Use of Radiographic Contrast to Detect Dental Caries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01523509
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
Douglas K Benn DDS, PhD, Creighton University

January 27, 2012
February 1, 2012
June 17, 2016
August 2012
May 2013   (Final data collection date for primary outcome measure)
Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay. [ Time Frame: Immediately after application of contrast agent. ]
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.
Same as current
Complete list of historical versions of study NCT01523509 on Archive Site
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Use of Radiographic Contrast to Detect Dental Caries
The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries

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%.

Tooth sites will be recorded by tooth number, type of surface (mesial, distal,occlusal), cavitated, non-cavitated, healthy. Radiographs will similarly be scored.Although contrast agents are classified as drugs this is not a study of drug properties or effect on cells since the properties of the agent are already well know and its safety record well established. This study will be recording the radiopacity of the contrast agent on healthy tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for each surface type will be presence or absence of a radiopacity on a radiograph which will be made at the one and only visit for each study subject. The radiograph contains the data from the intervention (placement of contrast agent) and the outcome will be assessed some weeks later after the completion of the data collection.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Dental Caries
Device: Radiographic contrast agent. Sodium Iodide.
Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.
Experimental: Contrast
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.
Intervention: Device: Radiographic contrast agent. Sodium Iodide.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
19 Years to 99 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Douglas K Benn DDS, PhD, Creighton University
Creighton University
Not Provided
Principal Investigator: Douglas K Benn, DDS PhD Creighton University
Creighton University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP