Use of Radiographic Contrast to Detect Dental Caries
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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.
Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of early cavitation from 58% to 90%.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Device: Radiographic contrast agent.. Barium Sulfate. |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries |
- Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay. [ Time Frame: Immediately after application of contrast agent. ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 41 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Contrast
All subjects will be in one group who will have a control radiograph of teeth before applying the contrast agent when another radiograph will be taken to test for the presence of contrast in a cavity.
|
Device: Radiographic contrast agent.. Barium Sulfate.
Application of contrast topically to tooth immediately followed by radiograph.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| 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 inspection.
- the occlusal 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.
Contacts and Locations| Contact: Douglas K Benn, DDS PhD | 402-280-5025 | douglasbenn@creighton.edu |
| United States, Nebraska | |
| Creighton University School of Dentistry | Recruiting |
| Omaha, Nebraska, United States, 68178 | |
| Principal Investigator: | Douglas K Benn, DDS PhD | Creighton University |
More Information
No publications provided
| Responsible Party: | Douglas K Benn DDS, PhD, Professor and PI, Creighton University |
| ClinicalTrials.gov Identifier: | NCT01523509 History of Changes |
| Other Study ID Numbers: | CU IRB-01 |
| Study First Received: | January 27, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Creighton University:
|
Dental Caries Radiography, Dental Contrast media Tooth |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013