Trial | NCT03137914  Report issue

Title

Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery
Clinical Study for the Evaluation of the Safety and Effectiveness of Autologous Chondrocytes Transplantation for the Treatment of Condylar Resorption Associated With Dentofacial Deformities

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
Study Started
May 08
2015
Primary Completion
May 08
2016
Study Completion
Dec 02
2020
Last Update
Feb 23
2021

Biological Autologous chondrocyte transplantation

intraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid

Procedure orthognathic surgery

Orthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation

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.

Criteria 

Inclusion Criteria:

Clinical diagnosis of dentofacial deformities related to osteoarthritis of TMJ;
must have surgical indication.

Exclusion Criteria:

pregnant or breastfeeding;
infection or other comorbidities;
rheumatologic diseases;
chronic pain in another joint;
chronic use of corticosteroids and immunosuppressants.
No Results Posted