Fluoride Varnishes for Dental White Spots

Overseen By Tyler A Brennan, DDS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Antibiotics

Disqualifiers: Advanced periodontal disease, xerostomia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome. Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study: Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antibiotics or other drugs that might affect the study within 30 days before screening.

What data supports the effectiveness of the treatment for dental white spots?

Research shows that fluoride varnishes, including those with sodium fluoride, are effective in preventing enamel softening and promoting remineralization of teeth. Studies have demonstrated that these varnishes can significantly reduce mineral loss and improve the resistance of teeth to acid, which helps in treating white spots. ^{1 2 3 4 5}

Is fluoride varnish safe for humans?

Fluoride varnishes, including those with 5% sodium fluoride, have been used in studies with children and have shown no significant safety concerns. They are generally considered safe for human use, especially in dental applications. ^{2 4 6 7 8}

How does fluoride varnish treatment for dental white spots differ from other treatments?

Fluoride varnish is unique because it not only helps prevent cavities by strengthening tooth enamel but also has superior anti-demineralization effects, especially when combined with sodium fluoride, compared to other varnishes. It is applied directly to the teeth, making it a simple and effective option for treating white spots. ^{1 3 9 10 11}

Research Team

Renate Lux, PhD

Principal Investigator

University of California, Los Angeles

Tyler Brennan, DDS

Principal Investigator

University of California, Los Angeles

Nini Tran, DDS, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This study is for healthy teens aged 12-17 nearing the end of orthodontic treatment with metal braces and having at least two white spot lesions on their teeth. They must use only standard oral care products, agree to specific dental cleaning schedules, and follow diet instructions throughout the study.

Inclusion Criteria

I am between 12 and 17 years old.

I agree to use only a manual toothbrush and sodium fluoride toothpaste during the study.

I am willing to delay dental cleanings until the study's end.

Exclusion Criteria

I have severe gum disease.

I haven't taken any antibiotics or drugs that could affect the study in the last 30 days.

Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied

1 day

1 visit (in-person)

Treatment

Participants receive varnish treatments and assessments at 30, 90, and 180 days

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 5% Sodium Fluoride Varnish
• Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish

Trial Overview The trial tests how effective different fluoride varnishes are in treating white spots on teeth after braces. It's a split-mouth design where each participant gets different treatments on either side of their mouth, comparing placebo, sodium fluoride varnish, and resin-modified glass ionomer varnish.

Participant Groups

Group I: Placebo Varnish/Extended Contact RMGI Varnish Experimental Treatment 1 Intervention

This group will receive placebo varnish on their upper left and lower right teeth, and extended contact (XT) varnish on their upper right and lower left teeth.

Group II: Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish Experimental Treatment 2 Interventions

This group will receive extended contact (XT) varnish on their upper left and lower right teeth, and traditional 5% sodium fluoride varnish on their upper right and lower left teeth.

Group III: 5% Sodium Fluoride Varnish/Placebo Varnish Active Control 1 Intervention

This group will receive traditional 5% sodium fluoride varnish on their upper left and lower right teeth, and placebo varnish on their upper right and lower left teeth.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

The study tested the anti-demineralization effects of various varnishes on bovine root specimens, finding that S-PRG filler-containing varnishes, particularly those with sodium fluoride, significantly reduced mineral loss compared to a control varnish.

Among the tested varnishes, the PRG varnish II with sodium fluoride showed the best performance in preventing demineralization, indicating its potential effectiveness in dental applications for protecting root dentin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-demineralization characteristics of surface pre-reacted glass-ionomer (S-PRG) filler-containing varnishes. Shiiya, T., Kataoka, A., Tomiyama, K., et al.[2021]

The resin-modified glass-ionomer cement (RMGIC) Fuji II LC released equivalent or greater amounts of fluoride compared to two conventional cements (HiDense and KetacSilver) over a long-term period of 2.7 years, indicating its potential effectiveness in preventing tooth decay.

Unlike the conventional cements, the RMGIC maintained stable color over the study period, suggesting better aesthetic durability, while both acid-base cements showed noticeable color changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A long term study of fluoride release from metal-containing conventional and resin-modified glass-ionomer cements. Williams, JA., Billington, RW., Pearson, GJ.[2019]

In a study involving 44 children aged 3 to 5 with active white spot lesions, MI Varnish® showed a significantly greater reduction in active lesions compared to Duraphat Varnish® after 18 weeks.

At the 30-week follow-up, MI Varnish® also demonstrated a significant improvement in DIAGNOdent™ scores, indicating better remineralization of white spot lesions than the sodium fluoride varnish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Mekky, AI., Dowidar, KML., Talaat, DM.[2021]

In a study involving 138 children aged 11-13, semi-annual applications of sodium fluoride varnish (Duraphat) resulted in a significant reduction in dental caries compared to the control side, with a 24% reduction in caries increments.

