Immediate Versus Delayed Treatment of Odontogenic Infections

October 2, 2020 updated by: Keri Discepolo, Boston Children's Hospital

A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

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).

Study Overview

Status

Withdrawn

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).

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extraction Only
Immediate extraction of infected tooth without antibiotic prescription.
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Names:
  • Exodontia
Experimental: 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)
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Names:
  • Exodontia
Antibiotic given at different dosages and durations.
Other Names:
  • Amoxil
Experimental: 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)
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Names:
  • Exodontia
Antibiotic given at different dosages and durations.
Other Names:
  • Amoxil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diagnosis
Time Frame: Infection will be monitored at days 0, 5, 10 and 20.
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
Time Frame: Survey of quality of life at days 0, 5, 10 and 20.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Keri Discepolo, DDS, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Actual)

October 2, 2020

Study Completion (Actual)

October 2, 2020

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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