Using silver diamine fluoride to improve anesthesia in children with hypomineralized molars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effectiveness of 38% silver diamine fluoride (SDF) in enhancing local anesthesia during dental procedures on permanent molars affected by molar-incisor hypomineralization (MIH). The randomized, controlled design aims to determine if pre-operative application of SDF can reduce procedural pain and improve anesthesia efficacy in these patients. MIH presents unique challenges due to increased tooth sensitivity and reduced pain control, making effective treatment crucial. The study seeks to contribute to the development of a standardized treatment protocol for managing MIH-affected teeth.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: James Boynton, DDS — University of Michigan
• Study coordinator: James Boynton, DDS
• Email: jboynton@umich.edu
• Phone: 734-763-2331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.