CompletedNot Applicable

Efficacy Evaluation of Two Different Fluoride Applications

Turkey (Türkiye)23 participantsStarted 2023-02-24

Plain-language 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.

Who can participate

Age range13 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: WSA

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta Q

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta R

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

Timeframe: 1 Month

Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

Timeframe: 1 Month

Measurement of White Spot Lesions by QLF Parameters: WSA

Timeframe: 1 Month

Trial details

NCT IDNCT06131294

SponsorIvoclar Vivadent AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-31

Results submitted2025-01-22

View on ClinicalTrials.gov More White Spot Lesion trials

Plain-language summary

Who can participate

Age range13 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: WSA

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta Q

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta R

Timeframe: Baseline

Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)

Timeframe: 1 Month

Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)

Timeframe: 1 Month

Measurement of White Spot Lesions by QLF Parameters: WSA

Timeframe: 1 Month