Back to results

Immediate Versus Delayed Treatment of Odontogenic Infections

Primary Purpose

Focal Infection, Dental

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Amoxicillin

Tooth extraction

About this trial

This is an interventional treatment trial for Focal Infection, Dental focused on measuring Dentistry, Antibiotic, Penicillin, pediatrics

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Extraction Only

Average Dose Antibiotic

High Dose Antibiotic

Arm Description

Immediate extraction of infected tooth without antibiotic prescription.

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)

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)

Outcomes

Primary Outcome Measures

Change in diagnosis

Tooth infection not clinically detectable

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04057014

First Posted

August 12, 2019

Last Updated

October 2, 2020

Sponsor

Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04057014

Brief Title

Immediate Versus Delayed Treatment of Odontogenic Infections

Official Title

A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No funding available for the activity

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

October 2, 2020 (Actual)

Study Completion Date

October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focal Infection, Dental

Keywords

Dentistry, Antibiotic, Penicillin, pediatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Prospective partially randomized parallel study groups clinical trial investigation.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Extraction Only

Arm Type

Active Comparator

Arm Description

Immediate extraction of infected tooth without antibiotic prescription.

Arm Title

Average Dose Antibiotic

Arm Type

Experimental

Arm Description

Arm Title

High Dose Antibiotic

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Other Intervention Name(s)

Amoxil

Intervention Description

Antibiotic given at different dosages and durations.

Intervention Type

Procedure

Intervention Name(s)

Tooth extraction

Other Intervention Name(s)

Exodontia

Intervention Description

Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.

Primary Outcome Measure Information:

Title

Change in diagnosis

Description

Tooth infection not clinically detectable

Time Frame

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

Secondary Outcome Measure Information:

Title

Measure of pediatric oral health-related quality of life: the POQL

Description

Time Frame

Survey of quality of life at days 0, 5, 10 and 20.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keri Discepolo, DDS

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share participant data.

Citations:

PubMed Identifier

2926541

Citation

Dodson TB, Perrott DH, Kaban LB. Pediatric maxillofacial infections: a retrospective study of 113 patients. J Oral Maxillofac Surg. 1989 Apr;47(4):327-30. doi: 10.1016/0278-2391(89)90331-5.

Results Reference

background

PubMed Identifier

8089789

Citation

Biederman GR, Dodson TB. Epidemiologic review of facial infections in hospitalized pediatric patients. J Oral Maxillofac Surg. 1994 Oct;52(10):1042-5. doi: 10.1016/0278-2391(94)90172-4.

Results Reference

background

PubMed Identifier

17325089

Citation

Rush DE, Abdel-Haq N, Zhu JF, Aamar B, Malian M. Clindamycin versus Unasyn in the treatment of facial cellulitis of odontogenic origin in children. Clin Pediatr (Phila). 2007 Mar;46(2):154-9. doi: 10.1177/0009922806289431.

Results Reference

background

PubMed Identifier

18760616

Citation

Warnke PH, Becker ST, Springer IN, Haerle F, Ullmann U, Russo PA, Wiltfang J, Fickenscher H, Schubert S. Penicillin compared with other advanced broad spectrum antibiotics regarding antibacterial activity against oral pathogens isolated from odontogenic abscesses. J Craniomaxillofac Surg. 2008 Dec;36(8):462-7. doi: 10.1016/j.jcms.2008.07.001. Epub 2008 Aug 29.

Results Reference

background

PubMed Identifier

24717702

Citation

Kara A, Ozsurekci Y, Tekcicek M, Karadag Oncel E, Cengiz AB, Karahan S, Ceyhan M, Celik MO, Ozkaya-Parlakay A. Length of hospital stay and management of facial cellulitis of odontogenic origin in children. Pediatr Dent. 2014 Jan-Feb;36(1):18E-22E.

Results Reference

background

PubMed Identifier

16567986

Citation

Lin YT, Lu PW. Retrospective study of pediatric facial cellulitis of odontogenic origin. Pediatr Infect Dis J. 2006 Apr;25(4):339-42. doi: 10.1097/01.inf.0000216202.59529.3d.

Results Reference

background

PubMed Identifier

21972458

Citation

Huntington NL, Spetter D, Jones JA, Rich SE, Garcia RI, Spiro A 3rd. Development and validation of a measure of pediatric oral health-related quality of life: the POQL. J Public Health Dent. 2011 Summer;71(3):185-93.

Results Reference

background

PubMed Identifier

20637381

Citation

Thikkurissy S, Rawlins JT, Kumar A, Evans E, Casamassimo PS. Rapid treatment reduces hospitalization for pediatric patients with odontogenic-based cellulitis. Am J Emerg Med. 2010 Jul;28(6):668-72. doi: 10.1016/j.ajem.2009.02.028. Epub 2010 Apr 2.

Results Reference

background

Learn more about this trial

Immediate Versus Delayed Treatment of Odontogenic Infections

We'll reach out to this number within 24 hrs