Clinical Trials of Regeneration for Periodontal Tissue
Procedure: surgical operation of cell transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Regenerative Periodontal Tissue by Transplanting Mesenchymal Stem Cells and Osteoblast Cells - I, II Phase-|
- Alveolar bone defect
- Tooth mobility
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||December 2005|
Periodontal disease is an infectious disease. Gingivitis and periodontitis are the 2 major forms of this. Their primary etiology is bacterial plaque, which can induce destruction of the periodontal apparatus. Gingivitis is inflammation of the gingival that does not result in clinical attachment loss. Periodontitis is inflammation of the gingival and is characterized by loss of connective tissue attachment and alveolar bone.
Therapeutic approaches for periodontitis are divided into two categories: 1) anti-infective treatment; 2) regenerative therapy.
Several surgical techniques have been developed to regenerate periodontal tissues including guided tissue regeneration, bone grafting, the use of enamel matrix derivative. However, these techniques are not reached for complete regeneration of the periodontium.
This study will test the safety and efficacy of alveolous bone reproduction by the transplantation of mixture named periodontium injectable gel for the adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221130
|Ｉｎstitute of Biomedical Research and Innovation|
|Kobe, Hyogo Pref., Japan, 650-0047|
|Principal Investigator:||Shunsuke Baba, D.D.S, PhD||Ｉｎstitute of Biomedical Research and Innovation|