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Trial record 12 of 1236 for:    tooth decay

Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

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: NCT02359279
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : June 16, 2016
Information provided by (Responsible Party):
Douglas K Benn DDS, PhD, Creighton University

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.

Condition or disease Intervention/treatment Phase
Dental Caries Device: Sodium iodide Not Applicable

Detailed Description:
Tooth sites will be recorded by both 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 known 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Contrast
All subjects will be in one group who will have a control radiograph before applying sodium iodide to interproximal surfaces of teeth when another radiograph will be taken to test for the presence of caries cavitation.
Device: Sodium iodide
Comparison of control radiographs made before application of sodium iodide and test radiograph after application.

Primary Outcome Measures :
  1. Number of cavitated versus non-cavitated caries lesions in 116 tooth surfaces. [ Time Frame: Immediately after application of sodium iodide ]
    The PI will perform the clinical application of the sodium iodide and radiograph the subject. A control radiograph will be taken of tooth crowns before the application of the contrast. Immediately after the contrast application another radiograph will be exposed. If caries is present a lucency will be seen in the control The test radiograph will show either contrast on the tooth surface (non-cavitated) or below the surface (caviiatetd). Rubber impressions will be made of the tooth surfaces and scanned with a laser to provide a 3D replica which will be the gold standard for presence or absence of cavitation. 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 cries lesions.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual examination.

The occlusal plane 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02359279

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United States, Nebraska
Creighton University School of Dentistry
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
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Principal Investigator: Douglas Benn, DDS PhD Creighton University & Firefly Health Innovations NE inc

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Responsible Party: Douglas K Benn DDS, PhD, Principal Investigator, Creighton University Identifier: NCT02359279     History of Changes
Other Study ID Numbers: 2R42DE023003-02 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs