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Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients

The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07691879
Enrollment
40
Registered
2026-07-09
Start date
2026-09-01
Completion date
2027-05-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

Brief 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.

Interventions

OTHERUse 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.

OTHERUse 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

Sigmund Freud PrivatUniversitat
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Prevalence of white spot lesions3 months

Secondary

MeasureTime frameDescription
Enamel Decalcification Index (EDI)3 monthsDifference in EDI between the groups

Contacts

CONTACTLinda Schwarz, DMD, PhD
linda.schwarz@med.sfu.ac.at+43 1 720 19 66
STUDY_CHAIRMichael H Bertl, Professor

Sigmund Freud Private University, Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026