Clinical Evaluation of an Experimental Remineralization Product

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of Tooth Enamel Remineralization Using DoReMin Product

Conditions
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White Spot Lesion

Intervention / Treatment
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* Device: Experimental Fluoride Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Fluoride Application<br>Two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application) | Device: Experimental Fluoride Application<br>* The two-step system, consisting of Component A and Component B, will be applied once on the white spot lesions<br>|
| No Intervention: No Treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Spot Measurement | Analysis of incipient caries or demineralized enamel by using laser fluorescence technology. | 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 | Baseline to 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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white spot lesion