Efficacy Evaluation of Two Different Fluoride Applications

Not Applicable

Completed

Conditions: White Spot Lesion

Interventions: Device: Fluor Protector S
Device: Fluoride Application (Experimental Fluoride Application)

Registration Number: NCT06131294

Lead Sponsor: Ivoclar Vivadent AG

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluor Protector S	Fluor Protector S	The ammonium fluoride gel will be applied once on the white spot lesions.
Expermental Fluoride Application	Fluoride Application (Experimental Fluoride Application)	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.

Primary Outcome Measures

Name	Time	Method
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	12 Month	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	12 Month	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: WSA	12 Month	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - white spot area (WSA)
Measurement of White Spot Lesions by QLF Parameters: Delta Q	12 Month	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q - delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)
Measurement of White Spot Lesions by QLF Parameters: Delta R	12 Month	Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: - delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)

Secondary Outcome Measures

Name	Time	Method
Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	Baseline	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
Severity and Activity of White Spot Lesions by Nyvad Criteria	Baseline	Evaluation of the clinical status of the lesions: 0: Sound 1. Active caries (intact surface) 2. Active caries (surface discontinuity) 3. Active caries (cavity) 4. Inactive caries (intact surface) 5. Inactive caries (surface discontinuity) 6. Inactive caries (cavity) 7. Filling (sound surface) 8. Filling+active caries 9. Filling+inactive caries
Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	Baseline to 12 month	Evaluation of the clinical status of the lesions: * "progression" = ICDAS score increased from 2 to 3 * "unchanged" = ICDAS score 2 * "regression" = ICDAS score decreased from 2 to 0 or 1
Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	Baseline to 12 month	Evaluation of the clinical status of the lesions: * "progression" = Nyvad score changed from 1 to 2 or 5 * "unchanged" = Nyvad score 1 * "regression" = Nyvad score changed from 1 to 0 or 4