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Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients

NCT07691879 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-09

No results posted yet for this study

Summary

The aim of this trial is to investigate the potential of using an adhesive bonding agent that also acts as a fluoride sealant when placing fixed orthodontic appliances in adolescent patients, as an alternative to regular bonding agents.

The main question it aims to answer is:

\- Does an adhesive fluoride sealant reduce the prevalence of white spot lesions in orthodontic adolescent patients after an observation period of 3 months?

Participants who need orthodontic treatment and who agree to take part in this study will have their orthodontic appliance placed using regular adhesive on one side of their upper jaw and fluoride sealant on the other.

White spot lesion prevalence will be assessed using the Enamel Decalcification Index (EDI) at baseline and after 3 months.

Conditions

  • White Spot Lesions

Interventions

OTHER

Use of a bonding agent to place the orthodontic appliance

In this prospective study using the split-mouth design, patients will be followed for 3 months after placing the fixed orthodontic appliance. The orthodontic appliance will be placed according to the clinic's standards using an adhesive especially provided for this purpose.

OTHER

Use of fluoride releasing bonding agent to place the orthodontic appliance

In this prospective study using the split-mouth design, patients will be followed for 3 months after placing the fixed orthodontic appliance. The orthodontic appliance will be placed according to the clinic's standards using an adhesive bondin agent that simultaneously works as a fluoride sealant especially provided for this purpose.

Sponsors & Collaborators

  • Sigmund Freud PrivatUniversitat

    lead OTHER

Principal Investigators

  • Michael H Bertl, Professor · Sigmund Freud Private University, Faculty of Medicine

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-03-01
Completion
2027-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691879 on ClinicalTrials.gov