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临床试验/NCT04415801
NCT04415801Unknown不适用

Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
change from baseline to 8 weeks of gingival fluid production

研究概览

简要总结

Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.

详细描述

Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used. Four months following implant placement [Baseline (BSL)], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns. Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1). Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant

排除标准

  • natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,

结局指标

主要结局

change from baseline to 8 weeks of gingival fluid production

时间窗: 8 weeks

The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renzo Guarnieri

Adjunct Professor

University of Roma La Sapienza

研究点 (2)

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