Immediate Versus Delayed Treatment of Odontogenic Infections

NCT04057014 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: P00030880
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Focal Infection, Dental

Keywords

Dentistry; Antibiotic; Penicillin; pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in diagnosis

  Tooth infection not clinically detectable

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

Secondary Outcomes (1)

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

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

Study Arms (3)

Extraction Only

ACTIVE COMPARATOR

Immediate extraction of infected tooth without antibiotic prescription.

Procedure: Tooth extraction

Average Dose Antibiotic

EXPERIMENTAL

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; Procedure: Tooth extraction

High Dose Antibiotic

EXPERIMENTAL

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; Procedure: Tooth extraction

Interventions

Amoxicillin DRUG

Antibiotic given at different dosages and durations.

Also known as: Amoxil

Average Dose Antibiotic; High Dose Antibiotic

Tooth extraction PROCEDURE

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

Also known as: Exodontia

Average Dose Antibiotic; Extraction Only; High Dose Antibiotic

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related Publications (8)

• 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.

  PMID: 2926541 BACKGROUND

• 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.

  PMID: 8089789 BACKGROUND

• 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.

  PMID: 17325089 BACKGROUND

• 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.

  PMID: 18760616 BACKGROUND

• 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.

  PMID: 24717702 BACKGROUND

• 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.

  PMID: 16567986 BACKGROUND

• 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.

  PMID: 21972458 BACKGROUND

• 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.

  PMID: 20637381 BACKGROUND

MeSH Terms

Conditions

Focal Infection, Dental

Interventions

Amoxicillin; Tooth Extraction

Condition Hierarchy (Ancestors)

Focal Infection; Infections; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Keri Discepolo, DDS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dentist

Model Details: Prospective partially randomized parallel study groups clinical trial investigation.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: October 1, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share