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临床试验/NCT04151147
NCT04151147已完成不适用

Effect of Concentrated Growth Factors on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Study

Ege University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年1月2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
70
试验地点
2
主要终点
Presence of alveolar osteitis formation

研究概览

简要总结

The aim of this prospective study was to assess the effectiveness of concentrated growth factors (CGFs) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars.

This study was designed as a randomized controlled clinical trial. In each case, one socket received CGFs and the other served as a control. The predictor variable was the CGFs application and the sides were categorized as 'CGFs' and 'non-CGFs'. The outcome variable was the development of AO during the first postoperative week. Also, demographic variable included age and gender was noted.

详细描述

The investigators designed and implemented a randomized single-blind clinical trial.Randomization was performed by simple coin toss to select the side of CGFs fibrin gel placement before the commencement of third molar surgery. In this way, the sides in each patient were randomly divided into 2 study groups:

Group I (test) - with CGFs placed in the extraction socket Group II (control) - without CGFs placement All operations were performed under local anesthesia by the same surgeon. An envelope flap was raised to provide access. Bone removal was done with the help of stainless steel burs. Constant irrigation with saline was used while removing bone to prevent thermal necrosis. Third molar was luxated with the help of straight elevator and then extracted with the help of third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. To prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. CGFs fibrin gel was then randomly placed into one socket and the opposite side was considered as the control. Finally, wound closure was completed with silk suture.

The primary outcome variable was AO, classified as present or absent.It is characterized by postoperative pain in and around the extraction side, which increases in severity within first week after the extraction, accompanied by a partially or totally disintegrated blood clot within the alveolar socket, with or without halitosis. Other defining symptoms that have been reported in the literature are radiating pain towards the temporal region and ear, inflamed gingival margin, ipsilateral regional lymphadenopathy and, less commonly, low-grade fever.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients Age ≥ 18 years of age
  • Willing and able to provide informed consent
  • Ability to cooperate with the requirements of the study protocol
  • Healthy patients without medical diseases or a history of bleeding problems
  • Patients with the need of extraction of third molars
  • The third molars had to be symmetrical, partially-erupted and in the Class I, Level B according to Pell & Gregory classification and in the vertical angulations according to Winter's classification.

排除标准

  • Patients who have pre-existing abscess or cellulitis, acute pericoronitis, or pre-existing conditions such as an odontogenic cyst or tumour associated with their third molars
  • Patients who were pregnant and breastfeeding
  • Patients with drug usage such as bisphosphonate, steroids and antidepressants
  • Patients who had a smoking habit

结局指标

主要结局

Presence of alveolar osteitis formation

时间窗: Change of alveolar osteitis formation at 7 days.

Clinical data was collected with regard to alveolar osteitis formation on the 3rd and 7th days after surgery with the following characteristics: 1) progressive and severe pain in and around the extraction side within first week; 2) partially or totally loss of blood clot and exposure of the alveolar bone with or without halitosis. Patients who met one of the criterias, were taken to be alveolar osteitis.

次要结局

未报告次要终点

研究者

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

Gözde Işık

Principal Investigator

Ege University

研究点 (2)

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