What side effects are associated with this type of intervention?

Common side effects of local anesthesia treatments include pain at the injection site, swelling, and bruising. Some patients may experience dizziness, headache, or a temporary increase in heart rate. In rare cases, allergic reactions can occur, leading to symptoms such as itching, rash, or difficulty breathing. Treatments similar to 38% Silver Diamine Fluoride (SDF), which aim to enhance local anesthesia efficacy and reduce procedural pain, generally share these side effects but are typically well-tolerated.

What prior FDA approvals exist?

Local anesthetics such as lidocaine and prilocaine have been widely approved by the FDA for various medical and dental procedures to manage pain. These agents are often used in formulations like gels, creams, and injections to provide effective local anesthesia. For instance, a thermosetting gel containing prilocaine and lidocaine has been studied for its efficacy in producing analgesia in periodontal therapy. While Silver Diamine Fluoride (SDF) is primarily known for its use in dental caries management, its potential to enhance local anesthesia efficacy and reduce procedural pain in hypomineralized molars is being explored. This aligns with the broader category of local anesthetics aimed at improving patient comfort during dental treatments.

What other types of research exist?

Promising alternatives to 38% SDF for enhancing local anesthesia efficacy and reducing procedural pain include the use of magnesium sulfate (MgSO4) as an adjunct to lignocaine. A randomized double-blind controlled clinical trial demonstrated that adding MgSO4 to 2% lignocaine improved the onset, anesthetic efficacy, duration, and post-operative analgesia in patients with symptomatic irreversible pulpitis and apical periodontitis. This suggests that MgSO4 could be a viable alternative to SDF in enhancing local anesthesia.

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Other

Silver Diamine Fluoride for Molar Hypomineralization

N/A

Recruiting

Led By James Boynton, DDS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at least two weeks following application of sdf or placebo on the enrolled tooth

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of SDF include temporary staining of the skin and mucous membranes near application site, metallic taste in mouth, and very rarely an allergic reaction if there's sensitivity to silver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least two weeks following application of sdf or placebo on the enrolled tooth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least two weeks following application of sdf or placebo on the enrolled tooth

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least two weeks following application of sdf or placebo on the enrolled tooth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sixou and Barbosa-Rogier scale for local anesthesia efficacy

Secondary study objectives

Schiff Cold Air Sensitivity Scale

Other study objectives

Face, Legs, Activity, Cry, Consolability (FLACC) Scale

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SDF

2018

Completed Phase 3

~1570

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthesia works by blocking nerve conduction, specifically by inhibiting sodium channels on the nerve cell membrane, which prevents the initiation and transmission of nerve impulses. This results in a temporary loss of sensation in the targeted area. Treatments like lidocaine and bupivacaine are commonly used local anesthetics. The application of 38% Silver Diamine Fluoride (SDF) has been studied for its potential to enhance the efficacy of local anesthesia and reduce procedural pain, particularly in hypomineralized molars. This is significant for patients as it can lead to more effective pain management and a more comfortable experience during dental procedures.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,833 Previous Clinical Trials

6,423,078 Total Patients Enrolled

James Boynton, DDSPrincipal InvestigatorUniversity of Michigan

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05964387 — N/A

Local Anesthesia Research Study Groups: SDF, Placebo

Local Anesthesia Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05964387 — N/A

Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964387 — N/A

~25 spots leftby Dec 2025

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