Clinical trial NCT04057014: Immediate Versus Delayed Treatment of Odontogenic Infections
Official title: A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Focal Infection, Dental
Keywords: Dentistry
Antibiotic
Penicillin
pediatrics
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective partially randomized parallel study groups clinical trial investigation.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in diagnosis
timeFrame: Infection will be monitored at days 0, 5, 10 and 20.
Secondary outcomes:
measure: Measure of pediatric oral health-related quality of life: the POQL
timeFrame: Survey of quality of life at days 0, 5, 10 and 20.
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Keri Discepolo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.