Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix

The University of Texas System (UT)

Status: Completed

Conditions: Odontogenic Deep Space Neck Infection

Treatments: Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR); Diagnostic Test: Microbial culture

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03772769

HSC-DB-18-0506

Details and patient eligibility

About

The purpose of the study is to evaluate the sensitivity and specificity of the Target Enriched Multiplex (TEM) polymerase chain reaction (PCR) platform for the rapid molecular diagnosis and treatment of odontogenic deep space neck infections.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.

Exclusion criteria

• Patients with gross communication between the abscess and the oral cavity will be excluded.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Subjects with advanced deep space odontogenic infection

Experimental group

Description:

Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.

Treatment:

Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)

Diagnostic Test: Microbial culture