Trial Outcomes & Findings for Clinical Evaluation of an Experimental Remineralization Product (NCT NCT06166849)
NCT ID: NCT06166849
Last Updated: 2026-03-27
Results Overview
Analysis of incipient caries or demineralized enamel by using laser fluorescence technology.
COMPLETED
NA
43 participants
Baseline to 1 Year
2026-03-27
Participant Flow
Unit of analysis: Lesions
Participant milestones
| Measure |
Experimental Fluoride Application
Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)
Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
|
Control Group
No Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
43 59
|
43 59
|
|
Overall Study
COMPLETED
|
39 51
|
39 54
|
|
Overall Study
NOT COMPLETED
|
4 8
|
4 5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Fluoride Application
n=59 Lesions
Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)
Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
|
Control Group
n=59 Lesions
No Treatment
|
Total
n=118 Lesions
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 18 years
|
0 participants
n=43 Participants
|
0 participants
n=43 Participants
|
0 participants
n=43 Participants
|
|
Age, Customized
Between 18 and 65 years
|
43 participants
n=43 Participants
|
43 participants
n=43 Participants
|
43 participants
n=43 Participants
|
|
Age, Customized
>= 65 years
|
0 participants
n=43 Participants
|
0 participants
n=43 Participants
|
0 participants
n=43 Participants
|
|
Sex/Gender, Customized
Female
|
33 participants
n=43 Participants
|
33 participants
n=43 Participants
|
33 participants
n=43 Participants
|
|
Sex/Gender, Customized
Male
|
10 participants
n=43 Participants
|
10 participants
n=43 Participants
|
10 participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline to 1 YearAnalysis of incipient caries or demineralized enamel by using laser fluorescence technology.
Outcome measures
| Measure |
Experimental Fluoride Application
n=51 Lesions
Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)
Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
|
Control Group
n=54 Lesions
No Treatment
|
|---|---|---|
|
White Spot Measurement
Improvement of White Spots
|
34 Lesions
|
37 Lesions
|
|
White Spot Measurement
No Changes in White Spots
|
1 Lesions
|
0 Lesions
|
|
White Spot Measurement
Deterioration of White Spots
|
16 Lesions
|
17 Lesions
|
PRIMARY outcome
Timeframe: Baseline to 1 YearEvaluation 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
Outcome measures
| Measure |
Experimental Fluoride Application
n=51 Lesions
Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application)
Experimental Fluoride Application: The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
|
Control Group
n=54 Lesions
No Treatment
|
|---|---|---|
|
ICDAS II Visual Scoring System (Codes)
Improvement of ICDAS Score
|
22 Lesions
|
18 Lesions
|
|
ICDAS II Visual Scoring System (Codes)
No Change in ICTAS Score
|
29 Lesions
|
36 Lesions
|
Adverse Events
Experimental Fluoride Application
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60