Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of a bonding agent to place the orthodontic appliance, Use of fluoride releasing bonding agent to place the orthodontic appliance.
- Who it may be relevant to
- Registry conditions: White Spot Lesions. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Potential of Fluoride Sealants in Preventing White Spot Lesions During Orthodontic Treatment
Overview
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
- 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.
Primary outcome measures
- Prevalence of white spot lesions [Time frame: 3 months]
Secondary outcome measures (1)
- Enamel Decalcification Index (EDI) [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07691879 · 22496815