Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-08

Study Completion Date

2020-12-02

Brief Summary

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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.

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Detailed Description

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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

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous chondrocyte transplantation

Intervention Type BIOLOGICAL

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

orthognathic surgery

Intervention Type PROCEDURE

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

Interventions

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Autologous chondrocyte transplantation

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

Intervention Type BIOLOGICAL

orthognathic surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No