Status:
RECRUITING
Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
Lead Sponsor:
University of Michigan
Conditions:
Molar Incisor Hypomineralization
Anesthesia, Local
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief Summary
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...
Detailed Description
Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown etiology that affects one or more permanent molars and may also affect the permanent incisors. Clinically, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05964387
Start Date
June 12 2023
End Date
July 1 2026
Last Update
August 21 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109