下第三磨牙手术后的并发症
应用莫西沙星和头孢克肟减少下颌第三磨牙术后炎症后遗症及并发症的疗效
研究概览
地位
详细说明
临床研究在塞尔维亚诺维萨德伏伊伏丁那牙科诊所口腔外科进行,采用双盲前瞻性临床研究设计。 微生物学研究是在塞尔维亚诺维萨德伏伊伏丁那公共卫生研究所微生物学中心进行的,对从术后感染患者的手术伤口或从冠状周间隙获得的渗出液(脓液)获得的拭子样本进行了微生物学研究。冠周炎或有冠周炎病史的患者。 微生物学检测分离微生物对莫西沙星、头孢克肟等口腔颌面外科常用抗生素(青霉素及其衍生物、红霉素、阿奇霉素、克林霉素、四环素)的敏感性。 患者年龄≥18 岁,需要手术切除下颌阻生第三磨牙,全身健康状况良好 - 患者被归类为美国麻醉医师协会 (ASA) 的身体健康分类是手术患者术前健康状况的分级系统 - ASA I 和ASA II 被纳入研究。 根据术后后遗症或并发症对应用药物的效果进行评估。 术后评估了并发症,包括干槽症/牙槽骨炎 (AO) 和手术部位的术后感染 (SSI),以及炎症后遗症 - 疼痛、肿胀和牙关紧闭(张口受限)。
在冠周炎或有冠周炎病史的情况下,存在渗出物或脓液,以及在术后感染的情况下,从手术伤口或冠周间隙中取出拭子,将渗出液或脓液点状送出用于微生物分析。 该分析的主要目标是确定微生物不仅对本研究中使用的抗生素的敏感性,而且还确定微生物对抗生素(牙源性感染治疗的“金标准”)以及其他常用抗生素的敏感性。治疗。 通过标准细菌学技术(将材料播种在适当的营养培养基上并在 35-37°C 下孵育 18-24 小时)进行分析以分离细菌。 细菌种类的鉴定是通过经典细菌学方法(形态学、培养和生理生化)以及自动化系统矩阵辅助激光解吸电离 - 飞行时间(MALDI-TOF),德国进行的。 鉴定后,根据 Kirby-Bauer、Mueller-Hinton 琼脂和血液 Mueller-Hinton 琼脂(HiMedia,印度),通过标准纸片扩散法对分离的细菌物种对抗菌药物进行敏感性测试,具体取决于所讨论的细菌物种符合欧洲抗菌药物敏感性测试委员会 (EUCAST) 或临床与实验室标准协会 (CLSI) 指南。 来自法国 Bio-Rad 的圆盘用于进行微生物分析。
所有手术干预均在局部麻醉下进行,使用 2% 利多卡因与肾上腺素 1:80,000 共 4 ml 体积(2 ml 注射液含有 40 mg 盐酸利多卡因一水合物形式的盐酸利多卡因和 0.025 mg 肾上腺素形式的酒石酸肾上腺素:利多卡因 2% - 肾上腺素,40 mg +0.025。 在所有患者中,手术涉及三角形粘骨膜瓣设计,使用合成多丝非吸收性缝合材料缝合 (3-0)。 建议患者服用含有 200 毫克布洛芬和 325 毫克对乙酰氨基酚的止痛药。
根据已知的伦理原则和良好临床实践 (GCP) 的原则,根据赫尔辛基宣言的最新修订版和适用于人体临床试验。 本次临床试验的患者保护负责人为主要研究者,与诺维萨德大学伏伊伏丁那牙科诊所伦理委员会合作。 患者签署知情同意书,暗示患者已获悉本研究的全部信息,并强调患者有权独立决定是否参与,不受胁迫和外界影响,拒绝参与也不产生任何不良后果。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Vojvodina
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Novi Sad、Vojvodina、塞尔维亚、21000
- Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 年龄≥18 岁、需要手术切除下颌阻生第三磨牙、全身健康状况良好的患者(分类为 ASA I 和 ASA II 的患者)被纳入研究。
排除标准:
- 对研究药物过敏;随机分组前 6 个月内全身性抗菌治疗史;怀孕或哺乳;氟喹诺酮相关的肌腱疾病;临床相关的心脏病或 QT 间期延长药物;严重肝功能不全(Child-Pugh C)。 此外,不包括研究中患者的标准是,除了去除受影响的下颌第三磨牙外,还进行了一些其他口腔外科手术,以及目前患有冠周炎的患者。
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:有源比较器:第一个测试组
患者口服含 400 mg 莫西沙星的薄膜包衣片剂。
术后前五天以双盲方式给予薄膜包衣片剂,每天一次。
所有患者均在术后第一天、第二天和第七天进行术后随访。
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所有使用过的薄膜包衣片(400 mg 莫西沙星)在术后前五天给药,每天一次,在下第三磨牙手术后。
其他名称:
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有源比较器:有源比较器:第二个测试组
患者口服含 400 mg 头孢克肟的薄膜包衣片剂。
术后前五天以双盲方式给予薄膜包衣片剂,每天一次。
所有患者均在术后第一天、第二天和第七天进行术后随访。
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所有使用过的薄膜包衣片(400 mg 头孢克肟)在术后前五天给药,每天一次,在下第三磨牙手术后。
其他名称:
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安慰剂比较:安慰剂对照:对照组
三分之一的患者接受含有无抗菌作用的无关物质的安慰剂片剂(99% 微晶纤维素、0.5% 二氧化硅和 0.5% 硬脂酸镁,其颜色和整体外观与所用抗生素相同。
术后前五天以双盲方式给予薄膜包衣片剂,每天一次。
所有患者均在术后第一天、第二天和第七天进行术后随访。
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所有使用过的薄膜包衣安慰剂片剂均在下颌第三磨牙手术后的前五天给药,每天一次。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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手术部位术后感染率 (SSI)
大体时间:手术后最多 12 周(3 个月)。
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根据局部炎症迹象和一般中毒迹象(体温升高、红细胞沉降加速、白细胞增多、C-反应蛋白水平等)的存在,在临床上记录术后感染迹象。
