White Spot LesionNCT06166849
Clinical Evaluation of an Experimental Remineralization Product
A study testing Experimental Fluoride Application in people with White Spot Lesion, run by Ivoclar Vivadent AG at 1 site in Romania.
Trial summary
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Experimental Fluoride Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteRomania
- Study dates
- 28 Mar 2023to 11 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
- Active caries lesion
- Patient at risk of caries
- Vital teeth
Who cannot join
- Pregnancy
- Enamel detachment at the site of investigation
- Allergies (DoReMin)
- Chronic diseases
Trial locations and contacts
1 site in 1 country.
Romania1 site
Iuliu Hatieganu, University of Medicine and Pharmacy
Cluj-Napoca, 400012
About this study
Official title: Clinical Study of Tooth Enamel Remineralization Using DoReMin Product
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
- Conditions
- White Spot Lesion
- Being tested
- Experimental Fluoride Application
- Keywords
- white spot lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Fluoride ApplicationDevice
The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Fluoride Application | Experimental | Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) Receives: Device: Experimental Fluoride Application |
| Control Group | No intervention | No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Spot Measurement
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
Measured: Baseline to 1 Year
ICDAS II Visual Scoring System (Codes)
Evaluation of the clinical status of the lesions:
0: Sound tooth surface: No evidence of caries after 5 sec air drying
- First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying
- Distinct visual change in enamel visible when wet, lesion must be visible when dry
- Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying
- Underlying dark shadow from dentin
- Distinct cavity with visible dentin
- Extensive (more than half the surface) distinct cavity with visible dentin
Measured: Baseline to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start28 Mar 2023
- Primary completion31 May 2024
- Study completion11 Mar 2025
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 White Spot LesionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Responsible party
- Sponsor
- Investigators
- Ada Delean, Prof. Dr., Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166849
- Sponsor's protocol ID
- LL4182693
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2023
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Tooth Enamel Remineralization Using DoReMin Product
- ClinicalTrials.gov ID
- NCT06166849
- Acronym / sponsor ID
- LL4182693
- Conditions
- White Spot Lesion
- Keywords
- white spot lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Fluoride Application | Experimental | Device: Experimental Fluoride ApplicationTwo-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) |
| Control Group | No intervention | –No Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
- Active caries lesion
- Patient at risk of caries
- Vital teeth
Key exclusion criteria (4 listed)
- Pregnancy
- Enamel detachment at the site of investigation
- Allergies (DoReMin)
- Chronic diseases
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 |
|---|---|---|
| Experimental Fluoride ApplicationThe two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions | Device | Experimental Fluoride Application |
Primary outcome
White Spot Measurement
Time frame: Baseline to 1 Year
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
ICDAS II Visual Scoring System (Codes)
Time frame: Baseline to 1 Year
Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying 1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentin 5. Distinct cavity with visible dentin 6. Extensive (more than half the surface) distinct cavity with visible dentin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
Ada Delean, Prof. Dr. principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Fluoride Application in people with White Spot Lesion, run by Ivoclar Vivadent AG at 1 site in Romania.
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 4 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 27 Mar 2026. 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 Romania. 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 27 Mar 2026). 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?
White Spot Measurement (time frame: Baseline to 1 Year). The study lists 2 primary outcomes in all. 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 27 Mar 2026.