Use of Radiographic Contrast to Detect Dental Caries

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01523509

Enrollment

Registered

2012-02-01

Start date

2012-08-31

Completion date

2013-05-31

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Dental Caries, Radiography, Dental, Contrast media, Tooth

Brief 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.

Interventions

DEVICERadiographic contrast agent. Sodium Iodide.

Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay.	Immediately after application of contrast agent.	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026