Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abscess; Cellulitis; Odontogenic Infection; Maxillofacial Infection; Cellulitis of Face
• Intervention / Treatment: Drug: Clindamycin; Drug: Moxifloxacin (400 mg)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeeshan Aslam, FCPS R(OMFS); Phone Number: +923238632670; Email: zaslam861@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • Nishtar Institute of Dentistry Multan
      • Contact: Dr. Sohail Fareed, FCPS (OMFS); Phone Number: +923017430431; Email: dr_sohail_nmc@hotmail.com
      • Principal Investigator: Zeeshan Aslam, FCPS Resident (OMFS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; Clindamycin 300 mg oral capsule, four times daily.	Drug: Clindamycin; Clindamycin 300 mg oral capsule, four times daily.
Active Comparator: group B; Moxifloxacin 400 mg oral tablet, once daily.	Drug: Moxifloxacin (400 mg); Moxifloxacin 400 mg oral tablet, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical cure rate	To compare the clinical cure rate (complete resolution of signs and symptoms) at the end of treatment (day 5-7) between the two groups.	5-7 days
pain intensity	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.	2-3 days

Collaborators and Investigators

• Sponsor: Nishtar Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: September 3, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Infections; Inflammation; Skin Diseases, Infectious; Suppuration; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Abscess; Cellulitis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Glycosides; Pyrrolidines; Lincomycin; Lincosamides; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin; Clindamycin
• Other Study ID Numbers: 7022/NID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No