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临床试验/NCT05177198
NCT05177198Unknown不适用

Clinical and Radiographic Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2022年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Clinical attachment level ( CAL)

研究概览

简要总结

Periodontal infections in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention. It is evident with the available data that PRF has antimicrobial activity against microbial pathogens. Clindamycin is an effective antibiotic against anaerobic bacteria and it achieves higher levels of antimicrobial activity than other antibiotics. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects.

详细描述

Many factors had to be taken into consideration while treating intrabony defects to achieve the concept of periodontal regeneration. PRF is a material that contains growth factors enmeshed in the fibrin network resulting in their sustained release over a period of time that can accelerate the wound healing process. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects. The purpose of combination between the PRF and Clindamycin is for establishing a simple and practical method that gives antimicrobial properties to PRF and to provide evidence of its effectiveness, and that this may provide additional advantage and reduces the need for systemic antibiotics in a variety of oral surgical procedures. Protection of the regenerating area should be provided through the specifically designed surgical approaches. These different surgical approaches developed over time include differences in terms of flap design and suturing technique. Therefore, successful wound healing was strongly influenced by preservation of the microvasculature of soft tissues as well as by revascularization rates. The Minimally Invasive Surgical Technique (MIST) was proposed by to draw the aspects of wound and blood clot stability and primary wound closure for blood-clot protection. These concepts were further strengthened with the Modified Minimally Invasive Surgical Technique M-MIST, that further incorporated the concept of space provision for the process of regeneration. For this, the effect of Clindamycin augmented PRF together with M-MIST on the clinical and radiographic outcomes in the treatment of periodontal intrabony defects need to be evaluated for clinical effectiveness

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient-related criteria:
  • Patient consulting in the outpatient clinic.
  • Able to tolerate surgical periodontal procedures.
  • Patient ready to perform oral hygiene instructions.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the 12 months follow-up period.
  • Teeth related criteria:
  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.

排除标准

  • Patient-related criteria:
  • Medically compromised patients.
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Teeth related criteria:
  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade II or III mobility.
  • Teeth with proximal carious defects or proximal faulty restorations.

结局指标

主要结局

Clinical attachment level ( CAL)

时间窗: 9 months

Measured from the CEJ to the bottom of the gingival sulcus.

次要结局

  • Gingival index(9 months)
  • Radiographic linear defect depth(9 months)
  • Gingival recession(9 months)
  • Plaque index(9 months)
  • Radiographic defect bone density(9 months)
  • Probing Depth (PD)(9 months)

研究者

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

Sarah Yusri El-Sayed El-Ashry

Masters Student at Cairo University

Cairo University

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