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 range

13 Years – 50 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

13 Years – 50 Years

Sex

ALL

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