N/A
Completed N=86
Clinical Evaluation of an Experimental Remineralization Product
White Spot Lesion
Source: ClinicalTrials.gov NCT06166849 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: White Spot Measurement — 34; 37; 1; 0 Lesions
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY White Spot Measurement |
34; 37; 1; 0; 16; 17 | — |
| PRIMARY ICDAS II Visual Scoring System (Codes) |
22; 18; 29; 36 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy
- Enamel detachment at the site of investigation
- Allergies (DoReMin)
- Chronic diseases
Data sourced from ClinicalTrials.gov (NCT06166849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.