Use of Radiographic Contrast to Detect Dental Caries
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|ClinicalTrials.gov Identifier: NCT01523509|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : June 17, 2016
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 or disease||Intervention/treatment||Phase|
|Dental Caries||Device: Radiographic contrast agent. Sodium Iodide.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01523509
|United States, Nebraska|
|Creighton University School of Dentistry|
|Omaha, Nebraska, United States, 68178|
|Principal Investigator:||Douglas K Benn, DDS PhD||Creighton University|