White Spot LesionsNCT07691879
Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients
An observational study of White Spot Lesions, run by Sigmund Freud PrivatUniversitat.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Use of a bonding agent to place the orthodontic appliance and Use of fluoride releasing bonding agent to place the orthodontic appliance
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy adolscents who are in need of orthodontic treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment
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:
Read more
- 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
- Being tested
- Use of a bonding agent to place the orthodontic appliance, Use of fluoride releasing bonding agent to place the orthodontic appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a bonding agent to place the orthodontic applianceOther
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 applianceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Sealant | Side of the maxilla in which a fluoride releasing bonding agent was used Receives: 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 Receives: Other: Use of a bonding agent to place the orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of white spot lesions
Measured: 3 months
Secondary outcomes (1)
Enamel Decalcification Index (EDI)
Difference in EDI between the groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Bertl, Professor, Study chair, Sigmund Freud Private University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691879
- Sponsor's protocol ID
- 22496815
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT07691879
- Acronym / sponsor ID
- 22496815
- Conditions
- White Spot Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Sealant | – | Other: Use of fluoride releasing bonding agent to place the orthodontic applianceSide of the maxilla in which a fluoride releasing bonding agent was used |
| Control Group | – | Other: Use of a bonding agent to place the orthodontic applianceSide of the maxilla in which a regular bonding agent was used |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy adolscents who are in need of orthodontic treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pre-existing white spot lesions
- Active carious lesions
- Structural enamel defects
- Systemic diseases affecting oral health
- Vestibular restorations in the anterior region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a bonding agent to place the orthodontic applianceIn 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 | Control Group |
| Use of fluoride releasing bonding agent to place the orthodontic applianceIn 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. | Other | Group Sealant |
Primary outcome
Prevalence of white spot lesions
Time frame: 3 months
1 secondary outcome
Enamel Decalcification Index (EDI)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for White Spot Lesions
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
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Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael H Bertl, Professor study chair
Sigmund Freud Private University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of White Spot Lesions, run by Sigmund Freud PrivatUniversitat.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Schwarz, DMD, PhD (+43 1 720 19 66, linda.schwarz@med.sfu.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of white spot lesions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.