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临床试验/NCT03137914
NCT03137914已完成1 期

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

Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年5月8日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Clinical improvement of the research participant after cell transplantation over 12 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of dentofacial deformities related to osteoarthritis of TMJ;
  • must have surgical indication.

排除标准

  • pregnant or breastfeeding;
  • infection or other comorbidities;
  • rheumatologic diseases;
  • chronic pain in another joint;
  • chronic use of corticosteroids and immunosuppressants.

结局指标

主要结局

Clinical improvement of the research participant after cell transplantation over 12 months

时间窗: 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).

次要结局

  • Regeneration of articular cartilage after cellular transplantation(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 questionnaires will be applied will be performed 7 and 15 days and 1, 3, 6 and 12 months)

研究者

发起方
Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto
申办方类型
Other
责任方
Sponsor

研究点 (2)

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