Effects of Topical Fluoride in Orthodontic Patients

NCT ID: NCT07091890

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2025-11-30

Brief Summary

This study was born from the need to improve caries prevention in orthodontic patients, a group particularly at risk. Fixed orthodontic appliances make daily oral hygiene more difficult, leading to increased plaque accumulation and the proliferation of cariogenic bacteria such as Streptococcus mutans and, more recently, Selenomonas sputigena. Although the latter does not cause cavities on its own, it enhances the action of Streptococcus mutans, making the caries process more aggressive.

The aim of the research was to evaluate the effectiveness of two different types of professional topical fluoride-gel and varnish-in reducing the presence of these bacteria and improving certain clinical parameters, such as salivary pH, the DMFT index (which measures decayed, missing, and filled teeth), and the Plaque Control Record (PCR%).

The study involved 45 patients, all between 8 and 17 years old and wearing fixed orthodontic appliances. They were divided into three groups: one received fluoride gel, another received fluoride varnish, and the third group underwent only a professional oral hygiene session, without any fluoride application. All patients were evaluated at the beginning of the study (T0) and again after four months (T1), both clinically and microbiologically, through saliva and plaque analysis.

The results showed that in the fluoride-treated groups-especially the varnish group-there was a significant reduction in plaque, an improvement in salivary pH (mainly in the gel group), and a decrease in the presence of S. mutans and S. sputigena. Furthermore, there was a reduction in oral Streptococci and Lactobacilli levels in the treated groups, whereas these levels increased in the control group. Interestingly, although not all differences were statistically significant, the improvements observed in the treatment groups suggest a clinically relevant benefit of topical fluoride, especially in varnish form.

In conclusion, professional application of fluoride-whether in gel or varnish form-proved effective in counteracting key bacteria responsible for dental caries in orthodontic patients and in improving several relevant clinical parameters. This confirms the importance of combining professional oral hygiene with specific fluoride treatments in patients wearing orthodontic appliances.

Conditions

Topical Fluoride; Orthodontic Patients; Antimicrobial Effect; Clinical Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel

Group Type: EXPERIMENTAL

Fluoride gel

Intervention Type: DEVICE

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

Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish

Group Type: EXPERIMENTAL

Fluoride varnish

Intervention Type: DEVICE

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.

Professional oral hygiene session alone

All patients underwent a professional oral hygiene session to remove bacterial plaque and calculus from the tooth surfaces. Bacterial plaque was removed using a supragingival air-polishing device that dispersed glycine powder. When calcified residues were present, a piezoelectric ultrasonic scaler with either a supragingival insert, perio-slim periodontal insert, or scaler was selectively used in cases of deposits in areas that were difficult to access

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1 < DMFT < n-1 (n= number of teeth present in the oral cavity)
• age between 8 and 17 years
• patient wearing fixed orthodontic appliances

Exclusion Criteria

• DMFT = 0 *; professional topical fluoride prophylaxis session carried out in the last 3 months
• patient not wearing fixed orthodontic appliances
• orthodontic treatment already completed or not started * DMFT refers to a caries prevalence index related to the presence of Decayed, Missing, Filled Teeth due to caries (Decayed, Missing, Filled Teeth).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Alessia Pardo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Integrated University Hospital Company Verona

Verona, , Italy

Countries

Italy

Other Identifiers

328CET

Identifier Type: -

Identifier Source: org_study_id