Immediate Versus Delayed Treatment of Odontogenic Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2020-10-02

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Focal Infection, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective partially randomized parallel study groups clinical trial investigation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extraction Only

Immediate extraction of infected tooth without antibiotic prescription.

Group Type ACTIVE_COMPARATOR

Tooth extraction

Intervention Type PROCEDURE

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

Average Dose Antibiotic

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)

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

Antibiotic given at different dosages and durations.

Tooth extraction

Intervention Type PROCEDURE

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

High Dose Antibiotic

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)

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

Antibiotic given at different dosages and durations.

Tooth extraction

Intervention Type PROCEDURE

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

Interventions

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Amoxicillin

Antibiotic given at different dosages and durations.

Intervention Type DRUG

Tooth extraction

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

Intervention Type PROCEDURE

Other Intervention Names

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Amoxil Exodontia

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes