NCT02359279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

February 2, 2015

Last Update Submit

June 15, 2016

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Contrast

EXPERIMENTAL

All subjects will be in one group who will have a control radiograph before applying sodium iodide to interproximal surfaces of teeth when another radiograph will be taken to test for the presence of caries cavitation.

Device: Sodium iodide

Interventions

Sodium iodideDEVICE

Comparison of control radiographs made before application of sodium iodide and test radiograph after application.

Contrast

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University School of Dentistry

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

  • 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.

    PMID: 34083157DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Douglas Benn, DDS PhD

    Creighton University & Firefly Health Innovations NE inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)