Use of Radiographic Contrast to Detect Dental Caries

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Douglas K Benn DDS, PhD, Creighton University
ClinicalTrials.gov Identifier:
NCT01523509
First received: January 27, 2012
Last updated: September 5, 2014
Last verified: September 2014

January 27, 2012
September 5, 2014
September 2014
November 2015   (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. ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Dental Caries
Device: Radiographic contrast agent. Sodium Iodide.
Application of 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 contrast agent when another radiograph will be taken to test for the presence of contrast in a cavity.
Intervention: Device: Radiographic contrast agent. Sodium Iodide.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
January 2016
November 2015   (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.
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01523509
CU IRB-01
No
Douglas K Benn DDS, PhD, Creighton University
Creighton University
Not Provided
Principal Investigator: Douglas K Benn, DDS PhD Creighton University
Creighton University
September 2014

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