Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 1

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 description: 
      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.
    

Intervention name(s): Autologous chondrocyte transplantation; orthognathic surgery
Intervention type(s): Biological; Procedure
Intervention description(s): intraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid; Orthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment The clinical study model adopted is a single experimental group. Ten participants with dentofacial deformities related to severe degenerative TMJ changes, who are candidates for orthognathic surgery to repair these deformities, will be evaluated, who will be submitted to treatment with nasal septum autologous chondrocytes transplantation. There will be no evaluation of the control group in this study, as it is a case report. Injection of the experimental treatment will be done through an ultrasound-guided arthrocentesis.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: orthognathic surgery; TMJ; osteoarthritis