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Use of Radiographic Contrast to Detect Dental Caries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas K Benn DDS, PhD, Creighton University
ClinicalTrials.gov Identifier:
NCT01523509
First received: January 27, 2012
Last updated: June 15, 2016
Last verified: June 2016
  Purpose

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%.


Condition Intervention Phase
Dental Caries
Device: Radiographic contrast agent. Sodium Iodide.
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Radiographic contrast agent. Sodium Iodide.
Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   19 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523509

Locations
United States, Nebraska
Creighton University School of Dentistry
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Douglas K Benn, DDS PhD Creighton University
  More Information

Responsible Party: Douglas K Benn DDS, PhD, Professor and PI, Creighton University
ClinicalTrials.gov Identifier: NCT01523509     History of Changes
Other Study ID Numbers: CU IRB-01 
Study First Received: January 27, 2012
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Creighton University:
Dental Caries
Radiography, Dental
Contrast media
Tooth

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016