Status:
UNKNOWN
Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Children's Hospital Colorado
Conditions:
Caries,Dental
Eligibility:
All Genders
5-9 years
Brief Summary
Specific Aims 1. To determine the diagnostic efficacy of CariVu and BWX for detecting interproximal carious lesions in primary dentition BWX and CariVu images will be taken in random order. Numbe...
Detailed Description
Dental caries is a common disease\[1\] affecting 621 million children in 2010\[2\]. Dental caries in children commonly result in dental pain, infection and missed school days \[3\]. The financial burd...
Eligibility Criteria
Inclusion
- Pediatric patients from 5-9 years of age
- Justification for this age range: Patients younger than 5 years may have open contacts between primary molars.
- Patients more than 9 years may have advanced root resorption and primary teeth might be at advanced stages of exfoliation
- Patients with American Society of Anesthesiologists classification (ASA)-I or II category (medically healthy)
- Parent or legal guardian should consent BWX \[per American Academy of Pediatric Dentistry (AAPD) guidelines\] and CariVu ™ (Dexis) imaging to be completed during same visit
- All selected patients should be in primary or mixed dentition stage with well-established contacts between posterior teeth
- Patient with Frankl behavior assessment score of 3 ("positive") or 4 ("definitely-positive")
- Patient and parent speaking English or Spanish as their preferred language Justification for language: Language barriers may pose challenges to behavior management in pediatric dental patient and thereby reducing the acceptability of dental treatment (confounding factor).
Exclusion
- Patients with ASA III or IV (medically complex or special health care needs patient)
- Patients with open contacts between teeth or missing teeth
- Patients who do not need conventional bitewing radiographs per AAPD guidelines
- Patient with Frankl behavior assessment score of 1 ("definitely negative") or 2 ("negative")
Key Trial Info
Start Date :
October 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05362461
Start Date
October 31 2022
End Date
January 31 2023
Last Update
November 1 2022
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80011