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Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

University of Michigan · NCT05964387

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–11 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
June 12, 2023
Record last updated
February 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SDF; Placebo

Conditions: Molar Incisor Hypomineralization; Anesthesia, Local

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: James R Boynton, DDS · 734 764-1523 · jboynton@umich.edu

Study contacts (from the official record)

  • James Boynton, DDS · 734-763-2331 · jboynton@umich.edu
All healthy volunteers studies in Michigan →
Effect of Silver Diamine Fluoride on Local Anesthesia in… (NCT05964387) | Bored Studies