Clinical Trials of Regeneration for Periodontal Tissue

Adult Periodontitis Clinical Trial

Official title:

Clinical Trial of Regenerative Periodontal Tissue by Transplanting Mesenchymal Stem Cells and Osteoblast Cells - I, II Phase-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221130
• Other study ID #: BRI PDT03-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: February 6, 2009
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: February 2009
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Periodontitis
• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• surgical operation of cell transplantation

Locations

Country	Name	City	State
Japan	Institute of Biomedical Research and Innovation	Kobe	Hyogo Pref.

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	ArBlast Co.,Ltd., Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar bone defect
Secondary	Tooth mobility

External Links

•   Introduction of theFoundation for Biomedical Research and Innovation