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Completed

NCT Number: NCT03137914

Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculdade de Medicina de Petrópolis

Petrópolis, Rio de Janeiro, 25680120, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous chondrocyte transplantation

Biological

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

Orthognathic Surgery

Procedure

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

Primary outcomes

  1. Clinical improvement of the research participant after cell transplantation over 12 months

    Time frame: 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 outcomes

  1. Regeneration of articular cartilage after cellular transplantation

    Time frame: 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.

  2. Improvement of the researcher's quality of life after cell transplantation over 12 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

Other

Registry information

Official study title

Clinical Study for the Evaluation of the Safety and Effectiveness of Autologous Chondrocytes Transplantation for the Treatment of Condylar Resorption Associated With Dentofacial Deformities

Important dates

Study start
2015
Primary completion
2016
Study completion
2020
First posted
May 3, 2017
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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