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Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes

ConditionsOdontogenic InfectionMaxillofacial InfectionCellulitisCellulitis of FaceAbscess
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNishtar Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clindamycin

    Drug

    Clindamycin 300 mg oral capsule, four times daily.

  • Moxifloxacin (400 mg)

    Drug

    Moxifloxacin 400 mg oral tablet, once daily.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: group AActive comparator 1 intervention
Group B: group BActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nishtar Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: