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Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial

Who can join

Ages 6 to 11 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• SDF (device)
• Placebo (device)

Sponsor: University of Michigan · Participants: 50 · Started: Jun 12, 2023

Contact the study team

• James Boynton, DDS · Phone: 734-763-2331

Official record on ClinicalTrials.gov — NCT05964387

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.