Caries,DentalNCT01796106
Clinical Trial Proximal Caries Infiltration and Detection
A study testing Resin infiltration and Fluoride varnish & Oral hygiene instruction in people with Caries,Dental, run by DMG Dental Material Gesellschaft mbH at 1 site in United States.
Trial summary
The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions in primary molars over 24 months. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Resin infiltration and Fluoride varnish & Oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-13 years
- Early caries lesions in primary molars (depth: E1 or E2)
- Good general health
- Available for 12 \& 24 months recalls
- Signed consent/assent/HIPAA
- Criteria used to assess teeth for acceptance into this study:
- Teeth fully erupted, in functional occlusion and
- Radiographic evidence of early caries in interproximal areas
Who cannot join
- Participation in other study
- History of adverse reaction on clinical material
- Sensitivity during screening test
- Poor access to teeth
- Patient refusing radiographic examination
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Pediatric Dentistry
Seattle, Washington, 98115
About this study
Official title: Clinical Efficacy of Caries Infiltration (Icon) - A Randomized, Blinded and Controlled Pilot Study of Early Caries Progression Detection
The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions in primary molars over 24 months. In addition, this study will assess the use of a scanning fiber endoscope (SFE) laser optical device for the assessment of caries lesions and their progression in comparison to radiographic examination.
A total of 50 participants (age 6-13 years) with at least 1 proximal early caries lesion will be enrolled. The participants will be followed up at 12 and 24 months. Lesion status will be monitored through radiographic and SFE laser optical device imaging.
Read the detailed description
Introduction: Dental caries remains one of the most prevalent diseases worldwide. It is a dynamic process that causes destruction of tooth structure by dissolving the enamel. While it is possible to restore the structure and function of the tooth by placing a filling, it is preferable to slow down or reverse the caries process at an early state. Proximal surfaces are hereby particularly susceptible to caries as the contact area between teeth is difficult to access. While non-invasive techniques such as remineralization (using topical fluoride) or biofilm control are options to manage early caries lesions, their effectiveness may be compromised due to poor patient compliance. Alternatives are micro-invasive strategies such as resin infiltration, whereby a highly viscous resin is infiltrated into the porous enamel of caries lesions to erect an internal barrier that blocks acid diffusion, thereby inhibiting caries lesion progression.
Another important aspect in caries management is diagnostic, with visual-tactile examination and radiographs being standard of care. However, visual-tactile techniques are known to be unreliable due to subjectivity and fail to differentiate between varies stages of caries progression. Caries diagnostic is thus assisted by radiographic imaging, which however, also has a limited sensitivity and requires the use of x-rays. While alternatives for caries imaging have been developed (e.g. quantitative laser or light fluorescence (QLF) or electrical conductance measurements (ECM)) no gold standard could be established so far highlighting the need for new save and sensitive imaging techniques.
Objective: To assess the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions over 24 months. In addition, the use of a SFE laser optical device for the assessment of caries lesions and their progression will be assessed in comparison to radiographic examination.
Materials and Methods: 50 volunteers (age 6-13 years) with at least 1 proximal early caries lesion in primary molars will be enrolled and randomly assigned to the resin infiltration and control groups. In the resin infiltration group early caries lesions will be treated using Icon (DMG), whereas the lesions in the control group will be managed using Oral Hygiene Instructions (OHI) and topical fluoridation (Duraphat Fluoride Varnish, Colgate). Lesion depth will be assessed through radiographic evaluation as well as through a novel optical device based on scanning fiber endoscope (SFE) technology for early caries detection through laser light imaging. SFE laser optical device prototypes developed by the University of Washington's Human Photonics Lab (HPL) will be utilized. Such a device is already in human use for applications such as imaging and cancer screening.
Clinical Significance: Resin infiltration of early caries lesions may be an effective therapeutic strategy in paediatric dentistry to reduce caries progression. Additionally, the SFE optical device may be suitable technology to visualize early caries lesions and their progression, which would offer a safe alternative to radiography for assessing and monitoring dental caries.
- Conditions
- Caries,Dental
- Being tested
- Resin infiltration, Fluoride varnish & Oral hygiene instruction
- Keywords
- Caries infiltration, Resin infiltration, Caries progression, Icon
- Medical subject headings
- Dental Caries
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), approximal resin infiltration kit
Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth, the study lesions will be treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions. Essentially, the treatment consists of the following parts: 1) isolating the tooth with a rubber dam and cleaning its surface; 2) removing/ conditioning the surface layer of the lesion (using Icon-Etch) to open the lesion body; 3) drying of the exposed porous enamel; 4) infiltrating the existing pore volume with the resin infiltrant (Icon Infiltrant); 5) light curing of the resin infiltrant; 6) repeating the infiltration step including light curing; followed by 7) finalizing using interproximal finishing/polishing strips.
Fluoride varnish & Oral hygiene instructionDevice
Also called Duraphat Fluoride Varnish (Colgate, USA)
Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy will be provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) will be used according to manufactures´ instructions.
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration | Experimental | Enrolled proximal early caries lesions will be treated using the resin infiltrant Icon (DMG, Germany). Receives: Device: Resin infiltration |
| Fluoride varnish & Oral hygiene instruction | Active comparator | Oral hygiene instruction and topical fluoridation therapy (Duraphat Fluoride Varnish, Colgate, USA) will be provided. Receives: Device: Fluoride varnish & Oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Change in categorical lesion depth (progression to next depth category lesion; E1->E2->D1->D2->filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).
Measured: 24 months
Secondary outcomes (2)
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging
Categorical lesion depth (E1, E2, D1, D2) is measured using SFE imaging. The results are compared to the assessment of categorical lesion depth using radiographic imaging (state of the art method). Outcomes are defined as follows: 1) positive (if SFE imaging gave the same result as the radiograph analysis), 2) negative (if SFE imaging gave a different result as the radiograph analysis) and 3) failure (if lesion depth could not be assessed using SFE imaging).
Categorical lesion depth: E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).
Measured: 0, 12 and 24 months
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Change in categorical lesion depth (progression to next depth category lesion; E1->E2->D1->D2->filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Recruitment slower than expected.
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 Caries,DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Berg, DDS, MS, Principal investigator, The Center for Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796106
- Sponsor's protocol ID
- DETECT13
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2012
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.
PubMed 15897335
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Caries Infiltration (Icon) - A Randomized, Blinded and Controlled Pilot Study of Early Caries Progression Detection
- ClinicalTrials.gov ID
- NCT01796106
- Acronym / sponsor ID
- DETECT13
- Conditions
- Caries,Dental
- Keywords
- Caries infiltration, Resin infiltration, Caries progression, Icon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slower than expected.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 19 Jul 2023
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 investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions in primary molars over 24 months. In addition, this study will assess the use of a scanning fiber endoscope (SFE) laser optical device for the assessment of caries lesions and their progression in comparison to radiographic examination.
A total of 50 participants (age 6-13 years) with at least 1 proximal early caries lesion will be enrolled. The participants will be followed up at 12 and 24 months. Lesion status will be monitored through radiographic and SFE laser optical device imaging.
Detailed description
Introduction: Dental caries remains one of the most prevalent diseases worldwide. It is a dynamic process that causes destruction of tooth structure by dissolving the enamel. While it is possible to restore the structure and function of the tooth by placing a filling, it is preferable to slow down or reverse the caries process at an early state. Proximal surfaces are hereby particularly susceptible to caries as the contact area between teeth is difficult to access. While non-invasive techniques such as remineralization (using topical fluoride) or biofilm control are options to manage early caries lesions, their effectiveness may be compromised due to poor patient compliance. Alternatives are micro-invasive strategies such as resin infiltration, whereby a highly viscous resin is infiltrated into the porous enamel of caries lesions to erect an internal barrier that blocks acid diffusion, thereby inhibiting caries lesion progression.
