Silver Diamine Fluoride for Molar Hypomineralization

Overseen By James Boynton, DDS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Irreversible pulpitis, Pulp necrosis, Allergy, others

Compensation: Varies

Number of Visits: 3

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether silver diamine fluoride (SDF) can reduce pain during dental work for individuals with molar-incisor hypoplasia (MIH), a condition that weakens teeth. Researchers aim to determine if applying 38% SDF before dental procedures enhances the effectiveness of local anesthesia and reduces pain during treatment. Participants will receive either SDF or a placebo (a harmless liquid) on their affected molars two weeks before dental care. Those with a permanent molar requiring cavity treatment and who can manage basic behavior guidance may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of how SDF can improve dental care for those with MIH.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that silver diamine fluoride (SDF) is generally safe for dental use. Dentists often use it to stop tooth decay, and it has FDA approval for treating sensitive teeth. Studies have found that SDF can make teeth harder and denser, which is beneficial. However, it might cause minor side effects such as irritation to the skin, eyes, or respiratory system, which are usually mild. Overall, SDF is considered a well-tolerated option in dental care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Silver Diamine Fluoride (SDF) because it offers a unique approach to treating molar hypomineralization. Unlike traditional treatments that often involve invasive procedures like fillings or crowns, SDF is simply painted onto the tooth. It works by using a high concentration of fluoride, which helps strengthen the tooth enamel and prevent further decay. This non-invasive method not only simplifies the treatment process but also reduces discomfort for patients, making it an appealing option for managing this dental condition.

What evidence suggests that this trial's treatments could be effective for molar hypomineralization?

In this trial, participants will receive either silver diamine fluoride (SDF) at 38% or a placebo treatment. Research has shown that SDF is effective for dental treatments. Studies have found that SDF reduces the likelihood of tooth decay by decreasing the permeability of dental tissues. This treatment can halt the progression of cavities. In past studies, SDF successfully prevented further tooth decay and received positive feedback from both patients and parents, particularly for treating molars with conditions like molar-incisor hypoplasia (MIH). This makes it a promising option for managing dental pain and enhancing the effectiveness of local anesthesia during dental procedures. ^{2 5 6 7 8}

Who Is on the Research Team?

James Boynton, DDS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for children with a condition called molar-incisor hypomineralization who need dental work done on their molars. They should be generally healthy or have mild systemic disease, able to understand English, and manageable with basic non-drug guidance or laughing gas during dental procedures.

Inclusion Criteria

I need guidance or nitrous oxide for my treatment.

I have a permanent molar with a cavity or defect that needs filling with anesthesia.

English speaking

Exclusion Criteria

Allergy to SDF, local anesthetic or other material component

Inability of the child to cooperate due to special needs or other conditions

Subjects showing abnormal skin sensitization in daily circumstances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Application of 38% SDF or placebo to hypomineralized permanent molar

2 weeks

1 visit (in-person)

Treatment

Restorative care of the tooth following pre-treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for local anesthesia efficacy and tooth sensitivity

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SDF

Trial Overview

The study tests if applying a solution called Silver Diamine Fluoride (SDF) before giving local anesthesia helps reduce pain better than a placebo when treating sensitive molars. It's randomized, meaning patients are put into the SDF or placebo group by chance.

How Is the Trial Designed?

Group I: SDF Experimental Treatment 1 Intervention

38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Group II: Placebo Placebo Group 1 Intervention

Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The study found that while the alkalinity of five different 38% silver diamine fluoride (SDF) solutions remained stable over 180 days, their fluoride and silver ion concentrations significantly decreased after 60 days, indicating a loss of efficacy over time.

It is recommended that these SDF solutions be used within 60 days of opening to ensure optimal therapeutic benefits, as substantial changes in fluoride and silver concentrations were observed beyond this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of Silver and Fluoride Contents in Silver Diamine Fluoride Solutions. Yan, IG., Zheng, FM., Yin, IX., et al.[2023]

Elevate Oral Care introduced a 38% silver diammine fluoride (SDF) solution called Advantage Arrest™ in North America in 2015, which is used in dentistry for its potential to treat dental caries.

Silver diammine fluoride is a metal ammine complex that combines silver and fluoride, and it is recognized for its ability to halt the progression of cavities, making it a valuable tool in dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver Diammine Fluoride: Rejuvination of a 172-Year-Old (or Older?) Dental Caries Attenuation. Croll, TP., Berg, JH.[2020]

A study involving 16 adults showed that topical application of 38% silver diamine fluoride (SDF) is safe and well tolerated, with no reported adverse events.

