Dental CariesNCT01584024
Resin Infiltration to Arrest Early Tooth Decay
A study testing Resin infiltration in people with Dental Caries, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Resin infiltration
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
- Having at least two early caries lesions in approximal posterior tooth surfaces
- Lesions visible on radiograph
Who cannot join
- Current participation in another clinical study
- Medically compromised subjects
- Hyposalivation
- Pregnancy
- Allergic to methylmethacrylates
- Allergic to latex
- Symptomatic teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Progression of Early Caries Lesions After Resin Infiltration
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
Read the detailed description
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.
- Conditions
- Dental Caries
- Being tested
- Resin infiltration, Sham treatment
- Keywords
- Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy
- Medical subject headings
- Dental Caries, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationDevice
Also called ICON Infiltration kit (DMG, Germany) (ICON=product name)
Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.
ICON product: FDA-510(k): K100062
Sham treatmentDevice
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration | Active comparator | Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) Receives: Device: Resin infiltration |
| Control | Sham comparator | Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
Measured: 3 Years
Secondary outcomes (1)
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- DMG Dental Material Gesellschaft mbH
- Responsible party
- Principal investigator, Mathilde Peters, DMD, PhD, University of Michigan
- Investigators
- Mathilde C Peters, DMD, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584024
- Sponsor's protocol ID
- N010508-S3
- Other IDs
- 12-PAF02598
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2012
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16.
PubMed 31526071
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Progression of Early Caries Lesions After Resin Infiltration
- ClinicalTrials.gov ID
- NCT01584024
- Acronym / sponsor ID
- N010508-S3
- Conditions
- Dental Caries
- Keywords
- Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- DMG Dental Material Gesellschaft mbH
- Study start
- Mar 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
Detailed description
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Active comparator | Device: Resin infiltrationResin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) |
| Control | Sham comparator | Device: Sham treatmentSham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
- Having at least two early caries lesions in approximal posterior tooth surfaces
- Lesions visible on radiograph
Key exclusion criteria (7 listed)
- Current participation in another clinical study
- Medically compromised subjects
- Hyposalivation
- Pregnancy
- Allergic to methylmethacrylates
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 |
|---|---|---|
| Resin infiltrationAlso: ICON Infiltration kit (DMG, Germany) (ICON=product name)Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062 | Device | Resin infiltration |
| Sham treatmentBaseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification. | Device | Control |
Primary outcome
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Time frame: 3 Years
Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
1 secondary outcome
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
Time frame: 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31526071Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16.
- Individual participant dataSharing planned: Undecided
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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.
Mathilde C Peters, DMD, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration in people with Dental Caries, run by University of Michigan 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 7 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 12 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) (time frame: 3 Years). 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 NCT01584024, 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 12 Feb 2019.