Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

NCT01082822 | Unknown Phase 1 DMC

• 1 other identifier: TEFMMU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

cell sheet PDLSC periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  Sept. 2009

Study Arms (3)

standard of care

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.

Biological: cell sheet pellets and cell sheet fragment

PDLSC cell sheet transplantion

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.

Biological: cell sheet pellets and cell sheet fragment

the bio-ss implantation

EXPERIMENTAL

implantation of Bioss at post surgical treatment

Biological: cell sheet pellets and cell sheet fragment

Interventions

cell sheet pellets and cell sheet fragment BIOLOGICAL

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

Also known as: cell sheet or pellet implantation

PDLSC cell sheet transplantion; standard of care; the bio-ss implantation

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 19534606 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Jin, PHD

  Research and Development Center for Tissue Engineering, Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 9, 2010

Record last verified: 2009-10

Locations

CN (1)