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Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
cell sheet pellets and cell sheet fragment
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring cell sheet PDLSC periodontitis

Eligibility Criteria

40 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. adult chronic periodontitis
  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:

  1. the age>50 year or < 40year
  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.

Sites / Locations

  • Research and Develop Center for Tissue Engineering, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

standard of care

PDLSC cell sheet transplantion

the bio-ss implantation

Arm Description

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.

Periodontal ligament stem cell derived cell sheet or pellet with carrier such as Bioss was implanted into periodontal defect area at post surgical treatment.

implantation of Bioss at post surgical treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2010
Last Updated
March 8, 2010
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01082822
Brief Title
Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
Official Title
Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
cell sheet PDLSC periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
PDLSC cell sheet transplantion
Arm Type
Experimental
Arm Description
Periodontal ligament stem cell derived cell sheet or pellet with carrier such as Bioss was implanted into periodontal defect area at post surgical treatment.
Arm Title
the bio-ss implantation
Arm Type
Experimental
Arm Description
implantation of Bioss at post surgical treatment
Intervention Type
Biological
Intervention Name(s)
cell sheet pellets and cell sheet fragment
Other Intervention Name(s)
cell sheet or pellet implantation
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Jin, PHD
Organizational Affiliation
Research and Development Center for Tissue Engineering, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research and Develop Center for Tissue Engineering, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19534606
Citation
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.
Results Reference
background

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Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

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