Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
NCT ID: NCT01082822
Last Updated: 2010-03-09
Study Results
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Basic Information
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UNKNOWN
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2010-01-31
2012-01-31
Brief Summary
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Detailed Description
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1. select periodontitis patients :all patients were given the comprehensive examination on the oral condition including clinical examination, radiological evaluation and the immune system tests
2. select healthy donor teeth for PDLSC isolation and expansion.
3. fabricate the cell sheet and prepare the PDLSC cell sheet pellets and cell sheet fragment.
4. patients given the routine mechanical and chemical treatment for 4 weeks were randomized divided into 4 groups according to the visit time: i) the cell sheet fragment plus bio-ss transplantation; ii) the cell sheet pellets plus bioss transplantation; iii) the bio-ss transplantation and iv) the control.
5. all the operations were carried out as the routine GBR procedures.
6. the clinical, radiological examination and the changes of the immune system at the point of 1 day before and 4weeks, 12weeks, 24weeks and one year after the intervention were recorded and compared.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PDLSC cell sheet transplantion
Periodontal ligament stem cell derived cell sheet or pellet with carrier such as Bioss was implanted into periodontal defect area at post surgical treatment.
cell sheet pellets and cell sheet fragment
the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area
the bio-ss implantation
implantation of Bioss at post surgical treatment
cell sheet pellets and cell sheet fragment
the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area
standard of care
In the first step, the patient was periodontally treated until the inflammation was eliminated through control of bacterial biofilm and oral hygiene for about 6 months. Then the rigid fixed appliances were placed on the diseased teeth, reverse beveled open-flap surgery was performed in the buccal and palatal maxillary sides of the periodontitis-caught teeth to allow granulation tissue debridement and proper root preparation. The roots were completely scaled, and 17%EDTA was applied for 2 minutes to demineralize the root surfaces and bone wall defects, the flap was sutured.
cell sheet pellets and cell sheet fragment
the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area
Interventions
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cell sheet pellets and cell sheet fragment
the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. pathological lesion is stable after the routine mechanical and chemical treatment.
3. the local pathological lesion has the subbony defect
4. the oral heath was kept approved.
5. there are more 2 teeth with the continued lesion
Exclusion Criteria
2. the patient has the genetic background of the periodontitis.
3. the bone destruction was larger than 2/3 of the root length.
4. the preclinical treatment was stable.
5. the severe systematic diseases.
6. the patients who can not cooperate with the whole the observation.
40 Years
50 Years
ALL
Yes
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Research and Development Center for Tissue Engineering, Fourth Military Medical University
Principal Investigators
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Yan Jin, PHD
Role: PRINCIPAL_INVESTIGATOR
Research and Development Center for Tissue Engineering, Fourth Military Medical University
Locations
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Research and Develop Center for Tissue Engineering, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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References
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Yang Z, Jin F, Zhang X, Ma D, Han C, Huo N, Wang Y, Zhang Y, Lin Z, Jin Y. Tissue engineering of cementum/periodontal-ligament complex using a novel three-dimensional pellet cultivation system for human periodontal ligament stem cells. Tissue Eng Part C Methods. 2009 Dec;15(4):571-81. doi: 10.1089/ten.tec.2008.0561.
Other Identifiers
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TEFMMU
Identifier Type: -
Identifier Source: org_study_id
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