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Use of Radiographic Contrast to Detect Dental Caries

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiographic contrast agent. Sodium Iodide.
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Caries focused on measuring Dental Caries, Radiography, Dental, Contrast media, Tooth

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Creighton University School of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast

Arm Description

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.

Outcomes

Primary Outcome Measures

Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay.
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2012
Last Updated
June 15, 2016
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT01523509
Brief Title
Use of Radiographic Contrast to Detect Dental Caries
Official Title
The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Creighton University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental Caries, Radiography, Dental, Contrast media, Tooth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contrast
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiographic contrast agent. Sodium Iodide.
Intervention Description
Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.
Primary Outcome Measure Information:
Title
Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay.
Description
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.
Time Frame
Immediately after application of contrast agent.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Benn, DDS PhD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University School of Dentistry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34083157
Citation
Benn DK, Cooper RL, Nunn ME, Edwards SE, Rocha-Sanchez SM. A radiographic method for distinguishing noncavitated from cavitated proximal carious lesions: A proof of concept clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Dec;132(6):715-726. doi: 10.1016/j.oooo.2021.02.014. Epub 2021 Feb 23.
Results Reference
derived

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Use of Radiographic Contrast to Detect Dental Caries

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