Status:
WITHDRAWN
Immediate Versus Delayed Treatment of Odontogenic Infections
Lead Sponsor:
Boston Children's Hospital
Conditions:
Focal Infection, Dental
Eligibility:
All Genders
2-11 years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the physiologic resolution of dental infections between immediate tooth extraction (control group) and administration of systemic antibiotics and delayed extr...
Detailed Description
This is a prospective partially randomized clinical trial. Patients 2-11 years old who have a vestibular swelling associated with an odontogenic infection are being studied. Subjects will self-select ...
Eligibility Criteria
Inclusion
- Patients who present to the dental clinic or Boston Children's Hospital emergency room
- Odontogenic origin associated with a primary tooth and limited to the buccal vestibule only
- Ages of 2-11 years old
- Primary Caregiver present
- English speaking
- American Society of Anesthesiologists (ASA) classification of I
- None or current systemic antibiotic therapy regimen \< 24 hours
- Able to take medication orally
- Those patients who choose to participate in the study
Exclusion
- Infection that has spread beyond the buccal vestibule, or not detectable
- Infection is associated with a permanent adult tooth
- Ages of \<2 years old or \>11 years old
- American Society of Anesthesiologists classification of II or greater or poor general health.
- Renal impairment
- Immunosuppressive disease
- Recent antibiotic therapy in the last 1 to 30 days
- Allergy to penicillin
- Unable to take oral medications
- Decline participation
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04057014
Start Date
October 1 2020
End Date
October 2 2020
Last Update
October 6 2020
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