determined with computed tomography measure by using Hounsfield Units.


Secondary Outcome Measures:
  • Classification of mandibular fracture [ Time Frame: One day before surgery ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Identifying the different possible infectious postoperative complications.

  • Defect Size [ Time Frame: 30 days after the procedure. ] [ Designated as safety issue: Yes ]
    According to the millimeters of bone structures missed.

  • Edema [ Time Frame: 8 days after procedure. ] [ Designated as safety issue: Yes ]
    Identifying the presence or absence of edema.

  • Edema [ Time Frame: 30 days after procedure. ] [ Designated as safety issue: Yes ]
    Identifying the presence or absence of edema.

  • Edema [ Time Frame: 6 months after procedure. ] [ Designated as safety issue: Yes ]
    Identifying the presence or absence of edema.

  • Postoperative infection. [ Time Frame: 8 days after procedure. ] [ Designated as safety issue: Yes ]
    Identifying the different possible infectious postoperative complications.

  • Postoperative infection. [ Time Frame: 30 days after procedure. ] [ Designated as safety issue: Yes ]
    Identifying the different possible infectious postoperative complications.

  • Postoperative infection. [ Time Frame: 6 months after procedure ] [ Designated as safety issue: Yes ]
    Identifying the different possible infectious postoperative complications.

  • Defect Size [ Time Frame: 6 months after the procedure. ] [ Designated as safety issue: Yes ]
    According to the millimeters of bone structures missed.


Other Outcome Measures:
  • Age [ Time Frame: One day before surgery ] [ Designated as safety issue: Yes ]
    Completed years

  • Gender [ Time Frame: One day before surgery ] [ Designated as safety issue: Yes ]
    Male or Female


Estimated Enrollment: 24
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tricalcium Phosphate / Chitosan Procedure: Tricalcium Phosphate / Chitosan
Active Comparator: Autologous Graft Procedure: Autologous Graft

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ot the service of reconstructive and plastic surgery of the Civil Hospital in Guadalajara Fray Antonio Mayor, with a diagnosis of traumatic mandibular fracture with bone defect < 2.5 cm.
  • Wishing to participate in the study

Exclusion Criteria:

  • Patients who have undergone radiation therapy.
  • Psychiatric Patients.
  • Patients who have not signed informed consent.
  • Patients with Diabetes
  • Patients with alterations in bone metabolism
  • Patients with kidney diseases
  • Patients who receipt corticosteroids
  • Patients with heart disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081885

Contacts
Contact: Alejandro Gonzalez-Ojeda, PhD 523336189538 avygail5@gmail.com

Locations
Mexico
Civil Hospital of Guadalajara Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Alejandro Gonzalez-Ojeda, PhD    523336189538    avygail5@yahoo.com.mx   
Principal Investigator: Alejandro Gonzalez-Ojeda, PhD         
Sub-Investigator: Leonel Garcia-Benavides, PhD         
Sub-Investigator: Francisco J De La Peña-Brambila, MD         
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Hospital Civil de Guadalajara Fray Antonio Alcalde
Investigators
Principal Investigator: Alejandro Gonzalez-Ojeda, PhD Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: Alejandro Gonzalez-Ojeda, PhD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02081885     History of Changes
Other Study ID Numbers: Chitosan-2014-1
Study First Received: January 31, 2014
Last Updated: March 5, 2014
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Mexicano del Seguro Social:
Tricalcium phosphate
Chitosan
Grafting, Bone
Mandibular Fractures

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Fractures, Bone
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Skull Fractures
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on July 31, 2014