Preventive Potential of Fluoride Sealants in Adolescent Orthodontic Patients

NCT07691879 | Not Yet Recruiting

• 1 other identifier: 22496815
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

White Spot Lesions

Outcome Measures

Primary Outcomes (1)

• Prevalence of white spot lesions

  3 months

Secondary Outcomes (1)

• Enamel Decalcification Index (EDI)

  3 months

Study Arms (2)

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

Interventions

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.

Control Group

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.

Group Sealant

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy adolscents who are in need of orthodontic treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigmund Freud PrivatUniversitat: lead

Study Officials

• Michael H Bertl, Professor

  Sigmund Freud Private University, Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Linda Schwarz, DMD, PhD

CONTACT

+43 1 720 19 66; linda.schwarz@med.sfu.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-06