Expired Study
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Omaha, Nebraska 68178


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.


Study summary:

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.


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 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.


Study is Available At:


Original ID:

2R42DE023003-02


NCT ID:

NCT02359279


Secondary ID:


Study Acronym:


Brief Title:

Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay


Official Title:

Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Creighton University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Douglas Benn, DDS PhD
Principal Investigator
Creighton University & Firefly Health Innovations NE inc

Study Dates

Start Date:August 2015
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:June 2016
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 15, 2016
First Received Date:February 2, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of cavitated versus non-cavitated caries lesions in 116 tooth surfaces.
Time Frame:Immediately after application of sodium iodide
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:Sodium iodide
Description:Comparison of control radiographs made before application of sodium iodide and test radiograph after application.
Arm Name:Contrast

Study Arms

Study Arm Type:Experimental
Arm Name:Contrast
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Creighton University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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