N/A N=46 Randomized Double-blind Treatment

Efficacy Evaluation of Two Different Fluoride Applications

White Spot Lesion

Bottom Line

View on ClinicalTrials.gov: NCT06131294 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Apr 2025

Primary outcome: Primary: Measurement of White Spot Lesions by QLF Parameters: Delta F (Max) — -28.2; -26.3 percent change (%)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fluoride Application (Experimental Fluoride Application) (Device); Fluor Protector S (Device)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Ivoclar Vivadent AG
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-22.6; -25.3	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.5; -11.6	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: WSA	346.4; 373.5	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta Q	-4819; -5692	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta R	20.7; 27.8	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-22.6; -25.3	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.5; -11.6	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: WSA	346.4; 373.5	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta Q	-4819; -5692	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta R	20.7; 27.8	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-22.6; -25.3	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.5; -11.6	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: WSA	346.4; 373.5	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta Q	-4819; -5692	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta R	20.7; 27.8	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)	-22.6; -25.3	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)	-10.5; -11.6	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: WSA	346.4; 373.5	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta Q	-4819; -5692	—
PRIMARY Measurement of White Spot Lesions by QLF Parameters: Delta R	20.7; 27.8	—
SECONDARY Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	0; 0; 28; 28; 0; 0	—
SECONDARY Severity and Activity of White Spot Lesions by Nyvad Criteria	0; 0; 28; 28; 0; 0	—
SECONDARY Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	14; 7; 13; 16; 1; 5	—
SECONDARY Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	22; 12; 5; 12; 1; 4	—
SECONDARY Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	14; 7; 13; 16; 1; 5	—
SECONDARY Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	22; 12; 5; 12; 1; 4	—
SECONDARY Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)	14; 7; 13; 16; 1; 5	—
SECONDARY Severity and Activity Transition of White Spot Lesions by Nyvad Criteria	22; 12; 5; 12; 1; 4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06131294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.