Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients

ConditionWhite Spot Lesions

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age10-17

SponsorSigmund Freud PrivatUniversitat

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pre-existing white spot lesions

Active carious lesions

Structural enamel defects

Systemic diseases affecting oral health

Trial population

Healthy adolscents who are in need of orthodontic treatment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Use of a bonding agent to place the orthodontic appliance
Other intervention
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 intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Group Sealant1 intervention

Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

Prevalence of white spot lesions

Time frame

3 months

Secondary outcomes

Enamel Decalcification Index (EDI)

Difference in EDI between the groups

Time frame

3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sigmund Freud PrivatUniversitat

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: