跳至主要内容
临床试验/NCT05137821
NCT05137821已完成不适用

Efficacy of Er: YSGG Laser on Oral Biofilm Removal From Implant Surface and Its Biological Response to Periodontal Tissues in Treatment of Peri-implantitis (An Ex Vivo Study)

Ain Shams University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop

研究概览

简要总结

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.

To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

详细描述

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.

To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants.

Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.

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 (Investigator)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: female or male.
  • Age: 25 - 55 years.
  • Medically controlled according to medical coding of review of systems (ROS)

排除标准

  • Tobacco smoking for at least 6 months before the study enrollment
  • Participants with ill-fitting restorations in both upper first molars that affect the stability of the stent.
  • Participants not following oral hygiene instructions.
  • Participants on dental treatment during the study period.
  • Participants with a history of drug administration
  • Vulnerable group.
  • Participants with long-term mouthwash administration.

结局指标

主要结局

visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop

时间窗: 2 weeks

evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology

次要结局

  • Profilometer analysis of surface roughness changes(1 month)

研究者

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

alaa

Assistant lecturer of oral medicine and periodontology

Ain Shams University

研究点 (2)

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