Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

Temporomandibular Joint Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137914
• Other study ID #: U111111946997
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2015
• Est. completion date: December 2, 2020

Study information

• Verified date: February 2021
• Source: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2, 2020
• Est. primary completion date: May 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Petrópolis	Petropolis	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Regeneration of articular cartilage after cellular transplantation	The participant will be submitted to the image examination (computed tomography) for evaluation of the articular osteochondral tissue.	The imaging tests (by computed tomography) will be performed 6 and 12 months after the cellular transplantation
Secondary	Improvement of the researcher's quality of life after cell transplantation over 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.	The questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months