Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients
White Spot Lesions
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 10 years - 17 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 40 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Study population
Healthy adolscents who are in need of orthodontic treatment.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Group Sealant
Side of the maxilla in which a fluoride releasing bonding agent was used
Other: Use of fluoride releasing bonding agent to place the orthodontic appliance
Control Group
Side of the maxilla in which a regular bonding agent was used
Other: Use of a bonding agent to place the orthodontic appliance
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
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Prevalence of white spot lesions
Time frame: 3 months
Not reported in this registry record.
Secondary measures
Enamel Decalcification Index (EDI)
Time frame: 3 months
Difference in EDI between the groups
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Sigmund Freud Dental ClinicVienna, AustriaRecruiting
Study team and timeline
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Study start
- Sep 1, 2026 Actual
- Primary completion
- Mar 1, 2027 Estimated
- Study completion
- May 1, 2027 Estimated
- First posted
- Jul 9, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026