Immediate Versus Delayed Treatment of Odontogenic Infections

Study Overview
=================
Brief 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).

Official Title
-----------------
A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

Conditions
-----------------
Focal Infection, Dental

Intervention / Treatment
-----------------
* Drug: Amoxicillin
* Procedure: Tooth extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective partially randomized parallel study groups clinical trial investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extraction Only<br>Immediate extraction of infected tooth without antibiotic prescription. | Procedure: Tooth extraction<br>* Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.<br>* Other names: Exodontia;|
| Experimental: Average Dose Antibiotic<br>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) | Drug: Amoxicillin<br>* Antibiotic given at different dosages and durations.<br>* Other names: Amoxil;Procedure: Tooth extraction<br>* Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.<br>* Other names: Exodontia;|
| Experimental: High Dose Antibiotic<br>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) | Drug: Amoxicillin<br>* Antibiotic given at different dosages and durations.<br>* Other names: Amoxil;Procedure: Tooth extraction<br>* Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.<br>* Other names: Exodontia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diagnosis | Tooth infection not clinically detectable | Infection will be monitored at days 0, 5, 10 and 20. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Survey of quality of life at days 0, 5, 10 and 20. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dentistry, Antibiotic, Penicillin, pediatrics