Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatment cell sheet pellets and cell sheet fragment
Phase phase 1/phase 2
Sponsor Fourth Military Medical University
Start date January 2010
End date November 2011
Trial size 80 participants
Trial identifier NCT01082822, TEFMMU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Sham Comparator)
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 cell sheet or pellet implantation
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
(Experimental)
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 cell sheet or pellet implantation
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
(Experimental)
implantation of Bioss at post surgical treatment
cell sheet pellets and cell sheet fragment cell sheet or pellet implantation
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 40 years up to 50 years old.

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.

Additional Information

Official title Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
Principal investigator Yan Jin, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Fourth Military Medical University.