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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous chondrocyte transplantation | Experimental | Autologous transplant of chondrocytes diluted in hyaluronic acid after orthognathic surgery. The transplantation will be performed through an intra-articular injection into the TMJ (arthrocentesis). Hyaluronic acid is used only as a soluble medium to dilute the chondrocytes, so it is not considered as another experimental group, or as part of interest in this investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous chondrocyte transplantation | Biological | intraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement of the research participant after cell transplantation over 12 months | The function of the temporomadibular joint will be evaluated through the system used for the diagnostic classification "Research Diagnostic Criteria for Temporomandibular Disorders" (RDC/TMD). | The clinical evaluations will be performed 7 and 15 days and 1, 3, 6 and 12 months after a treatment application |
| Measure | Description | Time Frame |
|---|---|---|
| Regeneration of articular cartilage after cellular transplantation | The participant will be submitted to the image examination (computed tomography) for evaluation of the articular osteochondral tissue. | The imaging tests (by computed tomography) will be performed 6 and 12 months after the cellular transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radovan Borojevic | Faculty of Medicine of Petrópolis | Study Chair |
| Paulo Guimarães | Faculty of Medicine of Petrópolis | Study Director |
| Ricardo Tesch | Faculty of Medicine of Petrópolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina de Petrópolis | Petrópolis | Rio de Janeiro | 25680120 | Brazil |
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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.
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| orthognathic surgery | Procedure | Orthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation |
|
| Improvement of the researcher's quality of life after cell transplantation over 12 months |
The participants will be evaluated according to the questionnaire "Research Diagnostic Criteria for Temporomandibular Disorders" (RDC/TMD) to evaluate satisfaction with experimental treatment. |
| The questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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