Temporomandibular Joint DisordersPhase 1NCT03137914
Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery
A Phase 1 study testing Autologous chondrocyte transplantation and orthognathic surgery in people with Temporomandibular Joint Disorders, run by Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Autologous chondrocyte transplantation and orthognathic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2015to 2 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of dentofacial deformities related to osteoarthritis of TMJ;
- must have surgical indication.
Who cannot join
- pregnant or breastfeeding;
- infection or other comorbidities;
- rheumatologic diseases;
- chronic pain in another joint;
- chronic use of corticosteroids and immunosuppressants.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Petrópolis
Petrópolis, Rio de Janeiro, 25680120
About this study
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
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Autologous chondrocyte transplantation, orthognathic surgery
- Keywords
- orthognathic surgery, TMJ, osteoarthritis
- Medical subject headings
- Temporomandibular Joint Disorders, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous chondrocyte transplantationBiological
intraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid
orthognathic surgeryProcedure or surgery
Orthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous chondrocyte transplantation; Procedure: orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 participant will be submitted to the image examination (computed tomography) for evaluation of the articular osteochondral tissue.
Measured: 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.
Measured: The questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start8 May 2015
- Primary completion8 May 2016
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radovan Borojevic, Study chair, Faculty of Medicine of PetrópolisPaulo Guimarães, Study director, Faculty of Medicine of PetrópolisRicardo Tesch, Principal investigator, Faculty of Medicine of Petrópolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137914
- Sponsor's protocol ID
- U111111946997
- Status last verified
- Feb 2021
- First submitted
- 25 Apr 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03137914
- Acronym / sponsor ID
- U111111946997
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- orthognathic surgery, TMJ, osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp NetoUniversity, hospital or other
- Study start
- 8 May 2015 (actual)
- Primary completion
- 8 May 2016 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| autologous chondrocyte transplantation | Experimental | Biological: Autologous chondrocyte transplantation, Procedure: orthognathic surgeryAutologous 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of dentofacial deformities related to osteoarthritis of TMJ;
- must have surgical indication.
Key exclusion criteria (5 listed)
- pregnant or breastfeeding;
- infection or other comorbidities;
- rheumatologic diseases;
- chronic pain in another joint;
- chronic use of corticosteroids and immunosuppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous chondrocyte transplantationintraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid | Biological | autologous chondrocyte transplantation |
| orthognathic surgeryOrthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation | Procedure or surgery | autologous chondrocyte transplantation |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Borojevic study chair
Faculty of Medicine of Petrópolis
Paulo Guimarães study director
Faculty of Medicine of Petrópolis
Ricardo Tesch principal investigator
Faculty of Medicine of Petrópolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous chondrocyte transplantation and orthognathic surgery in people with Temporomandibular Joint Disorders, run by Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.