Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

Phase 1

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Biological: Autologous chondrocyte transplantation; Procedure: orthognathic surgery

• Registration Number: NCT03137914
• Lead Sponsor: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

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 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.

Study Timeline

• Study Start: 2015-05-08
• Primary Completion: 2016-05-08
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-03
• Study Completion: 2020-12-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

1. pregnant or breastfeeding;
2. infection or other comorbidities;
3. rheumatologic diseases;
4. chronic pain in another joint;
5. chronic use of corticosteroids and immunosuppressants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous chondrocyte transplantation	Autologous chondrocyte transplantation	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.
autologous chondrocyte transplantation	orthognathic surgery	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.

Primary Outcome Measures

Name	Time	Method
Clinical improvement of the research participant after cell transplantation over 12 months	The clinical evaluations will be performed 7 and 15 days and 1, 3, 6 and 12 months after a treatment application	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).

Secondary Outcome Measures

Name	Time	Method
Regeneration of articular cartilage after cellular transplantation	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.
Improvement of the researcher's quality of life after cell transplantation over 12 months	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 satisfaction with experimental treatment.

Trial Locations

Locations (1)

Faculdade de Medicina de Petrópolis; 🇧🇷 Petropolis, Rio De Janeiro, Brazil