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...
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| Format: | Article |
| Language: | English |
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BMC
2016-02-01
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| Series: | Stem Cell Research & Therapy |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13287-016-0288-1 |
| _version_ | 1818422677869690880 |
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| author | Fa-Ming Chen Li-Na Gao Bei-Min Tian Xi-Yu Zhang Yong-Jie Zhang Guang-Ying Dong Hong Lu Qing Chu Jie Xu Yang Yu Rui-Xin Wu Yuan Yin Songtao Shi Yan Jin |
| author_facet | Fa-Ming Chen Li-Na Gao Bei-Min Tian Xi-Yu Zhang Yong-Jie Zhang Guang-Ying Dong Hong Lu Qing Chu Jie Xu Yang Yu Rui-Xin Wu Yuan Yin Songtao Shi Yan Jin |
| author_sort | Fa-Ming Chen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T13:30:04Z |
| format | Article |
| id | doaj.art-7ffcb8f792014221917f6ce789759949 |
| institution | Directory Open Access Journal |
| issn | 1757-6512 |
| language | English |
| last_indexed | 2024-12-14T13:30:04Z |
| publishDate | 2016-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Stem Cell Research & Therapy |
| spelling | doaj.art-7ffcb8f792014221917f6ce7897599492022-12-21T22:59:43ZengBMCStem Cell Research & Therapy1757-65122016-02-017111110.1186/s13287-016-0288-1Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trialFa-Ming Chen0Li-Na Gao1Bei-Min Tian2Xi-Yu Zhang3Yong-Jie Zhang4Guang-Ying Dong5Hong Lu6Qing Chu7Jie Xu8Yang Yu9Rui-Xin Wu10Yuan Yin11Songtao Shi12Yan Jin13State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityState Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical UniversityDepartment of Anatomy and Cell Biology, School of Dental Medicine, University of PennsylvaniaState Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical UniversityAbstract 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.http://link.springer.com/article/10.1186/s13287-016-0288-1Stem cell-therapyPeriodontitisPeriodontal regenerationCell sheetTissue engineeringTranslational medicine |
| spellingShingle | Fa-Ming Chen Li-Na Gao Bei-Min Tian Xi-Yu Zhang Yong-Jie Zhang Guang-Ying Dong Hong Lu Qing Chu Jie Xu Yang Yu Rui-Xin Wu Yuan Yin Songtao Shi Yan Jin Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial Stem Cell Research & Therapy Stem cell-therapy Periodontitis Periodontal regeneration Cell sheet Tissue engineering Translational medicine |
| title | Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial |
| title_full | Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial |
| title_fullStr | Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial |
| title_full_unstemmed | Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial |
| title_short | Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial |
| title_sort | treatment of periodontal intrabony defects using autologous periodontal ligament stem cells a randomized clinical trial |
| topic | Stem cell-therapy Periodontitis Periodontal regeneration Cell sheet Tissue engineering Translational medicine |
| url | http://link.springer.com/article/10.1186/s13287-016-0288-1 |
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