Immediate Versus Delayed Treatment of Odontogenic Infections
- Conditions
- Focal Infection, Dental
- Interventions
- Procedure: Tooth extraction
- Registration Number
- NCT04057014
- Lead Sponsor
- Boston Children's Hospital
- 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 extraction (study groups 1 and 2). A secondary objective is two compare two different antibiotic regimens in the delayed extraction groups (study group 1 and 2).
- 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 into the control or study group. All subjects will be offered to have the tooth extracted on the day of diagnosis, and if this treatment is chosen they will join the control group (group 1). Subjects who defer treatment will be placed on amoxicillin and will be placed into the study group. The study group will be randomized into two parallel study groups that either have average dose antibiotics for 10 days (group 2), or maximum dose antibiotics for 5 days (group 3).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose Antibiotic Tooth extraction High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients) Extraction Only Tooth extraction Immediate extraction of infected tooth without antibiotic prescription. Average Dose Antibiotic Tooth extraction Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (\*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group) Average Dose Antibiotic Amoxicillin Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (\*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group) High Dose Antibiotic Amoxicillin High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients)
- Primary Outcome Measures
Name Time Method Change in diagnosis Infection will be monitored at days 0, 5, 10 and 20. Tooth infection not clinically detectable
- Secondary Outcome Measures
Name Time Method Measure of pediatric oral health-related quality of life: the POQL Survey of quality of life at days 0, 5, 10 and 20. Quality of life compared between arms. Pediatric Oral Health Quality of Life (PQOL) clustered into four dimensions - Physical Functioning, Role Functioning, Social Functioning and Emotional Functioning. It was designed to be used in high risk, low resource, populations with greater health disparities. Specifically we are looking significant difference between the study groups that is at least 2 standard errors from the control group. If there are not two deviations to discriminate between scales would indicate a non-significant finding.