Silver Diamine Fluoride for Molar Hypomineralization

Overseen by James Boynton, DDS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Disqualifiers: Irreversible pulpitis, Pulp necrosis, Allergy, others

Trial Summary

What is the purpose of this trial?

This trial is testing if applying a special liquid called silver diamine fluoride (SDF) before dental procedures can help numb teeth better and reduce pain for patients with sensitive teeth due to a condition called molar-incisor hypomineralization (MIH). MIH makes teeth more sensitive and harder to treat with regular anesthesia. SDF works by blocking tiny holes in the teeth and making them stronger, which could help make dental treatments less painful. SDF has been used for many years to control early childhood cavities, stop root cavities, prevent various types of cavities, reduce tooth sensitivity, strengthen weak teeth, prevent dental erosion, detect decayed tissue during treatment, and manage infected root canals.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Silver Diamine Fluoride for Molar Hypomineralization?

Silver Diamine Fluoride (SDF) has been shown to be effective in stopping tooth decay and helping to strengthen tooth enamel, especially in children. While the studies focus on its use for cavities, this suggests it might also help with molar hypomineralization by reinforcing weakened enamel. ^{1 2 3 4 5}

Is silver diamine fluoride (SDF) safe for humans?

Research on silver diamine fluoride (SDF) has looked at its use in dental care, particularly for managing cavities in children. Studies have investigated its short-term and long-term effects, and while they focus on its effectiveness, they also monitor for any adverse effects, suggesting it is generally considered safe for use in humans. ^{2 5 6 7 8}

How is silver diamine fluoride different from other treatments for molar hypomineralization?

Silver diamine fluoride (SDF) is unique because it combines silver, which has antibacterial properties, with fluoride, which helps strengthen teeth, to stop tooth decay and promote remineralization. Unlike other treatments, SDF is applied topically and is known for its ability to arrest dental caries effectively, making it a novel option for managing molar hypomineralization. ^{1 2 3 5 7}

Research Team

James Boynton, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Placebo (Other)
• SDF (Other)

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.

Participant Groups

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+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. [2020]

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

Stability of Silver and Fluoride Contents in Silver Diamine Fluoride Solutions. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Effect of application time and concentration of silver diamine fluoride on the enamel remineralization. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. [2020]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics of 38% silver diamine fluoride in healthy children with dental caries: a quasi-experimental study. [2023]

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

Silver and fluoride content and short-term stability of 38% silver diamine fluoride. [2023]