Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes
2026年9月3日 更新者：Zeeshan Aslam、Nishtar Medical University
Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes: A Preliminary, Intrahospital, Controlled Clinical Trial
We are conducting a trial to compare moxifloxacin against clindamycin for dental infections that spread to the face and jaw. The study will enroll 60 adults who are being treated as outpatients for localized abscesses or cellulitis. Every patient will first receive minor surgical drainage in the clinic. Following drainage, they are randomly assigned to take either moxifloxacin (400 mg once daily) or clindamycin (300 mg four times daily) for 5 to 7 days.
Our primary focus is early pain relief. We will measure the drop in pain scores using a 100 mm visual scale at the day 2-3 follow-up visit. We also plan to track how many patients are fully cured by day 5-7, monitor any side effects, and test the infection samples to see exactly which bacteria are present and how they respond to both drugs.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zeeshan Aslam, FCPS R(OMFS)
- 电话号码：+923238632670
- 邮箱：zaslam861@gmail.com
学习地点
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Punjab Province
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Multan、Punjab Province、巴基斯坦、60000
- Nishtar Institute of Dentistry Multan
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接触：
- Dr. Sohail Fareed, FCPS (OMFS)
- 电话号码：+923017430431
- 邮箱：dr_sohail_nmc@hotmail.com
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首席研究员：
- Zeeshan Aslam, FCPS Resident (OMFS)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients aged 18 years and above of either gender presenting to the Outpatient Department of the Nishtar Institute of Dentistry, Department of Maxillofacial Surgery.
- Clinical and radiographic diagnosis of an odontogenic maxillofacial infection - gingival inflammatory infiltrate or a localized abscess/cellulitis (ICD-10: K04, K05) - manageable on an outpatient basis with minor office-based surgical drainage (incision/drainage, extraction, or trepanation under local anaesthesia) and adjunctive oral antibiotic therapy, not requiring hospital admission.
- Patients providing written informed consent for participation.
Exclusion Criteria:
- Known hypersensitivity to fluoroquinolones, lincosamides, or cephalosporins.
- Pregnant or lactating women.
- Patients with diabetes mellitus, known HIV infection, hepatic dysfunction, or renal impairment (creatinine clearance < 50 mL/min).
- Patients with known cardiac arrhythmia, bradycardia, electrolyte imbalance (particularly hypokalaemia), or a history of tendinopathy related to quinolone use.
- Patients with signs of a severe or spreading systemic infection (e.g., extensive facial/neck swelling, trismus, dysphagia, or high-grade fever) requiring hospital admission, intravenous antibiotics, or extraoral surgical drainage under general anaesthesia.
- Patients who received systemic antibiotic therapy within the preceding 7 days.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：group A
Clindamycin 300 mg oral capsule, four times daily.
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Clindamycin 300 mg oral capsule, four times daily.
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有源比较器：group B
Moxifloxacin 400 mg oral tablet, once daily.
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Moxifloxacin 400 mg oral tablet, once daily.
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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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clinical cure rate
大体时间：5-7 days
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To compare the clinical cure rate (complete resolution of signs and symptoms) at the end of treatment (day 5-7) between the two groups.
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5-7 days
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pain intensity
大体时间：2-3 days
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To compare the mean percentage reduction in pain intensity (VAS) at day 2-3 from baseline between patients treated with moxifloxacin and patients treated with clindamycin.
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2-3 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 1. Cachovan G, Böger RH, Giersdorf I, Hallier O, Streichert T, Haddad M, et al. Comparative efficacy and safety of moxifloxacin and clindamycin in the treatment of odontogenic abscesses and inflammatory infiltrates: a phase II, double-blind, randomized trial. Antimicrob Agents Chemother. 2011;55(3):1142-7. 2. Gómez-Arámbula H, Hidalgo-Hurtado A, Rodríguez-Flores R, González-Amaro AM, Garrocho-Rangel A, Pozos-Guillén A. Moxifloxacin versus Clindamycin/Ceftriaxone in the management of odontogenic maxillofacial infectious processes: a preliminary, intrahospital, controlled clinical trial. J Clin Exp Dent. 2015;7(5):e634-9. 3. Ardila CM, Bedoya-García JA. Antimicrobial resistance in patients with odontogenic infections: a systematic scoping review of prospective and experimental studies. J Clin Exp Dent. 2022;14(10):e870-6. 4. Grillo R, Borba AM, Brozoski M, Moreira SB, da Silva YS, da Graça Naclério-Homem M. Evolution of the treatment of severe odontogenic infections over 50 years: a comprehensive review. J Taibah Univ Med Sci. 2022;18(2):225-33. 5. Fischer M, Rödel J, Schultze-Mosgau S, Tolksdorf K. Clinical impact of antibiotic resistance in odontogenic infections: a 12-year analysis of 740 cases. Clin Oral Investig. 2025;29:1-12. 6. Antibiotic resistance in odontogenic infections: a systematic review of current evidence and implications for guideline-based therapy. Clin Oral Investig. 2025. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC13095914/ 7. Antimicrobial therapy in the management of odontogenic infections: the penicillin-allergic patient. J Craniomaxillofac Surg. 2023.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年1月30日
研究完成 (估计的)
2027年2月15日
研究注册日期
首次提交
2026年9月3日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.