CariesNCT01988337
Lesion Progression After Icon Treatment in Young Adults
A study testing Resin infiltration and Mock treatment in people with Caries and Salivary Function, run by DMG Dental Material Gesellschaft mbH at 1 site in United States.
Trial summary
This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries, Salivary Function, Tooth Sensitivity
- What is being tested?
- Resin infiltration and Mock treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be age 19 years and older
- Have at least two vital carious teeth with caries ranging from enamel to just into dentin.
- If the lesion is not on a 3rd molar
- If the lesion is not developmental.
- If the lesion is not cavitated
- Be a regular dental attendee able to return for assessments
Show all 13Show fewer
- Be in good medical health and able to tolerate the dental procedure
- Have no chronic periodontitis which could compromise tooth retention.
- Have normal salivary function.
- Have normal bone levels
- No lingering cold sensitivity
- No periapical sensitivity
- No sensitivity to percussion
Who cannot join
- Do not meet the inclusion criteria
- Are not able to tolerate the time required for the study
- There is a history of an adverse reaction to any materials used in the study
- They are irregular dental attendees
- They maintain an unacceptable standard of oral hygiene.
- They have chronic periodontitis
- There is severe salivary gland dysfunction or reduced salivary flow is observed
- They are unable to return for recall appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomized Controlled Clinical Trial of Lesion Progression After Treatment With Icon vs. Placebo in Caries Lesions in Young Adults Over 36 Months
This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon, Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The study is designed as a randomized, controlled, prospective clinical trial with a three year follow-up evaluation period.
The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2 study lesions. The patients will be evaluated at six time points over a period of 3 years. Lesion status and caries risk will be monitored at 6-month intervals, while radiographic evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.
Read the detailed description
Introduction Dental caries is the most widespread of all diseases. It causes destruction of tooth structure by dissolving the enamel on the outside of the tooth first and then progressing into the inside of the tooth. While it is possible to use traditional dental fillings to replace diseased tooth structure, it is far better to slow down or reverse the disease process so that no fillings are needed. One of the most difficult places to use preventive or non-surgical treatment is the contact area between teeth. Recently there is evolving interest in using composites to infiltrate enamel and dentin areas that have just begun to be destroyed by caries. The infiltration technique arrests the lesion progression by sealing the porous surface and restores the damage avoiding ongoing acidic damage of tooth structure.
Objective Assess the clinical efficacy s of using Icon to infiltrate initial lesions below the tooth surfaces that exist on the contact surfaces between posterior teeth as a means of stabilizing diseased tooth structure and arresting further lesion development.
Materials and Methods One hundred fifty volunteers (19+ years) with two early lesions in posterior teeth will be enrolled into a clinical trial to evaluate the clinical efficacy of infiltrating the lesions as compared to current watch-and-wait approaches that are combined with good oral hygiene and fluoride application. Each subject will have a treated lesion and a control lesion. Only small early lesions without clinical signs of surface cavitation will be selected. The control lesions will be stabilized through a normal preventive regimen, while the treatment lesions will be infiltrated with a resin. Lesion status will be monitored every six months by clinical examination and as well using annual radiographs.
Clinical Significance Infiltrating a caries lesion is a potential effective strategy to strengthen damaged tooth structure and to reduce caries progression without any surgical intervention.
- Conditions
- Caries, Salivary Function, Tooth Sensitivity
- Being tested
- Resin infiltration, Mock treatment
- Keywords
- Icon
- Medical subject headings
- Dentin Sensitivity
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
The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.
Mock treatmentOther
For the mock treatment the procedure will be identical to the "Resin Infiltration" intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material.
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration | Experimental | One proximal caries lesion (split mouth design) per patient will be treated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions. Receives: Device: Resin infiltration |
| Mock treatment | Sham comparator | A second proximal caries lesion of each patient (split mouth design) will receive a placebo treatment to mimic "resin infiltration". Receives: Other: Mock treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Invasive Interventions (Fillings)
Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up).
