Actively Recruiting
Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
Led by University of Michigan · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
James Boynton, DDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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