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NCT01523509 · ClinicalTrials.gov registry record · Phase 1

Use of Radiographic Contrast to Detect Dental Caries

A Phase 1 study, sponsored by Creighton University.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT01523509: Completed Phase 1 study, sponsored by Creighton University.

NCT01523509 is a Phase 1 study that has completed, run by Creighton University. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01523509, a Phase 1 study, has completed, sponsored by Creighton University.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study 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%.

Primary Outcome

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.

Interventions

  • DEVICE Radiographic contrast agent. Sodium Iodide.

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2012-08
Est. Completion 2013-05
Phase Phase 1
Creighton University

98 total trials

What the finished NCT01523509 record still lists

NCT01523509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 1 intervention - of which Radiographic contrast agent. Sodium Iodide. is the first listed.

NCT01523509 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01523509 about?

NCT01523509 is a clinical study titled "Use of Radiographic Contrast to Detect Dental Caries". 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 t...

What is the current status of trial NCT01523509?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-08. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01523509?

The interventions under investigation include: Radiographic contrast agent. Sodium Iodide. (DEVICE).

Who is sponsoring clinical trial NCT01523509?

This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01523509's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01523509, the US trial registry maintained by the National Library of Medicine. NCT01523509 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.