Effects of Topical Fluoride in Orthodontic Patients

University of Verona

Status: Active, not recruiting

Conditions: Orthodontic Patients; Clinical Effect; Topical Fluoride; Antimicrobial Effect

Treatments: Device: Fluoride varnish; Device: Fluoride gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07091890

328CET

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

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

Experimental group

Treatment:

Device: Fluoride gel

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

Experimental group

Treatment:

Device: Fluoride varnish

Professional oral hygiene session alone

No Intervention group

Description:

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