Chronic PeriodontitisPhase 1/2NCT01082822
Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
A Phase 1/2 study testing cell sheet pellets and cell sheet fragment in people with Chronic Periodontitis, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- cell sheet pellets and cell sheet fragment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Research and Develop Center for Tissue Engineering, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- cell sheet pellets and cell sheet fragment
- Keywords
- cell sheet PDLSC periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell sheet pellets and cell sheet fragmentBiological
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: cell sheet pellets and cell sheet fragment |
| the bio-ss implantation | Experimental | implantation of Bioss at post surgical treatment Receives: Biological: cell sheet pellets and cell sheet fragment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Sept. 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Yan Jin, PHD, Principal investigator, Research and Development Center for Tissue Engineering, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082822
- Sponsor's protocol ID
- TEFMMU
- Status last verified
- Oct 2009
- First submitted
- 8 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19534606
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT01082822
- Acronym / sponsor ID
- TEFMMU
- Conditions
- Chronic Periodontitis
- Keywords
- cell sheet PDLSC periodontitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care | Sham comparator | Biological: cell sheet pellets and cell sheet fragmentIn 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. |
| PDLSC cell sheet transplantion | Experimental | Biological: cell sheet pellets and cell sheet fragmentPeriodontal ligament stem cell derived cell sheet or pellet with carrier such as Bioss was implanted into periodontal defect area at post surgical treatment. |
| the bio-ss implantation | Experimental | Biological: cell sheet pellets and cell sheet fragmentimplantation of Bioss at post surgical treatment |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell sheet pellets and cell sheet fragmentAlso: cell sheet or pellet implantationthe 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 | Biological | PDLSC cell sheet transplantion, standard of care, the bio-ss implantation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Background: PubMed 19534606Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Jin, PHD principal investigator
Research and Development Center for Tissue Engineering, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cell sheet pellets and cell sheet fragment in people with Chronic Periodontitis, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.