Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Molar Incisor Hypomineralization, Anesthesia, Local

In brief

The purpose of this randomized, controlled clinical study is to evaluate if application of 38% SDF increases the efficacy of local anesthesia during operative dentistry on permanent molars affected by molar-incisor hypoplasia (MIH). 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 addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.

Key facts

Study ID

NCT05964387

Run by

University of Michigan

People needed

50

Starts

2023-06-12

Expected to finish

2027-12-31

Last updated by the study team

2026-02-12

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• At least one hypomineralized first permanent molar with a primary cavitated caries lesion(s) or a cavitated tooth defect requiring restorative dental care with local anesthesia
• American Society of Anesthesiologists (ASA) Physical Status Classification I or II (healthy children or those with mild systemic disease)
• English speaking
• Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated

You may not qualify if…

• Teeth with irreversible pulpitis and pulp necrosis
• Patients requiring advanced behavior management such as moderate sedation, general anesthesia, and/or active or passive restraint
• Inability of the child to cooperate due to special needs or other conditions
• Allergy to SDF, local anesthetic or other material component
• Subjects with ulcerative gingivitis or stomatitis
• Subjects with known sensitivity to silver or other heavy-metal ions
• Subjects showing abnormal skin sensitization in daily circumstances

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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