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Not yet recruitingNCT07810244Updated Sep 9, 2026

Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes

An interventional study of Clindamycin and Moxifloxacin (400 mg) in Odontogenic Infection, Maxillofacial Infection and Cellulitis, sponsored by Nishtar Medical University. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Nishtar Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Odontogenic Infection
  • Maxillofacial Infection
  • Cellulitis
  • Cellulitis of Face
  • Abscess

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group A

    Clindamycin 300 mg oral capsule, four times daily.

    Drug: Clindamycin

  • Active comparator
    group B

    Moxifloxacin 400 mg oral tablet, once daily.

    Drug: Moxifloxacin (400 mg)

Interventions

  • DrugClindamycin

    Clindamycin 300 mg oral capsule, four times daily.

  • DrugMoxifloxacin (400 mg)

    Moxifloxacin 400 mg oral tablet, once daily.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5-7 days

  2. 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.

    Time frame: 2-3 days

06

Study locations

1 site
  • Nishtar Institute of Dentistry Multan
    Multan, Punjab Province 60000, Pakistan
    • Dr. Sohail Fareed, FCPS (OMFS) · Contact · dr_sohail_nmc@hotmail.com · +923017430431
    • Zeeshan Aslam, FCPS Resident (OMFS) · Principal investigator
07

References and documents

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.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07810244
Lead sponsor
Nishtar Medical University
Responsible party
Zeeshan Aslam (Doctor Zeeshan Aslam, Nishtar Medical University) — Principal investigator
First posted
Sep 9, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Zeeshan Aslam, FCPS R(OMFS)
Contact
zaslam861@gmail.com
+923238632670

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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