Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
Not Applicable
Completed
- Conditions
- Odontogenic Deep Space Neck Infection
- Interventions
- Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)Diagnostic Test: Microbial culture
- Registration Number
- NCT03772769
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects with advanced deep space odontogenic infection Target Enriched Multiplex PCR (TEM- PCR) Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture. Subjects with advanced deep space odontogenic infection Microbial culture Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
- Primary Outcome Measures
Name Time Method Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture Baseline (at the time the sample was obtained from the patient)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Th University of Texas Health Science Center at Houston
đŸ‡ºđŸ‡¸Houston, Texas, United States