Efficacy Evaluation of Two Different Fluoride Applications

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology. Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.

Official Title
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Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial

Conditions
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White Spot Lesion

Intervention / Treatment
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* Device: Fluoride Application (Experimental Fluoride Application and Fluor Protector S)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants. Age between 13 and 50 years No untreated caries lesions or periodontal disease No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate Subjects claimed regular brushing at least twice a day Subjects had to agree to keep the scheduled recall appointments for at least 1 year. Exclusion Criteria: Inactive non-cavitated lesions (Nyvad Score 4) Lesions with microcavity, cavitation, chipping or discoloration Lesions at buccal side of the molars Lesions adjacent to restoration Developmental white spot lesions such as enamel hypoplasia Pregnancy

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 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
Interventional Model Description: Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expermental Fluoride Application<br>The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one. | Device: Fluoride Application (Experimental Fluoride Application and Fluor Protector S)<br>* Both Fluoride containing applications are used to treat white spot lesions. (for more information see Description Arms)<br>|
| Active Comparator: Fluor Protector S<br>The ammonium fluoride gel will be applied once on the white spot lesions. | Device: Fluoride Application (Experimental Fluoride Application and Fluor Protector S)<br>* Both Fluoride containing applications are used to treat white spot lesions. (for more information see Description Arms)<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 quantified results of delta F and delta R values (QLF technology). These values indicate the degree of demineralization. | Baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Nyvad criteria | Evaluation of the clinical status of the lesions: 0: Sound Active caries (intact surface) Active caries (surface discontinuity) Active caries (cavity) Inactive caries (intact surface) Inactive caries (surface discontinuity) Inactive caries (cavity) Filling (sound surface) Filling+active caries Filling+inactive caries X: Extracted because of caries Lost because of caries | 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