Use of Radiographic Contrast to Detect Dental Caries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

NCT02359279

Dental Caries

COMPLETED NA

Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?

NCT03181711

Caries

COMPLETED

Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth

NCT02078453

Dental Caries Teeth Loss Quality of Life

COMPLETED NA

Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection

NCT02657538

Dental Caries

COMPLETED NA

3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression

NCT05409625

Dental Caries

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Contrast

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.

Group Type EXPERIMENTAL

Radiographic contrast agent. Sodium Iodide.

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiographic contrast agent. Sodium Iodide.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes