NCT04057014

Immediate Versus Delayed Treatment of Odontogenic Infections

A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Accepted

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).

Conditions

• Focal Infection, Dental

Interventions

Type	Name	Description
DRUG	Amoxicillin	Antibiotic given at different dosages and durations.
PROCEDURE	Tooth extraction	Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-10-02
• Completion: 2020-10-02
• First posted: 2019-08-14
• Last updated: 2020-10-06

Regulatory

• FDA-regulated drug study