Another important aspect in caries management is diagnostic, with visual-tactile examination and radiographs being standard of care. However, visual-tactile techniques are known to be unreliable due to subjectivity and fail to differentiate between varies stages of caries progression. Caries diagnostic is thus assisted by radiographic imaging, which however, also has a limited sensitivity and requires the use of x-rays. While alternatives for caries imaging have been developed (e.g. quantitative laser or light fluorescence (QLF) or electrical conductance measurements (ECM)) no gold standard could be established so far highlighting the need for new save and sensitive imaging techniques.
Objective: To assess the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions over 24 months. In addition, the use of a SFE laser optical device for the assessment of caries lesions and their progression will be assessed in comparison to radiographic examination.
Materials and Methods: 50 volunteers (age 6-13 years) with at least 1 proximal early caries lesion in primary molars will be enrolled and randomly assigned to the resin infiltration and control groups. In the resin infiltration group early caries lesions will be treated using Icon (DMG), whereas the lesions in the control group will be managed using Oral Hygiene Instructions (OHI) and topical fluoridation (Duraphat Fluoride Varnish, Colgate). Lesion depth will be assessed through radiographic evaluation as well as through a novel optical device based on scanning fiber endoscope (SFE) technology for early caries detection through laser light imaging. SFE laser optical device prototypes developed by the University of Washington's Human Photonics Lab (HPL) will be utilized. Such a device is already in human use for applications such as imaging and cancer screening.
Clinical Significance: Resin infiltration of early caries lesions may be an effective therapeutic strategy in paediatric dentistry to reduce caries progression. Additionally, the SFE optical device may be suitable technology to visualize early caries lesions and their progression, which would offer a safe alternative to radiography for assessing and monitoring dental caries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Experimental | Device: Resin infiltrationEnrolled proximal early caries lesions will be treated using the resin infiltrant Icon (DMG, Germany). |
| Fluoride varnish & Oral hygiene instruction | Active comparator | Device: Fluoride varnish & Oral hygiene instructionOral hygiene instruction and topical fluoridation therapy (Duraphat Fluoride Varnish, Colgate, USA) will be provided. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 6-13 years
- Early caries lesions in primary molars (depth: E1 or E2)
- Good general health
- Available for 12 \& 24 months recalls
- Signed consent/assent/HIPAA
Key exclusion criteria (5 listed)
- Participation in other study
- History of adverse reaction on clinical material
- Sensitivity during screening test
- Poor access to teeth
- Patient refusing radiographic examination
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), approximal resin infiltration kitUp to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth, the study lesions will be treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions. Essentially, the treatment consists of the following parts: 1) isolating the tooth with a rubber dam and cleaning its surface; 2) removing/ conditioning the surface layer of the lesion (using Icon-Etch) to open the lesion body; 3) drying of the exposed porous enamel; 4) infiltrating the existing pore volume with the resin infiltrant (Icon Infiltrant); 5) light curing of the resin infiltrant; 6) repeating the infiltration step including light curing; followed by 7) finalizing using interproximal finishing/polishing strips. | Device | Resin infiltration |
| Fluoride varnish & Oral hygiene instructionAlso: Duraphat Fluoride Varnish (Colgate, USA)Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy will be provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) will be used according to manufactures´ instructions. | Device | Fluoride varnish & Oral hygiene instruction |
Primary outcome
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Time frame: 24 months
Change in categorical lesion depth (progression to next depth category lesion; E1->E2->D1->D2->filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).
2 secondary outcomes
Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging
Time frame: 0, 12 and 24 months
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15897335Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.
Related trials for Caries,Dental
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
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
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.
Joel Berg, DDS, MS principal investigator
The Center for Pediatric Dentistry
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 Fluoride varnish & Oral hygiene instruction in people with Caries,Dental, run by DMG Dental Material Gesellschaft mbH 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2023). 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 That Changed in Size (E1->E2->D1->D2-> Filling) (time frame: 24 months). 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 NCT01796106, 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 19 Jul 2023.