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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

Study Summary

This trial will study if pre-treatment with 38% SDF can reduce pain in permanent molars affected by MIH during dental procedures.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sixou and Barbosa-Rogier scale for local anesthesia efficacy

Secondary outcome measures

Schiff Cold Air Sensitivity Scale

Other outcome measures

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

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,088 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accommodating elderly participants?

"This trial is seeking young patients aged 6 to 11 years old."

Answered by AI

Is recruitment for this trial still taking place?

"According to the most recent update on clinicaltrials.gov, this trial is seeking volunteers and it was initially posted on June 12th 2023 with its last edit occurring July 18th 2023."

Answered by AI

What criteria must be satisfied in order to enroll in this medical study?

"To be included in this medical experiment, children aged between 6 and 11 that have been diagnosed with molar incisor hypomineralization are eligible. In total, 50 participants will take part."

Answered by AI

What is the aggregate amount of participants in this clinical study?

"Affirmative. Data stored on clinicaltrials.gov attests that this medical experiment, which was first announced on June 12th 2023, is currently recruiting individuals to join the trial. Only 50 patients are needed from 1 research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

James R. Boynton 2023. "Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05964387.