Odontogenic Infection Clinical Trial
Official title:
Randomized Controlled Trial Short Antibiotic Therapy (3-Day) Versus Long Antibiotic Therapy (7-Day) in Odontology-Stomatology: Impact on the Resistance of Oral Streptococci
Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. The purpose of this study was to evaluate the interest to reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day treatment will be compared to the classical 7-day treatment for clinical efficacy (pain, wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.
Amoxicillin treatment starts the day of the inclusion in the study (day 0). Dentists and
participants were blinded to treatment assignment for the duration of the study. The
infected tooth was extracted 2 days after the beginning of the antibiotic treatment, and the
post-operative follow-up was done 1 week after tooth extraction (day 9). An additional
follow-up was done one month later (day 30).
Clinical parameters were collected one week after tooth extraction (day 9). Pain was
evaluated by its intensity during the days following surgery (using an analog visual scale
varying from 0 -no pain- to 10 -very intense pain-), and by the total amount (in mg) of
paracetamol ingested. The infectious state was evaluated by local wound healing, regional
adenopathy and fever. The wound healing score combined local inflammation and sensitivity,
and the presence or absence of a blood clot.
The streptococci resistance was assessed at the patient-level by the proportion of patient
with at least one resistant streptococcus, and at the streptococcus-level by the proportion
of resistant streptococcus out of the total streptococci flora. Intermediate susceptibility
to amoxicillin was defined as a minimum inhibitory concentration (MIC) of 0.5-16 mg/L;
resistance was defined as an MIC greater than or equal to 16 mg/L.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00645957 -
A Comparison of Redrubber Versus Penrose Drains
|
N/A |