Use of Radiographic Contrast to Detect Dental Caries

NCT01523509 | Completed Phase 1

• 1 other identifier: CU IRB-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed test is intended to enable dentists to differentiate between cavitated and non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces). In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns, pain, root canals, and possible later loss of teeth. Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of early cavitation from 58% to 90%.

Conditions

Dental Caries

Keywords

Dental Caries; Radiography, Dental; Contrast media; Tooth

Outcome Measures

Primary Outcomes (1)

• Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay.

  The PI will perform the clinical application of the contrast agent and radiograph the subject. In this way it will be known that the data has been collected. At a later date 3 independent dentists will be provided with blinded radiographs in a randomized order to report the presence or absence of cavitated caries lesions.

  Immediately after application of contrast agent.

Study Arms (1)

Contrast

EXPERIMENTAL

All subjects will be in one group who will have a control radiograph of teeth before applying the Sodium Iodide contrast agent topically between the teeth (the intervention) when another radiograph will be taken to test for the presence of contrast in a cavity.

Device: Radiographic contrast agent. Sodium Iodide.

Interventions

Radiographic contrast agent. Sodium Iodide. DEVICE

Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.

Contrast

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual inspection.
• the occlusal plane should be normal so that the interproximal contact regions are normal.
• English or Spanish speaker.

You may not qualify if:

• pregnant women
• a person who has participated in a similar study involving dental radiography within the last 12 months.
• fillings must not be present in the regions of interest.

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University School of Dentistry

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

• Benn DK, Cooper RL, Nunn ME, Edwards SE, Rocha-Sanchez SM. A radiographic method for distinguishing noncavitated from cavitated proximal carious lesions: A proof of concept clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Dec;132(6):715-726. doi: 10.1016/j.oooo.2021.02.014. Epub 2021 Feb 23.

  PMID: 34083157 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Douglas K Benn, DDS PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and PI

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

US (1)