Periodontal Tissue Regeneration Using Autologous Periodontal Ligament Stem Cells (PDLSC)
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ClinicalTrials.gov Identifier: NCT01357785
Recruitment Status : Unknown
Verified September 2011 by Fa-Ming Chen, Fourth Military Medical University. Recruitment status was: Recruiting
The purpose of this clinical trial is to both clarify the efficiency of autologous periodontal ligament (PDL) stem cells to regenerate periodontal tissue in periodontitis patients with deep intraosseous defects (>5 mm) and to confirm the safety of using autologous stem cells in clinical periodontal regenerative medicine. This is a single-centre, randomized, placebo-controlled study. This study has been approved by the ethical committees of School of Stomatology, Fourth Military Medical University. The study will be conducted according to the Declaration of Helsinki.
Periodontal bone regeneration [ Time Frame: 1 year ]
The main outcome measures in the study protocol were: rate of increase in alveolar bone height and millimeter of clinical attachement level (CAL) regained. In addition, we examined whether and to what extent adverse events, for which causal relationships with the use of PDL cell were not ruled out, emerged. We set rate of increase in alveolar bone height as the most statistically important outcome (primary outcome).
Secondary Outcome Measures :
Clinical parameters [ Time Frame: 3 months -12 months ]
pocket depth (PD), attachment level (AL), and tooth mobility (TM)
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Those diagnosed as having, from radiography and other results, 2- or 3-walled vertical intrabony defect 3 mm deep from the top of the remaining alveolar bone
Those who have accomplished initial preparation and have been showing good compliance
Those with mobility of the tooth to investigate of Degree 2 or less and with width of attached gingiva for which the existing Guided Tissue Regeneration (GTR) and bone graft implantation treatment are considered appropriate
Those for whom supportive periodontal treatment is applicable (the tooth has the potential to be maintain for at least 3 years), in accordance with usual post-operative procedures following flap operation and GTR treatment
Those whose oral hygiene is well established and who are able to perform appropriate tooth brushing and cleaning following instructions of the investigators and/or sub-investigators after investigational drug administration
Those 18-years-old and <65-years-old Those who has at least one tooth (e.g. wisdom tooth) that is need to be extracted and the patient agrees the tooth extraction.
Those who understand the purposes of the trial and are capable of making an independent decision to comply with trial requirements
Those who are able to visit our hospital in accordance with the trial schedule
Those administered a calcium antagonist during the 4 weeks preceding the surgery
Those in need of administration of adrenal cortical steroid (equivalent to>20 mg/day of Predonin) within 4 weeks after the surgery
Those scheduled to undergo a surgical operation in the vicinity of the tooth to investigate within 36 weeks after surgery
Those with coexisting mental or consciousness disorder
Those with coexisting malignant tumour or history of the same
Those with coexisting diabetes (HbA1C >6.5%)
Those in an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
Those with 200 mL of blood drawn during the 4 weeks preceding the surgery
Those administered another investigational drug during the 24 h preceding investigational drug administration
Those with coexisting disorder of the kidney, liver, blood and/or circulatory system (Grade 2 or above)
Those who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial
Those with a previous history of hypersensitivity to any biological active drugs
Those who smoke more than 10 pieces of cigarettes
Those who are involved in the research team of this trial
Others who the investigators or sub-investigators determined as unsuitable for the trial