Dataset Information

Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial.

ABSTRACT: Periodontitis is an inflammatory process in response to dental biofilm and leads to periodontal tissue destruction. The aim of this study was the comparison of outcomes using either an enamel matrix derivative (EMD) or a nanocrystalline hydroxyapatite (NHA) in regenerative periodontal therapy after 6 and 12 months.Using a parallel group, prospective randomized study design, we enrolled 19 patients in each group. The primary outcome was bone fill after 12 months. Attachment gain, probing pocket depth (PPD) reduction, and recession were secondary variables. Additionally, early wound healing and adverse events were assessed. Data analysis included test of noninferiority of NHA group (test) compared to EMD group (reference) in bone fill. Differences in means of secondary variables were compared by paired t-test, frequency data by exact ?(2) test.Both groups showed significant bone fill, reduction of PPD, increase in recession, and gain of attachment after 6 and 12 months. No significant differences between groups were found at any time point. Adverse events were comparable between both groups with a tendency of more complaints in the NHA group.The clinical outcomes were similar in both groups. EMD could have some advantage compared to NHA regarding patients comfort and adverse events. The trial is registered with ClinicalTrials.gov NCT00757159.

SUBMITTER: Al Machot E

PROVIDER: S-EPMC3932837 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial.

Al Machot Elyan E Hoffmann Thomas T Lorenz Katrin K Khalili Ihssan I Noack Barbara B

BioMed research international 20140209

<h4>Introduction</h4>Periodontitis is an inflammatory process in response to dental biofilm and leads to periodontal tissue destruction. The aim of this study was the comparison of outcomes using either an enamel matrix derivative (EMD) or a nanocrystalline hydroxyapatite (NHA) in regenerative periodontal therapy after 6 and 12 months.<h4>Methods</h4>Using a parallel group, prospective randomized study design, we enrolled 19 patients in each group. The primary outcome was bone fill after 12 mont ...[more]

PMID: 24689056

Similar Datasets

Project description:The combination of enamel matrix derivative (EMD) with an autogenous bone graft in periodontal regeneration has been proposed to improve clinical outcomes, especially in case of deep non-contained periodontal defects, with variable results. The aim of the present systematic review and meta-analysis was to assess the efficacy of EMD in combination with autogenous bone graft compared with the use of EMD alone for the regeneration of periodontal intrabony defects. A literature search in PubMed and in the Cochrane Central Register of Controlled Trials was carried out on February 2019 using an ad-hoc search string created by two independent and calibrated reviewers. All randomized controlled trials (RCTs) comparing a combination of EMD and autogenous bone graft with EMD alone for the treatment of periodontal intrabony defects were included. Studies involving other graft materials were excluded. The requested follow-up was at least 6 months. There was no restriction on age or number of patients. Standard difference in means between test and control groups as well as relative forest plots were calculated for clinical attachment level gain (CALgain), probing depth reduction (PDred), and gingival recession increase (RECinc). Three RCTs reporting on 79 patients and 98 intrabony defects were selected for the analysis. Statistical heterogeneity was detected as significantly high in the analysis of PDred and RECinc (I2 = 85.28%, p = 0.001; I2 = 73.95%, p = 0.022, respectively), but not in the analysis of CALgain (I2 = 59.30%, p = 0.086). Standard difference in means (SDM) for CALgain between test and control groups amounted to -0.34 mm (95% CI -0.77 to 0.09; p = 0.12). SDM for PDred amounted to -0.43 mm (95% CI -0.86 to 0.01; p = 0.06). SDM for RECinc amounted to 0.12 mm (95% CI -0.30 to 0.55. p = 0.57). Within their limits, the obtained results indicate that the combination of enamel matrix derivative and autogenous bone graft may result in non-significant additional clinical improvements in terms of CALgain, PDred, and RECinc compared with those obtained with EMD alone. Several factors, including the surgical protocol used (e.g. supracrestal soft tissue preservation techniques) could have masked the potential additional benefit of the combined approach. Further well-designed randomized controlled trials, with well-defined selection criteria and operative protocols, are needed to draw more definite conclusions.

Project description:BackgroundPeriodontitis, 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.MethodsWe 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.ResultsA 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).ConclusionsThis 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 registrationNCT01357785 Date registered: 18 May 2011.

Dataset Information

Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial.

Publications

Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets