Use of Radiographic Contrast to Detect Dental Caries

Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Device: Radiographic contrast agent. Sodium Iodide.

• Registration Number: NCT01523509
• Lead Sponsor: Creighton University

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.

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Study Start: 2012-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast	Radiographic contrast agent. Sodium Iodide.	All subjects will be in one group who will have a control radiograph of teeth before applying the Sodium Iodide contrast agent topically between the teeth (the intervention) when another radiograph will be taken to test for the presence of contrast in a cavity.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Creighton University School of Dentistry; 🇺🇸 Omaha, Nebraska, United States