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临床试验/NCT07261878
NCT07261878进行中(未招募)不适用

Injectable Platelet Rich Fibrin (I-PRF) With Xenograft in Intrabony Defects of Periodontitis Patient Stage III Versus Xenograft Alone

Al-Azhar University4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
4
主要终点
Radiographic parameters

研究概览

简要总结

Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone.

详细描述

All surgical procedures will be conducted by a single operator. Following administration of local anesthesia, intrasulcular incisions will beperformed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded. In the group1: xenograft alone(Bovin xenograft)will be applied to the intrabony defect area. In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. Preperation of Injectable platelate Rich Fibrin (I-PRF) : will be prepared for each patient as follows: 5 ml of venous blood will be collected from the patient blood then placed in a plastic tube without any added material or coagulant and centrifuged at 700 rpm for 3 min. then mixed with Xenograft. Finally, the flap will be passively repositioned using interrupted 4-0 silk

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
None

入排标准

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

入选标准

  • Patient should have localized Periodontitis stage III grade B with pocket depth ≥ 6mm; indicated for periodontal surgery
  • Patient's agreement to the surgical procedure and clinical trial.
  • Age ranged between 30-55 years old.
  • Intrabony defects with depth ≥3mm.
  • Free from any systemic conditions and no previous drug affect bone metabolism

排除标准

  • Pregnant women.
  • Patients in variation in anatomical landmarks.
  • Patients with psychological problems.
  • Patients with abnormal habits.

结局指标

主要结局

Radiographic parameters

时间窗: 6 months after treatment

• The bone fill after 6 months postoperatively using digital periapical radiography using parallel technique.

次要结局

  • Clinical attachment level (CAL)(pre-surgically 3 months and 6 months respectively)
  • Gingival index (GI)(pre-surgically 3 months and 6 months respectively)
  • Pocket depth (PD)(presurgically, 3 and 6 months interval after treatment)
  • Plaque index (PI)(pre-surgically 3 months and 6 months respectively)
  • Gingival index (GI)(pre-surgically 3 months and 6 months respectively)
  • Clinical attachment level (CAL)(pre-surgically 3 months and 6 months respectively)

研究者

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

Ola Alsareh

Oral Medicine, Periodontology, Oral Diagnosis and Radiology Department Faculty of Dental Medicine for Girls Al-Azhar University

Al-Azhar University

研究点 (4)

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