Topical FluorideNCT07091890
Effects of Topical Fluoride in Orthodontic Patients
A study testing Fluoride gel and Fluoride varnish in people with Topical Fluoride and Orthodontic Patients, run by Universita di Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Topical Fluoride, Orthodontic Patients, Antimicrobial Effect
- What is being tested?
- Fluoride gel and Fluoride varnish
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1 < DMFT < n-1 (n= number of teeth present in the oral cavity)
- age between 8 and 17 years
- patient wearing fixed orthodontic appliances
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Microbiology and Clinical Efficacy of Professional Topical Fluoride on Streptococcus Mutans and Selemonas Sputigena in Orthodontic Patients: a Randomized Clinical Trial
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%).
Read more
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.
- Being tested
- Fluoride gel, Fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride gelDevice
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
Fluoride varnishDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel | Experimental | Not described Receives: Device: Fluoride gel |
| Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish | Experimental | Not described Receives: Device: Fluoride varnish |
| Professional oral hygiene session alone | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative evaluation of Streptococcus mutans
Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)
Measured: T0 baseline, T1 4 months
Quantitative evaluation of Selemonas sputigena
Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)
Measured: T0 baseline, T1 4 months
Secondary outcomes (3)
Plaque Control Record
The Plaque Control Record (%) indicates the percentage of the tooth surface covered by bacterial plaque. The percentage was calculated by dividing the number of tooth surfaces with plaque by the number of areas examined and then multiplying the result by 100. Four surfaces were examined for each tooth: buccal, lingual/palatal, mesial, and distal surfaces. The highest value is 100% and it means that plaque is present on all the surfaces.
Measured: T0 baseline, T1 4 months
DMFT
The DMFT is a caries prevalence index that refers to the presence of Decayed, Missing, Filled Teeth due to caries (Decayed, Missing, Filled Teeth). The individual value for the patient is the sum of D+M+F. The highest score is 32 and it shows the greatest value for this index.
Measured: T0 baseline, T1 4 months
Salivary ph
To assess salivary pH, a specific pH reagent strip was moistened with the patient's saliva. After an appropriate waiting period, as indicated by the manufacturer of the saliva test, the color displayed by the strip was compared to that on the reference scale to read the result. The scale of pH is: <6,5 acid; 6,5-7,5 neutral; >7,5 alkaline.
Measured: T0 baseline, T1 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start16 Nov 2023
- Primary completion30 Jun 2025
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Topical FluorideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Pardo, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091890
- Sponsor's protocol ID
- 328CET
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology and Clinical Efficacy of Professional Topical Fluoride on Streptococcus Mutans and Selemonas Sputigena in Orthodontic Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07091890
- Acronym / sponsor ID
- 328CET
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel | Experimental | Device: Fluoride gel |
| Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish | Experimental | Device: Fluoride varnish |
| Professional oral hygiene session alone | No intervention | –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 |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1 < DMFT < n-1 (n= number of teeth present in the oral cavity)
- age between 8 and 17 years
- patient wearing fixed orthodontic appliances
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride gelAfter 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 | Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel |
| Fluoride varnishAfter 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. | Device | Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish |
Primary outcome
Quantitative evaluation of Streptococcus mutans
Time frame: T0 baseline, T1 4 months
Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)
Quantitative evaluation of Selemonas sputigena
Time frame: T0 baseline, T1 4 months
Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)
3 secondary outcomes
Plaque Control Record
Time frame: T0 baseline, T1 4 months
DMFT
Time frame: T0 baseline, T1 4 months
Salivary ph
Time frame: T0 baseline, T1 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride gel and Fluoride varnish in people with Topical Fluoride and Orthodontic Patients, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative evaluation of Streptococcus mutans (time frame: T0 baseline, T1 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.