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Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Fourth Military Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01082822
First received: March 8, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Periodontitis
 Biological: cell sheet pellets and cell sheet fragment
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

Further study details as provided by Fourth Military Medical University:

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 [ Time Frame: Sept. 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Biological: 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 Name: cell sheet or pellet implantation
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.
 Biological: 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 Name: cell sheet or pellet implantation
Experimental: the bio-ss implantation
implantation of Bioss at post surgical treatment
 Biological: 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 Name: cell sheet or pellet implantation

Detailed Description:

our protocol mainly includes following steps:

  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.
  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082822

Locations
China, Shaanxi
Research and Develop Center for Tissue Engineering, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yan Jin, PHD Research and Development Center for Tissue Engineering, Fourth Military Medical University
  More Information

Publications:

Responsible Party: Professor Yan Jin, Research and Development Center for Tissue Engineering, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01082822     History of Changes
Other Study ID Numbers: TEFMMU
Study First Received: March 8, 2010
Last Updated: March 8, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
cell sheet PDLSC periodontitis

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013