The pharmacokinetics revealed that silver peaks in the serum at 0.67 nanograms per milliliter within 3 hours, and no silver was found in urine, indicating minimal systemic absorption after application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. Lin, YS., Rothen, ML., Milgrom, P.[2020]

In a study of 15 healthy children aged 4 to 10 years, silver diamine fluoride (SDF) treatment effectively halted the progression of dental caries without any reported adverse effects, indicating its safety for use in pediatric dentistry.

While urinary fluoride levels increased after SDF application, they were not clinically significant, and both urinary and hair silver levels remained negligible, suggesting that SDF is safe and well-tolerated in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics of 38% silver diamine fluoride in healthy children with dental caries: a quasi-experimental study. Lim, SP., Zainal Aalam, N., Chik, Z., et al.[2023]

Silver diamine fluoride (SDF) is effective in promoting enamel remineralization in deciduous teeth, with a 1-minute application time showing positive results regardless of whether a 30% or 38% concentration is used.

The 30% SDF solution applied for 3 minutes resulted in significantly fewer pores in the enamel compared to other groups, indicating better structural integrity after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of application time and concentration of silver diamine fluoride on the enamel remineralization. Punhagui, MF., Jussiani, EI., Andrello, AC., et al.[2022]

Over a 28-day period, the pH of silver diamine fluoride (SDF) remained stable, but the fluoride content increased significantly while the silver content decreased, which could affect its efficacy in caries arrest.

The drops dispensed from the SDF bottle were found to be larger than expected, delivering higher amounts of fluoride and silver than anticipated, prompting clinicians to use caution, especially with young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver and fluoride content and short-term stability of 38% silver diamine fluoride. Crystal, YO., Rabieh, S., Janal, MN., et al.[2023]

This study will compare the effectiveness of silver diamine fluoride (SDF) and sodium fluoride (NaF) in stopping and preventing cavities in 688 healthy 3-year-old children over a year, providing valuable insights into their caries management.

The trial will also assess the acceptance of these treatments by children and parents, as well as any short-term and long-term side effects, which is crucial for understanding the overall impact of these fluoride therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. Gao, SS., Zheng, FM., Chen, KJ., et al.[2021]

This clinical trial aims to compare the effectiveness of 38% silver diamine fluoride (SDF) solution against 5% sodium fluoride (NaF) varnish in preventing new cavities in primary anterior teeth among approximately 730 healthy 3-year-old children over a period of 30 months.

If proven effective, the study could lead to a shift in dental care standards for early childhood caries (ECC) prevention, potentially increasing the use of SDF globally to combat ECC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. Gao, SS., Chen, KJ., Duangthip, D., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11109571/

Preventive efficacy of 38% silver diamine fluoride and CPP ...

This randomized controlled trial aimed to compare the efficacy of silver diamine fluoride (SDF) and casein phosphopeptide-amorphous calcium phosphate fluoride ...

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reporter.nih.gov

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Phase III RCT of the Effectiveness of Silver Diamine ...

Summary The proposed Cooperative Agreement is for support for a Phase III randomized clinical trial (RCT) to assess the effectiveness of 38% silver diamine ...

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This study introduces a computational method to measure dental tissue permeability, and demonstrates that SDF significantly reduces permeability in carious ...

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Silver Diamine Fluoride

Evidence shows that SDF at 38% can be an effective, noninvasive treatment option to arrest dentinal caries. ... Safety Data Sheet--Advantage ...

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nature.com

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Parental satisfaction and acceptance of silver diamine ...

The study aimed to investigate parental satisfaction and acceptance of silver diamine fluoride (SDF) treatment for permanent molars affected by molar incisor ...

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elevateoralcare.com

elevateoralcare.com/site/images/AASDS082415.pdf

Safety Data Sheet

This product is for dental use only. It may cause respiratory, eye, and skin irritation. It may also cause respiratory issues, and may be ...

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oralscience.com

oralscience.com/en/products/advantage-arrest/

Advantage Arrest

Advantage Arrest, made of Silver Diamine Fluoride, arrests cavity progress in permanent and primary teeth, increasing mineral density and hardness.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05964387

Effect of Silver Diamine Fluoride on Local Anesthesia in ...

The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby ...