NCT01523509

Use of Radiographic Contrast to Detect Dental Caries

The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Creighton University · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Accepted

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. Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of early cavitation from 58% to 90%.

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	Radiographic contrast agent. Sodium Iodide.	Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-02-01
• Last updated: 2016-06-17

Locations

1 site across 1 country: United States