Immediate Versus Delayed Treatment of Odontogenic Infections

Boston Children's Hospital

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Focal Infection, Dental

Interventions

AmoxicillinDRUG

Antibiotic given at different dosages and durations.

Tooth extractionPROCEDURE

Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Change in diagnosis

Tooth infection not clinically detectable

Time frame: Infection will be monitored at days 0, 5, 10 and 20.

Secondary Outcomes

Measure of pediatric oral health-related quality of life: the POQL

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.

Time frame: Survey of quality of life at days 0, 5, 10 and 20.

Data from ClinicalTrials.gov

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