Odontogenic Infection, Maxillofacial Infection, Cellulitis, Cellulitis of Face, Abscess
Conditions
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.
Interventions
DRUGClindamycin
Clindamycin 300 mg oral capsule, four times daily.
Moxifloxacin 400 mg oral tablet, once daily.
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical cure rate | 5-7 days | To compare the clinical cure rate (complete resolution of signs and symptoms) at the end of treatment (day 5-7) between the two groups. |
| pain intensity | 2-3 days | 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. |
Countries
Pakistan
Contacts
CONTACTZeeshan Aslam, FCPS R(OMFS)
Outcome results
None listed