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Immediate Versus Delayed Treatment of Odontogenic Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057014
Recruitment Status : Withdrawn (No funding available for the activity)
First Posted : August 14, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Keri Discepolo, Boston Children's Hospital

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).

Condition or disease Intervention/treatment Phase
Focal Infection, Dental Drug: Amoxicillin Procedure: Tooth extraction Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective partially randomized parallel study groups clinical trial investigation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections
Estimated Study Start Date : October 2020
Actual Primary Completion Date : October 2, 2020
Actual Study Completion Date : October 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Extraction Only
Immediate extraction of infected tooth without antibiotic prescription.
Procedure: Tooth extraction
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Name: 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)
Drug: Amoxicillin
Antibiotic given at different dosages and durations.
Other Name: Amoxil

Procedure: Tooth extraction
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Name: Exodontia

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)
Drug: Amoxicillin
Antibiotic given at different dosages and durations.
Other Name: Amoxil

Procedure: Tooth extraction
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
Other Name: Exodontia




Primary Outcome Measures :
  1. Change in diagnosis [ Time Frame: Infection will be monitored at days 0, 5, 10 and 20. ]
    Tooth infection not clinically detectable


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057014


Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Keri Discepolo, DDS Boston Children's Hospital
Publications:

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Responsible Party: Keri Discepolo, Associate Dentist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04057014    
Other Study ID Numbers: P00030880
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share participant data.

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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
Keywords provided by Keri Discepolo, Boston Children's Hospital:
Dentistry
Antibiotic
Penicillin
pediatrics
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Focal Infection
Focal Infection, Dental
Tooth Diseases
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents