Clinical Trials of Regeneration for Periodontal Tissue
Clinical Trial of Regenerative Periodontal Tissue by Transplanting Mesenchymal Stem Cells and Osteoblast Cells - I, II Phase-
1 other identifier
interventional
10
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFebruary 9, 2009
February 1, 2009
September 13, 2005
February 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alveolar bone defect
Secondary Outcomes (1)
Tooth mobility
Interventions
Eligibility Criteria
You may qualify if:
- Patient with adult periodontitis. 2. There are ４mm or more pocket using . 3.There are ten existing tooth or more of the lower jaw. 4.The brushing instruction is received, and the plaque control is maintained excellently. 5.The recovery by an existing periodontal operation cannot be expected. 6.The age is from 35 to 60 years old. 7.Blood clot function is normal. 8.The liver function is normal. 9.The intention and the ability of going to hospital regularly are possessed. 10.Agreement by the document is obtained.
You may not qualify if:
- Patient who has acute symptom of periodontitis. 2.Patient that decayed tooth is on teeth or the next teeth to be treated. 3.Patient who has contracted diabetic or autoimmune disease. 4.Patient who has contracted infectious disease. 5.Patient who has contracted osteoporosis. 6.Patient who has smoking habit within six months before it registers. 7.Patient who is taking treatment of hypertension and/or epilepsy. 8.Patient who has pregnancy or doubt of pregnancy. 9.Patient who has heavy allergic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japanlead
- ArBlast Co.,Ltd.collaborator
- Nagoya Universitycollaborator
Study Sites (1)
Ｉｎstitute of Biomedical Research and Innovation
Kobe, Hyogo Pref., 650-0047, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shunsuke Baba, D.D.S, PhD
Ｉｎstitute of Biomedical Research and Innovation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
July 1, 2004
Study Completion
December 1, 2005
Last Updated
February 9, 2009
Record last verified: 2009-02