Clinical Trials of Regeneration for Periodontal Tissue - Full Text View

Sponsors and Collaborators:	Translational Research Informatics Center, Kobe, Hyogo, Japan ArBlast Co.,Ltd. Nagoya University
Information provided by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00221130

Purpose

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).

Condition	Intervention	Phase
Adult Periodontitis	Procedure: surgical operation of cell transplantation	Phase I Phase II

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial of Regenerative Periodontal Tissue by Transplanting Mesenchymal Stem Cells and Osteoblast Cells - I, II Phase-

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:

Alveolar bone defect

Secondary Outcome Measures:

Tooth mobility

Estimated Enrollment:	10
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2005

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).

Eligibility

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1.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.

Exclusion Criteria:

1.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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221130

Locations

Japan, Hyogo Pref.
Ｉｎstitute of Biomedical Research and Innovation
Kobe, Hyogo Pref., Japan, 650-0047

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

ArBlast Co.,Ltd.

Nagoya University

Investigators

Principal Investigator:

Shunsuke Baba, D.D.S, PhD

Ｉｎstitute of Biomedical Research and Innovation

More Information

Introduction of theFoundation for Biomedical Research and Innovation This link exits the ClinicalTrials.gov site

Study ID Numbers:	BRI PDT03-01
Study First Received:	September 13, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00221130
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Regenerative medicine
Periodontal tissue

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 11, 2009