Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients
Official title: The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment
Run by Sigmund Freud PrivatUniversitat · NCT07691879 · Data updated 2026-11-12
In teens getting braces, this study tests whether a fluoride-releasing bonding agent on one side of the upper jaw can reduce white spots compared with the regular bonding agent used on the other side after 3 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 17 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Sigmund Freud PrivatUniversitat Academic / other |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07691879 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 10–17 starting fixed orthodontic treatment in the upper jaw, with all upper teeth 15–25, and who have consent from themselves and a guardian.
✕Probably not a fit
Patients with pre-existing white spot lesions, active caries, enamel defects, systemic diseases affecting oral health, anterior vestibular restorations, or a high Little’s Index may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares two bonding approaches in adolescents starting fixed orthodontic treatment in the upper jaw. Each participant receives a fluoride-releasing adhesive on one side and a standard adhesive on the other, with white spot lesions assessed at baseline and after three months using the Enamel Decalcification Index. The aim is to see if the fluoride sealant can lower the prevalence of white spots during early orthodontic treatment. Participants must be 10–17 years old, have all upper teeth 15–25, and provide consent. Outcomes will inform whether fluoride-releasing bonding agents offer a preventive benefit against demineralization during orthodontic care.
Why it matters
Potential benefit: If successful, patients could experience fewer white spots around braces, improving long-term enamel health.
How similar studies have gone: Previous studies in fluoride-releasing bonding concepts have shown potential for reducing demineralization, but results are variable and this exact left-right comparative design is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age between 10 and 17 years * Initiation of fixed orthodontic treatment in the upper jaw * Presence of all teeth 15-25 * Written consent from patients and legal guardians Exclusion Criteria * Pre-existing white spot lesions * Active carious lesions * Structural enamel defects * Systemic diseases affecting oral health * Vestibular restorations in the anterior region * Little Index \> 9
Where it's running
-
Sigmund Freud Dental Clinic
Vienna, Austria Recruiting
Study contacts
- Study coordinator: Linda Schwarz, DMD, PhD
- Email: linda.schwarz@med.sfu.ac.at
- Phone: +43 1 720 19 66
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two treatments for white spot lesions after braces
This study is testing whether MI Paste Plus or resin infiltration works better to treat white spot lesions on teeth in young people who have just had their braces removed.
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Biomin fluoride varnish vs. Duraphat, with or without diode laser, for white spot lesions in primary teeth
This trial tests whether Biomin fluoride varnish, alone or with diode laser, can better remineralize white spot lesions in young children than standard Duraphat varnish.
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Epinamel Gel for Rebuilding White Spot Lesions Around Braces
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This study follows teens starting orthodontic treatment to see how their mouth bacteria and saliva proteins change over time.
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Remineralizing White Spot Lesions with P11-4: A three-arm trial
This trial tests whether applying the self-assembling peptide P11-4, alone or with fluoride varnish, can remineralize white spot lesions on permanent teeth in teens.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.