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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of different fluoride varnishes in treating white spots on teeth, an early sign of cavities. These spots often develop after using metal braces, which make it difficult to maintain oral hygiene. Participants will receive fluoride treatments on different sides of their mouth to compare effectiveness. This trial is ideal for teens completing their braces treatment who have noticeable white spots on their teeth.

As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding effective treatments for post-braces dental care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that fluoride varnishes are generally safe for dental treatments. The 5% sodium fluoride varnish effectively supports dental care, but it should not contact the eyes, as it can cause irritation. Swallowing it should also be avoided, as ingestion can be harmful.

Studies indicate that the resin-modified glass ionomer (RMGI) varnish slowly releases fluoride, helping to prevent tooth decay. These varnishes set quickly, enhancing safety by minimizing potential negative effects. Overall, both types of varnish are considered safe for dental use when applied properly. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for dental white spots because they offer potentially more targeted and effective solutions compared to traditional fluoride treatments. The extended contact RMGI varnish stands out because it stays on the teeth longer, potentially enhancing its ability to strengthen enamel and reduce white spots. Additionally, the combination of 5% sodium fluoride varnish with the extended contact approach could provide a dual-action benefit, addressing white spots more efficiently. These new approaches are anticipated to enhance the effectiveness of treatment by either prolonging contact time with the teeth or by combining proven fluoride benefits with innovative application techniques.

What evidence suggests that this trial's treatments could be effective for dental white spots?

This trial will evaluate the effectiveness of different varnishes for treating dental white spots. Studies have shown that fluoride varnishes can help treat white spot lesions, early signs of cavities. Participants in this trial may receive a 5% sodium fluoride varnish, which research indicates can help restore minerals to these spots, partially reversing the damage. Another group will receive resin-modified glass ionomer (RMGI) varnishes, which previous findings suggest are particularly effective at preventing further mineral loss from tooth enamel and outperform some other fluoride options. Both types of varnishes show promise in managing and improving white spot lesions after orthodontic treatment. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5995463/

Randomized controlled trial on fluoride varnish application ... The purpose of this study was to determine the efficacy of fluoride varnish (5% sodium fluoride, Duraphat®, Colgate) in reverting white spot lesions (WSLs) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11340118/

Remineralizing effect of NSF on artificial enamel caries A thorough evaluation found that 5% Sodium Fluoride (NaF) varnish was more efficient in remineralizing early enamel caries. Despite the ...

3. karger.com karger.com/cre/article/58/6/589/910630/Effectiveness-of-Fluoride-Varnishes-for-White-Spot

Effectiveness of Fluoride Varnishes for White Spot Lesion ... In conclusion, TiF4 varnish proved most effective in preventing and remineralizing WSLs in a 12-month follow-up during orthodontic treatment.

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-023-02799-1

Comparative evaluation of prevention of demineralization of ... In primary teeth, WSLs treated with MI varnish displayed better resistance to demineralization compared to WSLs treated with Clinpro white varnish and SDF.

5. karger.com karger.com/cre/article/doi/10.1159/000545160/923634/Fluoride-Varnish-Efficacy-on-the-Remineralization

Fluoride Varnish Efficacy on the Remineralization of Early ... In vitro studies show that fluoride varnishes (FVs) differ significantly in their ability to remineralize and fluoridate enamel caries lesions.

6. darbydental.com darbydental.com/categories/Preventive-Products/Varnish/Fluor-Protector-S/5240070

Fluor Protector S Fluor Protector S is a fluoride containing protective varnish. It is used as a treatment to dentinal hypersensitivity and exposed cervicals.

7. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l00xM82G58_B4v70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1: Identification SECTION 2 This product is a flammable liquid, causes serious eye damage, may be fatal if swallowed, and is suspected of damaging fertility. It also causes organ damage ...

8. pattersondental.com pattersondental.com/en-CA/Sds?publicItemNumber=071896539

071896539 - The safety data sheets (SDS) in this packet ... FluoroDose® is a great-tasting, sodium fluoride varnish containing 50mg of sodium fluoride (equivalent to 22.6mg fluoride ion) per 1 ml. The convenient ...

9. employees.delta.edu employees.delta.edu/facilities/_safety-data-sheets/varnish-sodium-fluoride-5-benco-dental.pdf

safety data sheet varnish sodium fluoride 5% The product is highly flammable, harmful if swallowed, causes serious eye irritation, and is a skin sensitizer. Keep away from heat and children.

10. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8lZ09M82G58_9mv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1: Identification SECTION 2 This product is a flammable liquid, causes serious eye irritation, suspected of damaging fertility, and may be fatal if swallowed and enters ...