Odontogenic InfectionNCT07810244
Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes
A study testing Clindamycin and Moxifloxacin (400 mg) in people with Odontogenic Infection and Maxillofacial Infection, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
Investigators 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Odontogenic Infection, Maxillofacial Infection, Cellulitis
- What is being tested?
- Clindamycin and Moxifloxacin (400 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to 15 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Nishtar Institute of Dentistry Multan
Multan, Punjab Province, 60000
Dr. Sohail Fareed, FCPS (OMFS), +923017430431, dr_sohail_nmc@hotmail.com
Zeeshan Aslam, FCPS Resident (OMFS)
About this study
Official title: Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes: A Preliminary, Intrahospital, Controlled Clinical Trial
Investigators 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, participants are randomly assigned to take either moxifloxacin (400 mg once daily) or clindamycin (300 mg four times daily) for 5 to 7 days.
Investigators primary focus is early pain relief. Investigators will measure the drop in pain scores using a 100 mm visual scale at the day 2-3 follow-up visit. Investigators 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 participants respond to both drugs.
- Being tested
- Clindamycin, Moxifloxacin (400 mg)
- Medical subject headings
- Cellulitis, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Clindamycin 300 mg oral capsule, four times daily.
Moxifloxacin (400 mg)Drug
Moxifloxacin 400 mg oral tablet, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin | Active comparator | Clindamycin 300 mg oral capsule, four times daily. Receives: Drug: Clindamycin |
| Moxifloxacin | Active comparator | Moxifloxacin 400 mg oral tablet, once daily. Receives: Drug: Moxifloxacin (400 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-7 days
pain intensity
To compare the mean percentage reduction in pain intensity measure by Visual Analogue Scale 0 to 100 at day 2-3 from baseline between patients treated with moxifloxacin and patients treated with clindamycin. 0 reading means better outcome while 100 means worse outcome
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontogenic InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Aslam, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810244
- Sponsor's protocol ID
- 7022/NID
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.