Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
March 8, 2010 updated by: Air Force Military Medical University, China
Cell sheet technique possess the properties of conserving the ECM, rich molecules and retaining cell vitality, and will promote the capacity of cell adhesion and proliferation.
The stem cell based cell sheet therapy has been utilized in many fields and scored the satisfactory results.
Periodontitis is a chronic disease which causes the destruction of the periodontal tissue and leads to the teeth loss in the end.
The routine cell-based therapy to the periodontitis was confronted with many difficulties.
In the investigators previous preclinical research, +the investigators fabricated periodontal ligament stem cell (PDLSC) pellets and cell sheet fragment and applied them in the periodontal defect area for tissue regeneration and periodontitis treatment.
And the investigators carried out a comprehensive study of the PDLSC allograft.
The host responses and implanted cell fates were recorded.
After the scientific investigation of the preclinical study, the investigators designed the preliminary clinical trial of PDLSC cell sheet for the chronic periodontitis therapy in the aims to test the PDLSC fates and explore one ideal transplantation mode.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
our protocol mainly includes following steps:
- select periodontitis patients :all patients were given the comprehensive examination on the oral condition including clinical examination, radiological evaluation and the immune system tests
- select healthy donor teeth for PDLSC isolation and expansion.
- fabricate the cell sheet and prepare the PDLSC cell sheet pellets and cell sheet fragment.
- 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.
- all the operations were carried out as the routine GBR procedures.
- 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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Research and Develop Center for Tissue Engineering, Fourth Military Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult chronic periodontitis
- pathological lesion is stable after the routine mechanical and chemical treatment.
- the local pathological lesion has the subbony defect
- the oral heath was kept approved.
- there are more 2 teeth with the continued lesion
Exclusion Criteria:
- the age>50 year or < 40year
- the patient has the genetic background of the periodontitis.
- the bone destruction was larger than 2/3 of the root length.
- the preclinical treatment was stable.
- the severe systematic diseases.
- the patients who can not cooperate with the whole the observation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Sham Comparator: 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.
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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 Names:
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Experimental: 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.
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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 Names:
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Experimental: the bio-ss implantation
implantation of Bioss at post surgical treatment
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The Plaque Index was mean score of each surface. Probing depth and Attachment loss are distance from the base of the sulcus and the cemento-enamel junction to the free gingival margin. bone loss
Time Frame: Sept. 2009
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Sept. 2009
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yan Jin, PHD, Research and Development Center for Tissue Engineering, Fourth Military Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
November 1, 2011
Study Completion (Anticipated)
January 1, 2012
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 8, 2010
First Posted (Estimate)
March 9, 2010
Study Record Updates
Last Update Posted (Estimate)
March 9, 2010
Last Update Submitted That Met QC Criteria
March 8, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEFMMU
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