Clinical Trial: Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Study for the Evaluation of the Safety and Effectiveness of Autologous Chondrocytes Transplantation for the Treatment of Condylar Resorption Associated With Dentofacial

Brief Summary: This clinical study has as main objective to evaluate if the Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption is safe and effective in the treatment of degenerative lesions of temporomandibular joint (TMJ). It is a case series, in which 10 participants with diagnosis of condylar reabsorption of TMJ will be selected, with orthognathic surgery indicated. Orthognathic surgery is conventionally indicated for patients with condylar resorption to correct dentofacial deformity and, therefore, will not be performed only in function of this clinical study. The selected participants will be submitted to nasal cartilage biopsy, for isolation and preparation of the chondrocytes. The only experimental group to be evaluated will be the group treated with autologous chondrocytes diluted in hyaluronic acid. The experimental treatment will be performed 15 days after orthognathic surgery, and will be injected through arthrocentesis. Clinical follow- up will be performed in the following periods: 7 and 15 days and 1, 3, 6 and 12 months after treatment. During the consultations, participants will also be evaluated for the intensity and severity of the pain experienced, as well as the disability related to it, through the same system used for the diagnostic classification (RDC / TMD). Imaging of the TMJ will be performed before, 6 and 12 months after the injection of the experimental treatment for bone and cartilaginous joint tissue analysis. Autologous chondrocyte implantation is expected to promote the regeneration of TMJ cartilage tissue safely and effectively.

Detailed Summary: The only experimental group to be evaluated will be the group treated with autologous chondrocytes diluted in hyaluronic acid, to be included in groups of 2, 4 and 4 participants. Only two participants will initially be included. If these two treated participants do not present adverse effects in 3 months, we will start a second stage with 4 participants. Again we will analyze the group over 3 months and if there are no problems we will include the 4 final participants, totaling the 10 participants.
Sponsor: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

Current Primary Outcome: Change in participant's clinical status after cell transplantation over 12 months [ Time Frame: The clinical evaluations will be performed 7 and 15 days and 1, 3, 6 and 12 months after a treatment application ]

The participant will be evaluated clinically to verify the intensity and severity of pain as well as the functional incapacity of the temporomandibular joint, through the system used for the diagnostic classification "Research Diagnostic Criteria for Temporomandibular Disorders" (RDC/TMD).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Regeneration of articular cartilage after cellular transplantation [ Time Frame: The imaging tests (by computed tomography) will be performed 6 and 12 months after the cellular transplantation ]
    The participant will be submitted to the image examination (computed tomography) for evaluation of the articular osteochondral tissue. The researchers will evaluate: 1) Degree of filling of the defect based on the thickness of the repair tissue and 2) Degree of integration of the repair tissue with adjacent cartilage.
  • Change in participant's quality of life after cell transplantation over 12 months [ Time Frame: The questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months ]
    The participants will be evaluated according to the questionnaire "Research Diagnostic Criteria for Temporomandibular Disorders" (RDC/TMD) to evaluate improvement of pain, mobility, degree of independence and satisfaction with experimental treatment.


Original Secondary Outcome: Same as current

Information By: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

Dates:
Date Received: April 25, 2017
Date Started: May 8, 2015
Date Completion: January 2, 2020
Last Updated: April 28, 2017
Last Verified: April 2017