Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Biological: Autologous chondrocyte transplantation; Procedure: orthognathic surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro
    • Petropolis, Rio De Janeiro, Brazil, 25680120
      • Faculdade de Medicina de Petrópolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
• Investigators: Study Chair: Radovan Borojevic, Faculty of Medicine of Petrópolis; Study Director: Paulo Guimarães, Faculty of Medicine of Petrópolis; Principal Investigator: Ricardo Tesch, Faculty of Medicine of Petrópolis

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2015
• Primary Completion (Actual): May 8, 2016
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; TMJ; orthognathic surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: U111111946997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No