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临床试验/NCT05211362
NCT05211362Unknown4 期

Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年4月16日最近更新:
适应症

试验速览

阶段
4 期
入组人数
32
试验地点
2
主要终点
change in clinical attachment level

研究概览

简要总结

One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No systemic diseases which could influence the outcome of therapy.
  • Good compliance with plaque control instructions following initial therapy.
  • Teeth involved were all vital with no mobility.
  • Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
  • Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
  • Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
  • Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.

排除标准

  • Pregnant females.

结局指标

主要结局

change in clinical attachment level

时间窗: baseline, 3, and 6 months

change in clinical attachment level

次要结局

  • change in interseptal bone width(baseline, 3, and 6 months)

研究者

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

mahmoud eldestawy

associate professor

Al-Azhar University

研究点 (2)

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