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临床试验/NCT02907528
NCT02907528已完成不适用

Furcation Therapy With Enamel Matrix Derivative: Effects on the Subgingival Microbiome

Ohio State University0 个研究点目标入组 39 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
主要终点
Shifts in the subgingival microbiome at 3 and 6 months in response to the interventions

研究概览

简要总结

Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD + βTCP/HA) and EMD alone.

Material and Methods: 39 patients, presenting at least one mandibular class II furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling; βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD + EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis were evaluated at baseline, 6 and 12 months.

详细描述

Although enamel matrix derivative (EMD) has been used to promote periodontal regeneration, little is known of its effect on the microbiome. Therefore, this investigation aimed to identify the changes in periodontal microbiome following treatment with EMD using a deep-sequencing approach. Thirty-nine patients having mandibular class II buccal furcation defects were randomized to beta-tricalcium-phosphate/hydroxyapatite graft (BONE group), EMD+BONE or EMD alone. Plaque was collected from furcation defects at baseline, 3 and 6 months post-treatment. Bacterial DNA was analyzed using terminal restriction fragment length polymorphism (t-RFLP) and 16S pyrotag sequencing. 169,000 classifiable sequences were compared to HOMD using the QIIME and PhyloToAST pipelines. Statistical comparisons were made using parametric tests. At baseline, a total of 422 species were identified from the 39 defects, belonging to Fusobacterium, Pseudomonas, Streptococcus, Filifactor and Parvimonas. All three regenerative procedures predictably altered the disease-associated microbiome, with a restitution of health-compatible species. However, EMD and BONE+EMD groups demonstrated more long-term reductions in higher number of species than in BONE group (p<0.05), especially disease-associated species e.g. Selenomonas noxia, F.alocis, and Fusobacterium. EMD may promote periodontal regeneration by predictably altering a dysbiotic subgingival microbiome, decreasing pathogen richness and increasing commensal abundance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Untreated ChronicPeriodontitis

排除标准

  • Diabetes Pregnancy Current Smoking

结局指标

主要结局

Shifts in the subgingival microbiome at 3 and 6 months in response to the interventions

时间窗: 6 months

Subgingival microbial plaque samples will be collected at baseline and at the 3 and 6-month re-evaluation visits. Bacterial samples will be removed from the paper points by adding 200µl of phosphate buffered saline (PBS) and vortexing for 1 minute. The paper points were then removed, and DNA isolated using a Qiagen MiniAmp kit (Valencia, CA) according to the manufacturer's instructions. Multiplexed bacterial tag-encoded FLX amplicon pyrosequencing will be performed using the Titanium platform. High quality, classifiable sequences (quality score \>25, \>200bp length) were clustered into species-level operational taxonomic units (s-OTUs) at 97% sequence similarity and assigned a taxonomic identity by alignment to the HOMD database using the Blastn algorithm. Primary outcome measures will be changes in diversity, equitability and levels of pathogens.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Purnima Kumar

Associate Professor

Ohio State University

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