Using silver diamine fluoride to improve anesthesia in children with hypomineralized molars
Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
This study is testing if applying silver diamine fluoride before dental work can help make local anesthesia work better and reduce pain for children with sensitive molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05964387 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children with at least one hypomineralized first permanent molar requiring restorative care and who are ASA Physical Status Classification I or II.
Not a fit: Patients with irreversible pulpitis, those requiring advanced behavior management, or those with allergies to SDF or local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve dental treatment outcomes for children with hypomineralized molars.
How similar studies have performed: While the use of silver diamine fluoride has shown promise in other contexts, this specific application in enhancing local anesthesia for MIH is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.