Clinical trial NCT03137914: Nasal Septum Autologous Chondrocytes Transplantation for Condylar Resorption After Orthognathic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Temporomandibular Joint Disorders
Keywords: orthognathic surgery
TMJ
osteoarthritis
Lead sponsor: Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical improvement of the research participant after cell transplantation over 12 months
timeFrame: The clinical evaluations will be performed 7 and 15 days and 1, 3, 6 and 12 months after a treatment application
Secondary outcomes:
measure: Regeneration of articular cartilage after cellular transplantation
timeFrame: The imaging tests (by computed tomography) will be performed 6 and 12 months after the cellular transplantation
measure: Improvement of the researcher's quality of life after cell transplantation over 12 months
timeFrame: The questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Petropolis
country: Brazil
facility: Faculdade de Medicina de Petrópolis
state: Rio De Janeiro
Study officials:
affiliation: Faculty of Medicine of Petrópolis
name: Radovan Borojevic
role: STUDY_CHAIR
affiliation: Faculty of Medicine of Petrópolis
name: Paulo Guimarães
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine of Petrópolis
name: Ricardo Tesch
role: PRINCIPAL_INVESTIGATOR
References: