WithdrawnPhase 4

Immediate Versus Delayed Treatment of Odontogenic Infections

Stopped: No funding available for the activity

0Started 2020-10

Plain-language 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).

Who can participate

Age range

2 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in diagnosis

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

Trial details

NCT IDNCT04057014

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-02

View on ClinicalTrials.gov More Focal Infection, Dental trials