Dental CariesNCT02359279
Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay
A study testing 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?
- Sodium iodide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2016
- Phase
- Interventional
- 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 examination.
- The occlusal plane 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
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.
Read the detailed 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.
- Conditions
- Dental Caries
- Being tested
- Sodium iodide
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium iodideDevice
Comparison of control radiographs made before application of sodium iodide and test radiograph after application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sodium iodide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after application of sodium iodide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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 Benn, DDS PhD, Principal investigator, Creighton University & Firefly Health Innovations NE inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359279
- Sponsor's protocol ID
- 2R42DE023003-02
- Status last verified
- Jun 2016
- First submitted
- 2 Feb 2015
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay
- ClinicalTrials.gov ID
- NCT02359279
- Acronym / sponsor ID
- 2R42DE023003-02
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Feb 2015 (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.
Detailed 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.
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: Sodium iodideAll 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. |
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 examination.
- The occlusal plane plane should be normal so that the interproximal contact regions are normal.
- English or Spanish speaker.
Key exclusion criteria (2 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 |
|---|---|---|
| Sodium iodideComparison of control radiographs made before application of sodium iodide and test radiograph after application. | Device | Contrast |
Primary outcome
Number of cavitated versus non-cavitated caries lesions in 116 tooth surfaces.
Time frame: Immediately after application of sodium iodide
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.
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 16 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.
- Individual participant dataSharing planned: No
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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 Benn, DDS PhD principal investigator
Creighton University & Firefly Health Innovations NE inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 2 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 16 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.
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?
Number of cavitated versus non-cavitated caries lesions in 116 tooth surfaces. (time frame: Immediately after application of sodium iodide). 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 NCT02359279, 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 16 Jun 2016.