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临床试验/NCT06328413
NCT06328413已完成不适用

Comparative Evaluation of Pain, Soft Tissue Healing and Density of Newly Formed Bone Tissue in Surgical Extraction Sockets After Leukocyte and Platelet Rich Fibrin and Photobiomodulation Applications

Akdeniz University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2020年4月20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
入组人数
34
试验地点
2
主要终点
Newly formed bone (Healing at extraction sockets)

研究概览

简要总结

The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.

详细描述

After sample size calculation, healthy volunteers were included in the study. Both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. Photobiomodulation (PBM) or leukocyte and platelet rich fibrin (L-PRF), an autogenous blood product, was randomly applied to the right or left side extraction sockets. Volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the PBM treated side. Follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Class-I healthy volunteers
  • Between 18 and 40 years of age who had wisdom teeth (Pell and Gregory Class II, Position B) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth,
  • Not use steroids or anti-inflammatory drugs in the last 3 months.

排除标准

  • Patients with pericoronitis,
  • Smoking habits
  • Active periodontal disease
  • Pregnancy,
  • Breastfeeding
  • Unable to give personal consent, and those with missing physical examination and follow-up records were excluded.

研究组 & 干预措施

Photobiomodulation group

Experimental

Photobiomodulation application at different extra and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar

干预措施: photobiomodulation (Device)

Leukocyte and platelet-rich fibrin group

Active Comparator

Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session.

干预措施: Leukocyte and Platelet Rich Fibrin (Other)

结局指标

主要结局

Newly formed bone (Healing at extraction sockets)

时间窗: Bone healing at the end of 1st and 3rd months after third molar extractions

Newly formed bone assessed on Panoramic x-ray with Image J programme

次要结局

  • Soft tissue healing(End of 1st, 2nd week and 1st month after tooth extraction)
  • Probing depth(End of 1st, 2nd week and 1st month after tooth extraction)

研究者

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

Cennet Neslihan Eroglu,DDS,PhD

Assoc Prof Dr

Akdeniz University

研究点 (2)

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