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临床试验/NCT07753044
NCT07753044已完成不适用

Effect of Photoactivated Disinfection Versus Laser Disinfection of Infected Sockets on the Success of Immediate Implant Placement (a Randomized Controlled Clinical Trial)

Alexandria University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2025年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
implant stability

研究概览

简要总结

Background: Dental implantology offers reliable tooth replacement options, but infections in extraction sockets can compromise osseointegration. Conventional disinfection methods, such as chlorhexidine, often fail to completely eliminate pathogenic microorganisms and may impair tissue healing. Photoactivated disinfection (PAD) and laser disinfection have emerged as promising alternatives. PAD employs a light-activated photosensitizer to generate reactive oxygen species (ROS), effectively disrupting bacterial membranes while preserving host cell viability. In parallel, laser disinfection utilizes focused light energy to eliminate bacterial biofilms and contaminated tissue with minimal thermal damage. In this study, we specifically utilize the Er,Cr:YSGG laser, which operates at a water-absorbing wavelength to induce micro-explosions that mechanically disrupt biofilms and promote a cleaner socket environment for improved osseointegration. Aim of the study: To compare the effectiveness of photoactivated disinfection (PAD), Er,Cr:YSGG laser disinfection, and conventional disinfection with chlorhexidine in decontaminating infected extraction sockets prior to immediate implant placement, promoting bone healing, and improving the osseointegration and stability of immediate implants placed in infected extraction sockets.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having posterior tooth/teeth indicated for extraction
  • Patients must exhibit radiographic evidence of infection, defined as chronic periapical pathology (radiolucency)
  • The extraction site should have intact surrounding alveolar bone
  • There must be at least 2 mm of sound bone beyond the root apex
  • Patients must be in overall good health and free from uncontrolled systemic conditions

排除标准

  • History of radiation therapy in the head and neck region
  • Pregnant or lactating women
  • Patients on long-term antibiotic therapy, as it could influence the outcomes
  • Heavy Smoking: More than 10-15 cigarettes per day.
  • Significant bruxism or parafunctional habits affecting implant stability.

研究组 & 干预措施

PAD

Experimental

干预措施: Photoactivated disinfection (Other)

Er,Cr:YSGG laser Group

Experimental

干预措施: Er,Cr:YSGG laser disinfection (Other)

Conventional group

Active Comparator

干预措施: Chlorohexidine disinfection (Other)

结局指标

主要结局

implant stability

时间窗: 6 months

Resonance Frequency Analysis (RFA) using Osstell ISQ: Implant Stability Quotient (ISQ) values will be recorded at 6 months after implant placement. Values from 1 to 100, the higher the ISQ, the higher the stability of the implant.

change in bone density

时间窗: baseline and 6 months

Bone density assessment using radiographs immediately post-operative and at 6 months.

change in marginal bone loss

时间窗: baseline and 6 months

Marginal Bone Loss (MBL) assessment using radiographs immediately postoperative and at 6 months.

次要结局

  • change in pain scores(up to 7 days)
  • change in post-operative edema(up to 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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