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Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery

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ClinicalTrials.gov Identifier: NCT03137914
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Biological: Autologous chondrocyte transplantation Procedure: orthognathic surgery Phase 1

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2015
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


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).
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




Primary Outcome Measures :
  1. Change in participant's clinical status 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 participant will be evaluated clinically to verify the intensity and severity of pain as well as the functional incapacity of the temporomandibular joint, through the system used for the diagnostic classification "Research Diagnostic Criteria for Temporomandibular Disorders" (RDC/TMD).


Secondary Outcome Measures :
  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. The researchers will evaluate: 1) Degree of filling of the defect based on the thickness of the repair tissue and 2) Degree of integration of the repair tissue with adjacent cartilage.

  2. Change in participant'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 improvement of pain, mobility, degree of independence and satisfaction with experimental treatment.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137914


Contacts
Contact: Ricardo Tesh 1521988700743 rdtesch@ig.com.br
Contact: Roberta Sttum 552499999-7659 coppex.roberta@fmpfase.edu.br

Locations
Brazil
Faculdade de Medicina de Petrópolis Recruiting
Petropolis, Rio de Janeiro, Brazil, 25680120
Contact: Ricardo Tesch    2198870-0743    rdtesch@ig.com.br   
Contact: Karla Menezes    21971876657    karlamenezess@gmail.com   
Principal Investigator: Ricardo Tesch         
Sub-Investigator: Radovan Borojevic         
Sub-Investigator: Esther Takamori         
Sub-Investigator: Karla Menezes         
Sub-Investigator: Rosana Bizon         
Sub-Investigator: Claudio Dutra         
Sub-Investigator: Tania Torraca         
Sub-Investigator: Marcelo Aguiar         
Sub-Investigator: Edelton Antunes         
Sponsors and Collaborators
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

Responsible Party: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
ClinicalTrials.gov Identifier: NCT03137914     History of Changes
Other Study ID Numbers: U111111946997
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto:
orthognathic surgery
TMJ
osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents