Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

Dental Caries Clinical Trial

Official title:

Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359279
• Other study ID #: 2R42DE023003-02
• Status: Completed
• Phase: N/A
• First received: February 2, 2015
• Last updated: June 15, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Tooth sites will be recorded by both 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 known 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• Must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual examination.

The occlusal plane 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Sodium iodide
Comparison of control radiographs made before application of sodium iodide and test radiograph after application.

Locations

Country	Name	City	State
United States	Creighton University School of Dentistry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cavitated versus non-cavitated caries lesions in 116 tooth surfaces.	The PI will perform the clinical application of the sodium iodide and radiograph the subject. A control radiograph will be taken of tooth crowns before the application of the contrast. Immediately after the contrast application another radiograph will be exposed. If caries is present a lucency will be seen in the control The test radiograph will show either contrast on the tooth surface (non-cavitated) or below the surface (caviiatetd). Rubber impressions will be made of the tooth surfaces and scanned with a laser to provide a 3D replica which will be the gold standard for presence or absence of cavitation. 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 cries lesions.	Immediately after application of sodium iodide	No