Silver Diamine Fluoride for Molar Hypomineralization
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
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.
12345Is 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.
25678How 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.
12357Eligibility 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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SDFExperimental Treatment1 Intervention
38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
Group II: PlaceboPlacebo Group1 Intervention
Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who is running the clinical trial?
University of MichiganLead Sponsor
References
Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. [2020]Silver diamine fluoride (SDF) is used topically to prevent or arrest caries. The authors' aim was to characterize the kinetics of silver and fluoride after topical application of SDF.
Stability of Silver and Fluoride Contents in Silver Diamine Fluoride Solutions. [2023]This study aims to determine the stability, alkalinity, and fluoride and silver ion concentrations of 5 commercially available 38% silver diamine fluoride (SDF) solutions-namely Advantage Arrest, e-SDF, Riva Star, Saforide, and Topamine-in 180 days.
Effect of application time and concentration of silver diamine fluoride on the enamel remineralization. [2022]Silver diamine fluoride has attracted attention because of its clinical success in arresting dental caries. Thus, the aim of this study was to evaluate the effect of different application times and concentrations of silver diamine fluoride (SDF) on deciduous tooth enamel remineralization.
Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. [2020]Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The objective of this randomised clinical trial is to determine whether 38% SDF solution is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth.
Silver Diammine Fluoride: Rejuvination of a 172-Year-Old (or Older?) Dental Caries Attenuation. [2020]In 2015, Elevate Oral Care (http://www.elevateoralcare.com) introduced a 38% silver diammine fluoride (SDF) solution to the dentistry marketplace in North America. The company named the product "Advantage Arrest™ Silver Diamine Fluoride 38%" (Figure 1). The chemistry and nomenclature for SDF (AgFH6N2) is described as such: "Silver diammine fluoride is a metal ammine complex of silver fluoride. The ammonia ligands are thus "ammine", but the term "amine" is sometimes used incorrectly for this chemical. In addition to that spelling difference, it is sometimes also called "ammoniacal silver fluoride", which is also sometimes improperly spelled as "ammonical silver fluoride."1.
Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. [2021]Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children's and parents' acceptance of these fluoride therapies and (iii) to investigate the short-term (1 day) and long-term (1 year) adverse effects of these fluoride therapies.
The pharmacokinetics of 38% silver diamine fluoride in healthy children with dental caries: a quasi-experimental study. [2023]Silver diamine fluoride (SDF) is a medication used for the arrestment of dental caries. This study aims to determine the pharmacokinetics (PK) of silver and fluoride following SDF application in healthy children with dental caries.
Silver and fluoride content and short-term stability of 38% silver diamine fluoride. [2023]As silver diamine fluoride (SDF) gains popularity for caries arrest, the authors aimed to investigate the content of fluoride and silver in 38% SDF produced for the US market and its short-term stability.