White Spot Lesion
Conditions
Keywords
white spot lesion
Brief 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.
Interventions
DEVICEExperimental Fluoride Application
The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions
Sponsors
Ivoclar Vivadent AG
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White Spot Measurement | Baseline to 1 Year | Analysis of incipient caries or demineralized enamel by using laser fluorescence technology. |
| ICDAS II Visual Scoring System (Codes) | 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 |
Countries
Romania
Contacts
PRINCIPAL_INVESTIGATORAda Delean, Prof. Dr.
Iuliu Hatieganu University of Medicine and Pharmacy
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized <= 18 years | 0 participants |
| Age, Customized >= 65 years | 0 participants |
| Age, Customized Between 18 and 65 years | 43 participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex/Gender, Customized Female | 33 participants |
| Sex/Gender, Customized Male | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
None listed