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临床试验/NCT04641533
NCT04641533已完成不适用

Effect of Dental Pulp Stem Cells and L-PRF Placed Into the Extraction Sockets of Impacted Mandibular Third Molars on the Periodontal Status of Adjacent Second Molars: a Split Mouth Randomised Controlled Clinical Trial

Baskent University2 个研究点 分布在 2 个国家目标入组 13 人开始时间: 2018年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Probing pocket Depth (PPD)

研究概览

简要总结

The purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars.

详细描述

Patients aged between 18 and 30 years, seeking for bilateral impacted LM3 extraction surgeries and meeting eligibility criteria were included to the study. At baseline right and left impacted third molars (LM3s) were randomly assigned to one of the treatment group (L-PRF and L-PRF + DPSC). Baseline and 6th month clinical and radiographic measurements were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The random allocation list was generated by a periodontist (EEA), a clinical staff enrolled patients according to their reference date. The first allocation on the list was assigned to the right mandibular molar for each patient by the oral surgeon (SÇ).

入排标准

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

入选标准

  • Patients aged between 18 and 30 years
  • Bilateral impacted LM3 extraction surgeries requirement

排除标准

  • Having clinical signs or symptoms of abscess or cellulitis formation
  • Having a history of radiotherapy
  • Having any systemic diseases interfering with wound healing and/or smokers
  • Patients who had been diagnosed as periodontitis
  • Patients who had LM2s with caries or restorations that have an unidentifiable cementoenamel junction

结局指标

主要结局

Probing pocket Depth (PPD)

时间窗: 6 months

Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.

Clinical attachment level (CAL)

时间窗: 6 months

Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm.

次要结局

  • Relative bone density (rBD)(6 months)
  • Assessment of analgesic usage(7 days)
  • Radiographic vertical distance(6 months)
  • Post-operative pain as assessed by visual analogue scale (VAS)(7 days)

研究者

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

Secil Cubuk

Assist Prof

Baskent University

研究点 (2)

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