Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients

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.

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Key information

Conditions

White Spot Lesions

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of a bonding agent to place the orthodontic appliance

Other

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.

Use of fluoride releasing bonding agent to place the orthodontic appliance

Other

Primary outcomes

Prevalence of white spot lesions

Time frame: 3 months

Secondary outcomes

Enamel Decalcification Index (EDI)

Time frame: 3 months

Difference in EDI between the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Schwarz, DMD, PhD

CONTACT

[email protected]

+43 1 720 19 66

Sponsors and collaborators

Lead sponsor

Sigmund Freud PrivatUniversitat

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 9, 2026
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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