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临床试验/NCT07841301
NCT07841301已完成不适用

Comparative Evaluation of the Regenerative Potential of Platelet- Rich Fibrin (PRF) and Emdogain® in the Surgical Treatment of Class II Furcation Defects of Mandibular Molars

Medical University of Sofia1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年12月2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
发起方
入组人数
21
试验地点
1
主要终点
Change in Horizontal Furcation Probing Depth

研究概览

简要总结

This study evaluated the regenerative potential of platelet-rich fibrin (PRF) compared with enamel matrix derivative (Emdogain®) in the surgical treatment of Class II (F2) furcation defects of mandibular molars. Twenty-one systemically healthy patients with a total of 30 mandibular molars presenting with buccal Class II furcation defects were included. The furcation defects were treated surgically with either PRF or Emdogain®. Clinical parameters, including periodontal probing depth, clinical attachment level, bleeding on probing, and furcation involvement, were assessed before treatment and during follow-up. Clinical and radiographic measurements of the furcation defects were also performed. The main follow-up evaluation was conducted 6 months after surgery. The study compared the clinical and radiographic outcomes of PRF and Emdogain® in the treatment of mandibular molars with Class II furcation defects.

研究设计

研究类型
Interventional
分配方式
Non 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
否

入选标准

  • •Systemically healthy individuals
  • •Stage III or Stage IV periodontitis
  • •without allergies.

排除标准

  • •Inadequate plaque control
  • •Systemic diseases that may compromise periodontal therapy, including diabetes, immunodeficiency, or viral diseases.
  • •Immunosuppressive therapy.
  • •Treatment with bisphosphonates.
  • •Treatment with anticoagulants.
  • •Treatment with antiplatelet agents.
  • •Thrombocytopenia.
  • •Hypofibrinogenemia.
  • •Hemophilia.
  • •Other coagulation disorders.
  • •Pregnancy.
  • •Breastfeeding.

研究组 & 干预措施

PRF

Experimental

Surgical treatment of a mandibular molar with a Class II (F2) furcation defect using platelet-rich fibrin (PRF) following surgical debridement and root surface instrumentation.

干预措施: Platelet rich fibrin (Biological)

Emdogain

Active Comparator

Surgical treatment of a mandibular molar with a Class II (F2) furcation defect using enamel matrix derivative (Emdogain®) following surgical debridement and conditioning of the root surface with PrefGel®.

干预措施: Emdogain (Biological)

结局指标

主要结局

Change in Horizontal Furcation Probing Depth

时间窗: Baseline to 6 months after surgery

Change in the horizontal probing depth of the furcation defect, measured at the furcation entrance before surgery and 6 months after surgery. The measurement was used to assess the horizontal component of furcation involvement and the clinical response to treatment.

次要结局

  • Change in Probing Pocket Depth(Baseline to 6 months after surgery)
  • Change in Clinical Attachment Level(Baseline to 6 months after surgery)
  • Change in Vertical Bone Loss(Baseline to 6 months after surgery)
  • Change in Horizontal Bone Loss.(Baseline to 6 months after surgery)

研究者

发起方
Medical University of Sofia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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