Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

NCT03137914 | Completed Phase 1 DMC

• 1 other identifier: U111111946997
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

orthognathic surgery; TMJ; osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  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).

  The clinical evaluations will be performed 7 and 15 days and 1, 3, 6 and 12 months after a treatment application

Secondary Outcomes (2)

• Regeneration of articular cartilage after cellular transplantation

  The imaging tests (by computed tomography) will be performed 6 and 12 months after the cellular transplantation

• 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

Study Arms (1)

autologous chondrocyte transplantation

EXPERIMENTAL

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.

Biological: Autologous chondrocyte transplantation; Procedure: orthognathic surgery

Interventions

Autologous chondrocyte transplantation BIOLOGICAL

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

autologous chondrocyte transplantation

orthognathic surgery PROCEDURE

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

autologous chondrocyte transplantation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pregnant or breastfeeding;
• infection or other comorbidities;
• rheumatologic diseases;
• chronic pain in another joint;
• chronic use of corticosteroids and immunosuppressants.

Sponsors & Collaborators

• Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto: lead

Study Sites (1)

Faculdade de Medicina de Petrópolis

Petrópolis, Rio de Janeiro, 25680120, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Osteoarthritis

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Radovan Borojevic

  Faculty of Medicine of Petrópolis

  STUDY CHAIR

• Paulo Guimarães

  Faculty of Medicine of Petrópolis

  STUDY DIRECTOR

• Ricardo Tesch

  Faculty of Medicine of Petrópolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 3, 2017
• Study Start: May 8, 2015
• Primary Completion: May 8, 2016
• Study Completion: December 2, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

BR (1)