Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes

NCT07810244 | Not Yet Recruiting

• 1 other identifier: 7022/NID
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Odontogenic Infection; Maxillofacial Infection; Cellulitis; Cellulitis of Face; Abscess

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group A

ACTIVE COMPARATOR

Clindamycin 300 mg oral capsule, four times daily.

Drug: Clindamycin

group B

ACTIVE COMPARATOR

Moxifloxacin 400 mg oral tablet, once daily.

Drug: Moxifloxacin (400 mg)

Interventions

Clindamycin DRUG

Clindamycin 300 mg oral capsule, four times daily.

group A

Moxifloxacin (400 mg) DRUG

Moxifloxacin 400 mg oral tablet, once daily.

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Institute of Dentistry Multan

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cellulitis; Abscess

Interventions

Clindamycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Zeeshan Aslam, FCPS R(OMFS)

CONTACT

+923238632670; zaslam861@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Zeeshan Aslam

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)