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临床试验/NCT03494972
NCT03494972已完成不适用

A Tetracycline Drain Reduces Alveolar Osteitis in Third Molar Surgery

University of Oslo1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Alveolar ostitis

研究概览

简要总结

The aim of this study was to investigate the effect of an oxytetracycline impregnated gauze drain on the incidence of alveolar osteitis (AO) and postoperative pain during the first week after mandibular third molar surgery.

详细描述

The study was designed as a single-blinded randomized controlled trial. Patients were randomized in two groups by a sealed envelope system: a drain group and a control group. The study population comprised patients undergoing surgical removal of one or both mandibular third molars (3M) during January 2016 until March 2017. Patients referred to our department, who fulfilled the inclusion criteria, were asked to participate in the study. Patients were prospectively included after giving written informed consent.

The inclusion criteria were: age >18 years, indication for removal of one or both 3M, ASA I-II, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "Data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week. Exclusion criteria were: age <18 years, no indication for removal of 3M, ASA III or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week. The National Institutes of Health's Consensus Statement (1979) and the American Association of Oral and Maxillofacial Surgeons White Paper on Third Molar Data (2007) served as guidelines when evaluating indication for 3M removal (NIH Consensus Statement 1979, AAOMS White Paper 2007).

Study population (n=200) and group size (n=100) were determined through power analysis: 90% power, 5% significance level and an expected difference of up to 10% between the two groups.

研究设计

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

入排标准

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

入选标准

  • The inclusion criteria were: age >18 years, indication for removal of one or both 3M, ASA I-II, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "Data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week.

排除标准

  • Exclusion criteria were: age <18 years, no indication for removal of 3M, ASA III or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week.

研究组 & 干预措施

drain

Active Comparator

Tetracyclin drain

干预措施: Tetracyclin ointment (Drug)

No-drain

Sham Comparator

No drain

干预措施: Tetracyclin ointment (Drug)

结局指标

主要结局

Alveolar ostitis

时间窗: One week

Registration of pain

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

Tore Bjornland

Professor

University of Oslo

研究点 (1)

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