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Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

ABSTRACT: BACKGROUND:Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. METHODS:We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. RESULTS:A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05). CONCLUSIONS:This study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size. TRIAL REGISTRATION:NCT01357785 Date registered: 18 May 2011.

SUBMITTER: Chen FM

PROVIDER: S-EPMC4761216 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

Chen Fa-Ming FM Gao Li-Na LN Tian Bei-Min BM Zhang Xi-Yu XY Zhang Yong-Jie YJ Dong Guang-Ying GY Lu Hong H Chu Qing Q Xu Jie J Yu Yang Y Wu Rui-Xin RX Yin Yuan Y Shi Songtao S Jin Yan Y

Stem cell research & therapy 20160219

<h4>Background</h4>Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament st ...[more]

PMID: 26895633

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Project description:BackgroundIn the regenerative treatment of intrabony periodontal defects, surgical strategies are primarily determined by defect morphologies. In certain cases, however, direct clinical measurements and intraoral radiographs do not provide sufficient information on defect morphologies. Therefore, the application of cone-beam computed tomography (CBCT) has been proposed in specific cases. 3D virtual models reconstructed with automatic thresholding algorithms have already been used for diagnostic purposes. The aim of this study was to utilize 3D virtual models, generated with a semi-automatic segmentation method, for the treatment planning of minimally invasive periodontal surgeries and to evaluate the accuracy of the virtual models, by comparing digital measurements to direct intrasurgical measurements.MethodsFour patients with a total of six intrabony periodontal defects were enrolled in the present study. Two months following initial periodontal treatment, a CBCT scan was taken. The novel semi-automatic segmentation method was performed in an open-source medical image processing software (3D Slicer) to acquire virtual 3D models of alveolar and dental structures. Intrasurgical and digital measurements were taken, and results were compared to validate the accuracy of the digital models. Defect characteristics were determined prior to surgery with conventional diagnostic methods and 3D virtual models. Diagnostic assessments were compared to the actual defect morphology during surgery.ResultsDifferences between intrasurgical and digital measurements in depth and width of intrabony components of periodontal defects averaged 0.31 ± 0.21 mm and 0.41 ± 0.44 mm, respectively. In five out of six cases, defect characteristics could not be assessed precisely with direct clinical measurements and intraoral radiographs. 3D models generated with the presented semi-automatic segmentation method depicted the defect characteristics correctly in all six cases.ConclusionIt can be concluded that 3D virtual models acquired with the described semi-automatic segmentation method provide accurate information on intrabony periodontal defect morphologies, thus influencing the treatment strategy. Within the limitations of this study, models were found to be accurate; however, further investigation with a standardized validation process on a large number of participants has to be conducted.

Project description:ObjectivesThis study aims to compare the treatment outcomes of periodontal intrabony defects by using platelet-rich fibrin (PRF) with other commonly utilized modalities.Materials and methodsThe eligibility criteria comprised randomized controlled trials (RCTs) comparing the clinical outcomes of PRF with that of other modalities. Studies were classified into 10 categories as follows: (1) open flap debridement (OFD) alone versus OFD/PRF; (2) OFD/bone graft (OFD/BG) versus OFD/PRF; (3) OFD/BG versus OFD/BG/PRF; (4-6) OFD/barrier membrane (BM), OFD/PRP, or OFD/enamel matrix derivative (EMD) versus OFD/PRF; (7) OFD/EMD versus OFD/EMD/PRF; (8-10) OFD/PRF versus OFD/PRF/metformin, OFD/PRF/bisphosphonates, or OFD/PRF/statins. Weighted means and forest plots were calculated for probing depth (PD), clinical attachment level (CAL), and radiographic bone fill (RBF).ResultsFrom 551 articles identified, 27 RCTs were included. The use of OFD/PRF statistically significantly reduced PD and improved CAL and RBF when compared to OFD. No clinically significant differences were reported when OFD/BG was compared to OFD/PRF. The addition of PRF to OFD/BG led to significant improvements in CAL and RBF. No differences were reported between any of the following groups (OFD/BM, OFD/PRP, and OFD/EMD) when compared to OFD/PRF. No improvements were also reported when PRF was added to OFD/EMD. The addition of all three of the following biomolecules (metformin, bisphosphonates, and statins) to OFD/PRF led to statistically significant improvements of PD, CAL, and RBF.ConclusionsThe use of PRF significantly improved clinical outcomes in intrabony defects when compared to OFD alone with similar levels being observed between OFD/BG and OFD/PRF. Future research geared toward better understanding potential ways to enhance the regenerative properties of PRF with various small biomolecules may prove valuable for future clinical applications. Future research investigating PRF at histological level is also needed.Clinical relevanceThe use of PRF in conjunction with OFD statistically significantly improved PD, CAL, and RBF values, yielding to comparable outcomes to OFD/BG. The combination of PRF with bone grafts or small biomolecules may offer certain clinical advantages, thus warranting further investigations.

Project description:BackgroundThe concept of periodontal regeneration has been revolutionised since the introduction of growth factors and bioactive bone substitutes which ensures optimal regeneration of the diseased periodontium. The aim of the present study was to evaluate the efficacy of Amniotic membrane + Biphasic Calcium phosphate as compared to Collagen membrane + Biphasic Calcium phosphate for the management of periodontal intrabony defects.Methods50 systemically healthy patients with localised moderate to severe periodontitis, sites which had a Probing Pocket Depth (PPD) ≥ 6 mm and an intrabony component of ≥ 3 mm as detected on Intra oral periapical radiographs (IOPAR) and bone sounding were recruited based on specific inclusion and exclusion criteria. They were randomly allocated by computer generated tables to Collagen membrane + Biphasic Calcium phosphate and Amniotic membrane + Biphasic Calcium phosphate groups. The amount of bone fill and changes in Probing Pocket Depth, Clinical Attachment Level were measured at baseline and six months.ResultsThe results of the present study showed a mean reduction in the PPD of 2.89 ± 0.69 mm in the Collagen membrane + Biphasic Calcium phosphate group and 2.95 ± 0.57 mm in the Amniotic membrane + Biphasic Calcium phosphate group and CAL gain of 2.60 ± 1.43 mm in Collagen membrane + Biphasic Calcium phosphate group 3.18 ± 1.13 mm in the Amniotic membrane + Biphasic Calcium phosphate group at 6 months follow-up with no statistical significance between the groups. In terms of Defect resolution, 98.62 ± 6.51 % was achieved in Collagen membrane + Biphasic Calcium phosphate group and 98.25 ± 7.21 % in Amniotic membrane + Biphasic Calcium phosphate group.ConclusionsWithin the limitations of the present study, it can be concluded that AM can be used as a barrier membrane, in conjunction with Biphasic calcium phosphate, and provides comparable results to Collagen membrane with Biphasic calcium phosphate when used in the management of periodontal intrabony defects.

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Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

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Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

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