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临床试验/NCT06893523
NCT06893523已完成不适用

Evaluation of the Effect of Concentrated Growth Factor (CGF) on Postoperative Edema in Bilateral Impacted Third Molar Surgery: A Randomized Controlled Clinical Study

Ege University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2017年5月1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
49
试验地点
1
主要终点
Postoperative edema amounts on CGF-applied and CGF free sides in bilateral impacted third molar surgery

研究概览

简要总结

The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on edema after bilateral impacted third molar surgery and to determine its contribution to the healing process.

The main question it aims to answer is:

Is CGF effective on reducing the edema in impacted third molar surgery? Researchers compare the edema amount on the CGF-applied and CGF free sides after impacted third molar surgery. The edema measurements are performed on the second and seventh days.

详细描述

It has been observed that the treatment of impacted tooth extraction, which is the most commonly performed interventional procedure in oral and maxillofacial surgery clinics and affects the patient's comfort and daily life after the operation, has been investigated in many ways and new ideas are constantly emerging. Wound healing is a process controlled by many intracellular and extracellular mechanisms. In recent years, many studies have been conducted to make this process faster and more successful, and it has been observed that the use of platelet products in this area has yielded extremely successful results. Concentrated Growth Factor (CGF), which has gained an important place in regenerative medicine in recent years, has attracted attention due to its potential to minimize postoperative complications.

This randomized clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University.

Forty-nine patients, regardless of gender, with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted third molar in the mandible and without any systemic disease are included in the study. Before the impacted third molar surgery, detailed medical and dental history are taken from the patients.

The patients are informed in detail about the drugs to be used in the study, the applied method, the duration and purpose of the study.

In order to obtain the data required for statistical analysis of the amount of edema on the sides where CGF is used and not used after the operation, edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation.

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
Single (Participant)

入排标准

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

入选标准

  • •Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
  • •Patients without any systemic disease
  • •Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.-

排除标准

  • •Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
  • •Having a systemic viral, fungal or bacterial infection
  • •Patients with acute or chronic maxillary sinusitis
  • •Suspected or diagnosed pregnancy and nursing mothers
  • •Patients with heart and vascular diseases
  • •Patients with liver disease, haematological disease and neoplastic disease
  • •Patients who have recently received anti-inflammatory therapy
  • •Patients with chronic medication use (antihistamines, NSAIDs, steroids and antidepressants)
  • •Patients predisposed to psychotic or psychopathic tendencies
  • •Patients with rheumatic diseases, blood diseases, diabetes mellitus
  • •Patients at cardiological risk of infective endocarditis
  • •Patients under antibiotic pressure

研究组 & 干预措施

CGF

Experimental

Participants received CGF after the operation on one side

干预措施: Concentrated Growth Factor (Other)

CGF

Experimental

Participants received CGF after the operation on one side

干预措施: Non-CGF (Other)

non-CGF

No Intervention

The other extraction socket is left empty

结局指标

主要结局

Postoperative edema amounts on CGF-applied and CGF free sides in bilateral impacted third molar surgery

时间窗: Before operation to the end of the operation at seven days

Edema measurements are made at three points on the patients before the operation, on the 2nd and 7th days after the operation. These measurements are made between the external canthus-angulus mandible, tragus-commissura and tragus-pogonium. In order to ensure standardization, all measurements are made by the same physician with the patient's head position in the same direction.

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

Mert Zeytinoğlu

Assoc. Prof. Dr.

Ege University

研究点 (1)

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