The silane fluoride varnish (Fluor Protector) also showed benefits, with a 35% reduction in caries when compared to the control side, indicating that fluoride varnishes can provide additional protection even in areas with optimal fluoride exposure from drinking water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. Seppä, L., Tuutti, H., Luoma, H.[2019]

In a study involving 120 slabs of non-carious human enamel, fluoride treatments significantly prevented enamel softening compared to untreated controls, indicating their efficacy in remineralization.

Sodium fluoride varnishes, particularly with three applications of 2.3% Duraphat, were more effective than a 0.1% NaF solution, suggesting that the number of applications is more important for enamel protection than just the fluoride concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a sodium fluoride solution and a varnish with different fluoride concentrations on enamel remineralization in vitro. Seppä, L.[2019]

The study found that certain resin-based materials, particularly UniFil S and Beautifil, released significantly more fluoride in acidic conditions compared to water, indicating their potential effectiveness in combating dental decay in acidic environments.

While most materials showed some ability to neutralize acidity, this ability decreased over time, except for the resin-modified glass-ionomer cement (Fuji II LC), suggesting that the longevity of fluoride release and neutralization varies among different materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride release and neutralizing effect by resin-based materials. Itota, T., Al-Naimi, OT., Carrick, TE., et al.[2022]

The study found that varnishes containing higher concentrations of sodium fluoride (NaF) and sodium trimetaphosphate (TMP) released more fluoride and TMP into artificial saliva, with the highest release observed from varnishes with 5% NaF and 5% TMP.

However, combining NaF and TMP in varnishes significantly decreased the overall release of both fluoride and TMP, suggesting that their simultaneous use may limit their effectiveness in delivering these compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride and sodium trimetaphosphate (TMP) release from fluoride varnishes supplemented with TMP. Manarelli, MM., Delbem, AC., Percinoto, C., et al.[2016]

The new paste-liquid resin-modified glass ionomer (RMGI) effectively reduces fluid flow through human dentin, similar to an established adhesive, indicating its potential for relieving root sensitivity.

Both the RMGI and the adhesive demonstrated excellent sealing capabilities on dentin, whether the tubules were open or occluded, suggesting they can provide effective protection against sensitivity in dental applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a new desensitizing material on human dentin permeability. Rusin, RP., Agee, K., Suchko, M., et al.[2022]

A noncontact application of a 5% sodium fluoride varnish significantly improved the surface microhardness of white spot lesions (WSLs) compared to a water control, indicating effective remineralization.

The treatment also reduced the porosity of WSLs, suggesting that this varnish can enhance the enamel's resistance to acid, which is beneficial for preventing cavities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noncontact remineralization of incipient lesions treated with a 5% sodium fluoride varnish in vitro. Karlinsey, RL., Mackey, AC., Dodge, LE., et al.[2014]

A study involving 399 parents in Jeddah, Saudi Arabia, revealed that many parents (65.3% of males and 47.4% of females) were unsure about the safety of fluoride varnish for their children, indicating a significant lack of awareness regarding this effective caries-prevention method.

The research found a strong correlation between parents' educational background and their knowledge of fluoride varnish, suggesting that improving education on fluoride could enhance awareness and promote its use in dental care for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Knowledge and Awareness of Fluoride Varnish Application on Their Children - A Cross-Sectional Study. Almehmadi, AH., Bannan, A., Ahmad, A., et al.[2022]

In an in vitro study involving 48 extracted human third molars, the application of fluoride-releasing varnish significantly reduced enamel demineralization around orthodontic brackets bonded with composite resin, showing a 35% reduction in lesion depth.

While the fluoride varnish did not prevent demineralization in RMGI-bonded teeth, both RMGI groups exhibited 50% smaller lesion depths compared to the composite resin group without varnish, suggesting RMGI may offer better protection against enamel damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fluoride varnish on demineralization adjacent to brackets bonded with RMGI cement. Schmit, JL., Staley, RN., Wefel, JS., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Anti-demineralization characteristics of surface pre-reacted glass-ionomer (S-PRG) filler-containing varnishes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A long term study of fluoride release from metal-containing conventional and resin-modified glass-ionomer cements. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. [2021]

4. Denmark pubmed.ncbi.nlm.nih.gov

A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

Effects of a sodium fluoride solution and a varnish with different fluoride concentrations on enamel remineralization in vitro. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Fluoride release and neutralizing effect by resin-based materials. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Fluoride and sodium trimetaphosphate (TMP) release from fluoride varnishes supplemented with TMP. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Effect of a new desensitizing material on human dentin permeability. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Noncontact remineralization of incipient lesions treated with a 5% sodium fluoride varnish in vitro. [2014]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Parental Knowledge and Awareness of Fluoride Varnish Application on Their Children - A Cross-Sectional Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of fluoride varnish on demineralization adjacent to brackets bonded with RMGI cement. [2019]