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手术后最多 12 周(3 个月)。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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干槽症(牙槽骨炎)
大体时间:通过7天。
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干槽症(牙槽骨炎)的诊断依据是报告的伤口区域剧烈疼痛,并伴有手术伤口的特定局部临床表现和无脓液。
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通过7天。
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通过视觉模拟量表 (VAS) 评估术后疼痛
大体时间:术后第1、2、7天。
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使用视觉模拟量表 (VAS) 评估术后疼痛。
VAS 表示水平绘制的 100 毫米长度,开始表示左侧无痛状态,右侧结束表示可以想象的最强烈疼痛状态。
所有患者都通过在量表上划破折号来表示他们在术后期间的适当日子感受到的最强烈的疼痛强度。
疼痛强度通过测量标尺上标记位置与左侧标尺起点的距离来确定,并以毫米表示。
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术后第1、2、7天。
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术后肿胀(水肿)
大体时间:术后第1、2、7天。
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通过测量以毫米为单位的特定参考点之间的术前和术后距离,获得术后肿胀(水肿)系数。
参考点是:外眼角和下颌角;唇角和耳屏;和下巴尖和耳屏。
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术后第1、2、7天。
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术后牙关紧闭(切牙间最大张口度)
大体时间:术后第1、2、7天。
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通过测量最大张口能力时上下中切牙近中切牙角之间的距离来评估术后牙关紧闭的程度。
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术后第1、2、7天。
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通过口头评定量表 (VRS) 评估术后疼痛
大体时间:术后第 1 至 7 天。
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使用口头评定量表 (VRS) 评估术后疼痛。
VRS 涉及基于六度 (1-6) 的疼痛强度数值评估 - 无痛、几乎不敏感的疼痛、轻度疼痛、中度疼痛、剧烈疼痛和非常强烈、几乎无法忍受的疼痛。
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术后第 1 至 7 天。
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通过镇痛药的数量评估术后疼痛
大体时间:术后第 1 至 7 天。
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在每个患者中,记录术后疼痛的时刻,其在指定观察时间的强度,并记录是否需要额外的镇痛药(患者在术后疼痛监测中记录从完成手术干预到拆线每天消耗的镇痛药数量协议)。
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术后第 1 至 7 天。
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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体外分离微生物的抗生素敏感性和抗性率(微生物学评估)。
大体时间:手术后最多 12 周(3 个月)。
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分离微生物对口腔颌面外科常用的莫西沙星、头孢克肟和其他抗生素的敏感性进行了微生物学测试。
关于细菌对抗菌药物的敏感性,根据生长抑菌圈将细菌分为敏感(S)、中间(I)和耐药(R)三类。
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手术后最多 12 周(3 个月)。
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临床试验中药物不良事件 (ADE) 的发生率
大体时间:手术后最多 24 天。
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在研究期间,将根据 GCP 记录临床研究中使用的药物的任何不良事件。
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手术后最多 24 天。
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合作者和调查者
调查人员
- 学习椅:Branislav V Bajkin, MD, DMD, PhD、Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
- 研究主任:Branimir D Stošić, DMD, PhD、University of Novi Sad, Faculty of Medicine
出版物和有用的链接
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