Dental CariesICONNCT01496456

Radiographic Progression of Infiltrated Caries Lesions In-vivo

A study testing Resin infiltration and Caries management in people with Dental Caries, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions. Read more about this study

Who is it for?: Ages 14 to 35 years
Conditions the study is for: Dental Caries
What is being tested?: Resin infiltration and Caries management
Type of treatment: Pill or oral medicine, Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: May 2010to Jul 2014
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 14 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

14-35 year old subjects
decayed-missing-filled permanent teeth (DMFT) ≥ 3
having at least two early caries lesions in approximal posterior tooth surfaces
lesion 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.

United States1 site

University of Toledo Medical Center
Toledo, Ohio, 43614

Other trials in United States

About this study

This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

Read the detailed description

A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 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 infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.

Conditions: Dental Caries
Being tested: Resin infiltration, Caries management
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 (DMG, Germany)
Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy
Caries managementBehavioural
Also called Home use of over-the-counter oral health products
Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements

Study groups in NCT01496456
Study group	Role	What they receive
Preventative measures	Placebo comparator	Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation Receives: Behavioral: Caries management
Lesion infiltration	Active comparator	Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation Receives: Device: Resin infiltration; Behavioral: Caries management

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).
Measured: Baseline through 3 years

Secondary outcomes (2)

Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories
Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).
Measured: Baseline through 3 years
Lesion Survival After 3 Years
Discrete time survival analysis of time to first lesion progression.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jul 2014

First posted21 Dec 2011 (estimated)
Study startMay 2010
Primary completionJul 2014
Study completionJul 2014

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 (3)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: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496456
Sponsor's protocol ID: PG#N010508
Other IDs: 10-PAF03721
Acronym: ICON
Status last verified: Jul 2017
First submitted: 9 Dec 2011
Last updated: 8 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available.
PubMed 25080756
Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque

All Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiographic Progression of Infiltrated Caries Lesions In-vivo
ClinicalTrials.gov ID: NCT01496456
Acronym / sponsor ID: ICON / PG#N010508
Conditions: Dental Caries
Keywords: Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: DMG Dental Material Gesellschaft mbH
Study start: May 2010
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 21 Dec 2011 (estimated)
Results: Posted 14 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Preventative measures	Placebo comparator	Behavioral: Caries managementCaries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
Lesion infiltration	Active comparator	Device: Resin infiltration, Behavioral: Caries managementResin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Who may qualify

Ages: 14 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

14-35 year old subjects
decayed-missing-filled permanent teeth (DMFT) ≥ 3
having at least two early caries lesions in approximal posterior tooth surfaces
lesion 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 (DMG, Germany)Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy	Device	Lesion infiltration
Caries managementAlso: Home use of over-the-counter oral health productsSplit-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements	Behavioural	Lesion infiltration, Preventative measures

Primary outcome

Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
Time frame: Baseline through 3 years
Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

2 secondary outcomes

Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories
Time frame: Baseline through 3 years
Lesion Survival After 3 Years
Time frame: 3 years

Results and safety

Results posted to the registry on 14 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lesion Infiltration and Preventative Management Only	17	9

Primary outcome: Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)

Time frame: Baseline through 3 years. Number. Unit: Lesions

Measure	Lesion Infiltration n = 9	Preventative Measures n = 9
Value	2	11

Lesion Infiltration vs Preventative Measures: p = 0.002, Regression, Logistic

Population analysed: Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lesion Infiltration	0 of 16 (0%)	0 of 16 (0%)	Not reported
Preventative Measures	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): Small number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationPeters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
Results publication: PubMed 25080756Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available.
Results publicationPeters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.
Individual participant dataSharing planned: No

Related trials for Dental Caries

Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque

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 and Caries management 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 4 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 8 Aug 2017. 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 14 Jul 2016). 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 Showing Radiographic Progression as Measured by Lesion Size (Continuous) (time frame: Baseline through 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 NCT01496456, which also lists 3 linked publications.

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 8 Aug 2017.