Dataset Information

Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis.

ABSTRACT: This split-mouth, double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD) after a 24-month follow-up. The radiographic distance from the CEJ to the bottom of the defect (BD) was considered the primary outcome. CEJ-BC and defect angle were secondary outcomes.Ten patients presenting 2 or more defects were selected. An individualized film holder was used to take standardized radiographs of the 43 defects, at baseline and after 24 months. Images were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle. Statistical analysis was performed in SPSS for Windows (version 5.2). Paired samples t test was used to compare test and control groups and to evaluate changes within each group. The level of significance was set at ??=?0.05%.After 24 months, a significant crestal bone loss was observed for EMD (1.01 mm; p?=?0.049) but not for OFD (0.14 mm; p?=?0.622). However, no differences were detected between groups (p?=?0.37). Reduction of the bone defect depth was significant for OFD (0.70 mm; p?=?0.005) but not for EMD (0.04 mm; p?=?0.86), while no differences were detected between them (p?=?0.87). Both EMD (0.69°; p?=?0.82) and OFD (5.71°; p?=?0.24) showed an improvement in defect angle measurements but no significant differences were observed after 24 months or between the groups (p?=?0.35).Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24 months.ClinicalTrials.gov: NCT02195765. Registered 17 July 2014.

SUBMITTER: Ragghianti Zangrando MS

PROVIDER: S-EPMC4266965 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis.

Ragghianti Zangrando Mariana Schutzer MS Chambrone Daniela D Pasin Ivan Munhoz IM Conde Marina Clemente MC Pannuti Cláudio Mendes CM de Lima Luiz Antônio Pugliesi Alves LA

BMC oral health 20141204

<h4>Background</h4>This split-mouth, double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD) after a 24-month follow-up. The radiographic distance from the CEJ to the bottom of the defect (BD) was considered the primary outcome. CEJ-BC and defect angle were secondary outcomes.<h4>Methods</h4>Ten patients presenting 2 or more defects were selected. An individualized ...[more]

PMID: 25475143

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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:Enamel matrix derivative (EMD), a porcine extract harvested from developing porcine teeth, has been shown to promote formation of new cementum, periodontal ligament and alveolar bone. Despite its widespread use, an incredibly large variability among in vitro studies has been observed. The aim of the present study was to determine the influence of EMD on cells at different maturation stages of osteoblast differentiation by testing 6 cell types to determine if cell phenotype plays a role in cell behaviour following treatment with EMD. Six cell types including MC3T3-E1 pre-osteoblasts, rat calvarial osteoblasts, human periodontal ligament (PDL) cells, ROS cells, MG63 cells and human alveolar osteoblasts were cultured in the presence or absence of EMD and proliferation rates were quantified by an MTS assay. Gene expression of collagen1(COL1), alkaline phosphate(ALP) and osteocalcin(OC) were investigated by real-time PCR. While EMD significantly increased cell proliferation of all cell types, its effect on osteoblast differentiation was more variable. EMD significantly up-regulated gene expression of COL1, ALP and OC in cells early in their differentiation process when compared to osteoblasts at later stages of maturation. Furthermore, the effect of cell passaging of primary human PDL cells (passage 2 to 15) was tested in response to treatment with EMD. EMD significantly increased cell proliferation and differentiation of cells at passages 2-5 however had completely lost their ability to respond to EMD by passages 10+. The results from the present study suggest that cell stimulation with EMD has a more pronounced effect on cells earlier in their differentiation process and may partially explain why treatment with EMD primarily favors regeneration of periodontal defects (where the periodontal ligament contains a higher number of undifferentiated progenitor cells) over regeneration of pure alveolar bone defects containing no periodontal ligament and a more limited number of osteoprogenitor cells.

Project description:Vital pulp therapy (VPT) aims to preserve the health and maintain life of the tooth pulp which has been compromised by caries, trauma or restorative procedures. Recently, enamel matrix derivative (EMD) has been introduced as a material for vital pulp therapy. The aim of this review is to critically analyze and summarize the available literature on EMD for VPT.Online databases (PubMED/MEDLINE, Google Scholar, ISI Web of Science, and Wiley-Online) were searched by using the following keywords in various combinations: Enamel Matrix Derivative, Emdogain, 'Vital Pulp Therapy, 'Apexogenisis', Apexification, Pulp Capping, Endodontics, Dentine and Pulpotomy for studies indexed from January 1949 to April 2016. We used an English-limited search in Google.co.uk for the missing grey literature. All studies fulfilling the selection criteria were carefully reviewed for the focused question: "Does using EMD in VPT, compared with other materials, result in better clinical, radiographic and histological outcomes?".The primary search resulted in 18 articles of which, 14 articles (including 6 animal studies and 6 clinical trials and 2 case reports) met the inclusion criteria for this review and hence were included. The number of teeth tested in the animal studies ranged from 8 to 144 including pigs, rats and dogs teeth. A number of studies used EMD in the experimental group in comparison with calcium hydroxide, propylene glycol alginate (PGA) and MTA as a control. The observation period ranged from 1 to 2 months and 4 out of 6 animal trials reported more favorable outcomes with EMD while two studies reported comparable outcomes.Although EMD has potential for various applications in endodontics, studies conducted to date have failed to demonstrate any significant advantage of EMD over conventional VPT materials. Additionally, the 5-year and 10-year survival rate of EMD-treated teeth is not yet known. Hence, studies with a longer follow-up periods are required to deduce the long-term viability of teeth treated with EMD.

Project description:Importance:Enamel defects of developmental origin affect up to 38% of schoolchildren and is recognized as a global public health challenge. The impaired enamel formation results in pain owing to hypersensitivity, posteruptive breakdowns, rapid caries progression, and extractions in some cases. The etiology is unknown; therefore, prevention is currently not possible. Objective:To assess the association of a high-dose vitamin D supplementation in pregnant women with enamel defects and caries in their offspring. Design, Setting, and Participants:Post hoc analysis of a double-blind, single-center, randomized clinical trial, the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort (COPSAC2010). Enrollment began March 2009 and included 623 women recruited at 24 weeks of pregnancy and 588 of their children. A dental examination was completed at age 6 years in 496 of 588 children (84%). Data were analyzed in 2018. Intervention:High-dose vitamin D3 (2400 IU/d; N?=?315) or matching placebo tablets (N?=?308) from pregnancy week 24 to 1 week post partum. In addition, all women received 400 IU/d of vitamin D3 as part of standard care. Main Outcomes and Measures:Enamel defect was defined as having at least 1 molar affected by demarcated opacity, enamel breakdown, and/or atypical restoration. Caries was defined as decayed, missing, or filled surfaces in both the deciduous and permanent dentitions (World Health Organization standard). Results:The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n?=?26 of 172] vs 27.5% [n?=?44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81). A similar association was observed for the deciduous dentition (8.6% [n?=?21 of 244] vs 15.9% [n?=?40 of 252]; odds ratio, 0.50; 95% CI, 0.28-0.87). There was no association between supplementation and caries. Conclusions and Relevance:High-dose vitamin D supplementation during pregnancy was associated with approximately 50% reduced odds of enamel defects in the offspring. This suggests prenatal vitamin D supplementation as a preventive intervention for enamel defects, with a clinically important association with dental health. Trial Registration:ClinicalTrials.gov identifier: NCT00856947.

Dataset Information

Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis.

Publications

Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis.

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