Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay
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|ClinicalTrials.gov Identifier: NCT02359279|
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : June 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Device: Sodium iodide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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): NCT02359279
|United States, Nebraska|
|Creighton University School of Dentistry|
|Omaha, Nebraska, United States, 68178|
|Principal Investigator:||Douglas Benn, DDS PhD||Creighton University & Firefly Health Innovations NE inc|