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临床试验/NCT04349579
NCT04349579进行中(未招募)4 期

Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine on Postoperative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
35
试验地点
1
主要终点
Postoperative Trismus

研究概览

简要总结

Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and mouthwashes are prescribed for the treatment of complications encountered. When using postoperative antibiotics in surgery of impacted third molar teeth, lower surgical area infection, pain, swelling and trismus are seen. Based on this information, in this study, it is aimed to evaluate the effects of rifamycine intraoperatively on the postoperative pain, swelling and trismus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • absence of any systemic disease
  • having bilateral impacted mandibular third molar teeth in a similar position
  • absence of allergy to any of the drugs used in the study,
  • absence of pregnancy/lactating state,
  • no history of any medication use during at least 2 week before the operation.

排除标准

  • not regularly coming to the controls,
  • not using their medicines regularly
  • using any additional medication that may affect the outcome of the study

研究组 & 干预措施

Rifamycine

Experimental

Rifamycine is a broad spectrum semi-synthetic antibiotic that acts on gram-positive and gram-negative microorganisms. As a local application, it has areas of use in dentistry such as washing fistula mouths, maxillary sinus and abscess wounds and treating osteomyelitis.

干预措施: Rifamycine (Drug)

Saline

Active Comparator

Saline, also known as saline solution, is a mixture of sodium chloride in water and has a number of uses in medicine. Applied to the affected area it is used to clean wounds. It is also used to dilute other drugs to be injected and to wash the operation site in dental surgery operations. It is most commonly used as a sterile 9 g of salt per litre (0.9%) solution, known as normal saline.

干预措施: Saline Solution (Drug)

结局指标

主要结局

Postoperative Trismus

时间窗: Postoperative 7th day

Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.

Postoperative Pain

时间窗: Postoperatif 7th day

Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).

Postoperative Swelling

时间窗: Postoperative 7th day

Postoperative swelling was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

levent Cigerim

Head of Oral and Maxillofacial Surgery Department

Yuzuncu Yıl University

研究点 (1)

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