Immediate Versus Delayed Treatment of Odontogenic Infections

Focal Infection, Dental Clinical Trial

Official title:

A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04057014
• Other study ID #: P00030880
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2020
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Focal Infection, Dental
• Infection

Intervention

Drug:
• Amoxicillin
Antibiotic given at different dosages and durations.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

References & Publications (8)

Biederman GR, Dodson TB. Epidemiologic review of facial infections in hospitalized pediatric patients. J Oral Maxillofac Surg. 1994 Oct;52(10):1042-5. — View 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. — View 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. — View 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. — View Citation

Lin YT, Lu PW. Retrospective study of pediatric facial cellulitis of odontogenic origin. Pediatr Infect Dis J. 2006 Apr;25(4):339-42. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diagnosis	Tooth infection not clinically detectable	Infection will be monitored at days 0, 5, 10 and 20.
Secondary	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.