Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221130
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-09-13
Brief Title:
Clinical Trials of Regeneration for Periodontal Tissue
Sponsor:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Organization:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Study Overview
Official Title:
Clinical Trial of Regenerative Periodontal Tissue by Transplanting Mesenchymal Stem Cells and Osteoblast Cells - I II Phase-
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adult periodontitis is a chronic infective disease affecting the periodontium Periodontitis induce the destruction of attachment apparatus of teeth resulting in periodontal pocket formation and teeth loss 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None