NCT03137914

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-08
• Primary completion: 2016-05-08
• Completion: 2020-12-02
• First posted: 2017-05-03
• Last updated: 2021-02-23

Locations

1 site across 1 country: Brazil