Immediate Versus Delayed Treatment of Odontogenic Infections

Boston Children's Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Focal Infection, Dental

Treatments: Procedure: Tooth extraction; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT04057014

P00030880

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 2 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Extraction Only

Active Comparator group

Description:

Immediate extraction of infected tooth without antibiotic prescription.

Treatment:

Procedure: Tooth extraction

Average Dose Antibiotic

Experimental group

Description:

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)

Treatment:

Drug: Amoxicillin

Procedure: Tooth extraction

High Dose Antibiotic

Experimental group

Description:

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)

Treatment:

Drug: Amoxicillin

Procedure: Tooth extraction