Measured: 3 years
Secondary outcomes (1)
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). Reference: Anusavice K. Present and future approaches for the control of caries. J Dent Educ. 2005;69(5):538-854.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Slower than expected tooth decay in placebo group and insufficient recruitment.
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.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nate O. Lawson, Principal investigator, Birmingham, Alabama 35294; US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988337
- Sponsor's protocol ID
- TOPIC36
- Status last verified
- Sep 2022
- First submitted
- 7 Nov 2013
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Clinical Trial of Lesion Progression After Treatment With Icon vs. Placebo in Caries Lesions in Young Adults Over 36 Months
- ClinicalTrials.gov ID
- NCT01988337
- Acronym / sponsor ID
- TOPIC36
- Conditions
- Caries, Salivary Function, Tooth Sensitivity
- Keywords
- Icon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than expected tooth decay in placebo group and insufficient recruitment.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 4 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon, Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The study is designed as a randomized, controlled, prospective clinical trial with a three year follow-up evaluation period.
The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2 study lesions. The patients will be evaluated at six time points over a period of 3 years. Lesion status and caries risk will be monitored at 6-month intervals, while radiographic evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.
Detailed description
Introduction Dental caries is the most widespread of all diseases. It causes destruction of tooth structure by dissolving the enamel on the outside of the tooth first and then progressing into the inside of the tooth. While it is possible to use traditional dental fillings to replace diseased tooth structure, it is far better to slow down or reverse the disease process so that no fillings are needed. One of the most difficult places to use preventive or non-surgical treatment is the contact area between teeth. Recently there is evolving interest in using composites to infiltrate enamel and dentin areas that have just begun to be destroyed by caries. The infiltration technique arrests the lesion progression by sealing the porous surface and restores the damage avoiding ongoing acidic damage of tooth structure.
Objective Assess the clinical efficacy s of using Icon to infiltrate initial lesions below the tooth surfaces that exist on the contact surfaces between posterior teeth as a means of stabilizing diseased tooth structure and arresting further lesion development.
Materials and Methods One hundred fifty volunteers (19+ years) with two early lesions in posterior teeth will be enrolled into a clinical trial to evaluate the clinical efficacy of infiltrating the lesions as compared to current watch-and-wait approaches that are combined with good oral hygiene and fluoride application. Each subject will have a treated lesion and a control lesion. Only small early lesions without clinical signs of surface cavitation will be selected. The control lesions will be stabilized through a normal preventive regimen, while the treatment lesions will be infiltrated with a resin. Lesion status will be monitored every six months by clinical examination and as well using annual radiographs.
Clinical Significance Infiltrating a caries lesion is a potential effective strategy to strengthen damaged tooth structure and to reduce caries progression without any surgical intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Experimental | Device: Resin infiltrationOne proximal caries lesion (split mouth design) per patient will be treated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions. |
| Mock treatment | Sham comparator | Other: Mock treatmentA second proximal caries lesion of each patient (split mouth design) will receive a placebo treatment to mimic "resin infiltration". |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be age 19 years and older
- Have at least two vital carious teeth with caries ranging from enamel to just into dentin.
- Be a regular dental attendee able to return for assessments
- Be in good medical health and able to tolerate the dental procedure
- Have no chronic periodontitis which could compromise tooth retention.
Key exclusion criteria (8 listed)
- Do not meet the inclusion criteria
- Are not able to tolerate the time required for the study
- There is a history of an adverse reaction to any materials used in the study
- They are irregular dental attendees
- They maintain an unacceptable standard of oral hygiene.
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 kitThe study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first. | Device | Resin infiltration |
| Mock treatmentFor the mock treatment the procedure will be identical to the "Resin Infiltration" intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material. | Other | Mock treatment |
Primary outcome
Number of Invasive Interventions (Fillings)
Time frame: 3 years
Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up).
1 secondary outcome
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Time frame: 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nate O. Lawson principal investigator
Birmingham, Alabama 35294; US
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 Mock treatment in people with Caries and Salivary Function, 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 13 inclusion and 8 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 4 Oct 2022. 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 4 Oct 2022). 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 Invasive Interventions (Fillings) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.