Dental CariesPhase 1NCT01523509
Use of Radiographic Contrast to Detect Dental Caries
A Phase 1 study testing Radiographic contrast agent. Sodium Iodide. in people with Dental Caries, run by Creighton University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Radiographic contrast agent. Sodium Iodide.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University School of Dentistry
Omaha, Nebraska, 68178
About this study
Official title: The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries
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%.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Radiographic contrast agent. Sodium Iodide.
- Keywords
- Dental Caries, Radiography, Dental, Contrast media, Tooth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic contrast agent. Sodium Iodide.Device
Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.
| Study group | Role | What they receive |
|---|---|---|
| Contrast | Experimental | 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. Receives: Device: Radiographic contrast agent. Sodium Iodide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after application of contrast agent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas K Benn DDS, PhD, Creighton University
- Investigators
- Douglas K Benn, DDS PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523509
- Sponsor's protocol ID
- CU IRB-01
- Status last verified
- Jun 2016
- First submitted
- 27 Jan 2012
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34083157
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Radiographic Contrast to Differentiate Cavitated From Non-cavitated Dental Caries
- ClinicalTrials.gov ID
- NCT01523509
- Acronym / sponsor ID
- CU IRB-01
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Radiography, Dental, Contrast media, Tooth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast | Experimental | Device: 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. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic contrast agent. Sodium Iodide.Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph. | Device | Contrast |
Primary outcome
Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Derived from this study: PubMed 34083157Benn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas K Benn, DDS PhD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiographic contrast agent. Sodium Iodide. in people with Dental Caries, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a radiopacity below the tooth surface at a site likely to develop tooth decay. (time frame: Immediately after application of contrast agent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.