Clinical trial Recruiting at 1 site Observational Ages 10 to 17

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.

More White Spot Lesions [Initial Caries] on Smooth Surface of Tooth trials

Quick facts

Study typeObservational
Ages10 Years to 17 Years
SexAll
Enrollment40 (estimated)
SponsorSigmund Freud PrivatUniversitat
Academic / other
Locations1 site (Vienna)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedMarch 1, 2027
Study endsMay 1, 2027
Registry record updatedNovember 10, 2026
Trial IDNCT07691879 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.