Effects of Topical Fluoride in Orthodontic Patients

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

November 30, 2025

Conditions
Topical FluorideOrthodontic PatientsAntimicrobial EffectClinical Effect
Interventions
DEVICE

Fluoride gel

After non-surgical therapy, 6-8 g of a gel containing 12,500 ppm of fluoride was applied for 4 min using a disposable tray appropriately sized for the patient's mouth. As per the guidelines, the patient was asked to briefly rinse their mouth with water. The aim was to remineralize the dental enamel to make it less susceptible to acid attacks caused by low salivary pH and the byproducts of bacterial metabolism

DEVICE

Fluoride varnish

After non-surgical therapy, a fluoride varnish containing 7,700 ppm of fluoride in a homogeneous solution was evenly distributed over the dental surfaces using a micro-brush. Patients were instructed to spit out excess saliva but not to rinse their mouth with water, and to refrain from eating or drinking for at least 60 min afterward. After drying, the varnish formed a fluoride-rich layer on the enamel, increasing the concentration by up to four times. Despite the high concentration of fluoride, the resin component of the varnish allowed for a slow, controlled release of fluoride over time, thus preventing its immediate loss and minimizing the amount ingested by the patient. The purpose was to prevent mineral loss from the enamel and promote its restoration, making the dental tissue more resistant to the acidic pH of saliva caused by the production of organic acids through bacterial metabolism.

Trial Locations (1)

37134

Integrated University Hospital Company Verona, Verona

All Listed Sponsors
lead

Universita di Verona

OTHER

NCT07091890 - Effects of Topical Fluoride in Orthodontic Patients | Biotech Hunter | Biotech Hunter