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Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

NCT03137914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-02-23

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Disorders

Interventions

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

Sponsors & Collaborators

  • Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

    lead OTHER

Principal Investigators

  • Radovan Borojevic · Faculty of Medicine of Petrópolis

  • Paulo Guimarães · Faculty of Medicine of Petrópolis

  • Ricardo Tesch · Faculty of Medicine of Petrópolis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-08
Primary Completion
2016-05-08
Completion
2020-12-02

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137914 on ClinicalTrials.gov