Actively Recruiting
Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
Led by University of Michigan · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Molar incisor hypomineralization (MIH) is a tooth enamel defect that affects permanent molars and incisors, causing sensitivity and rapid dental caries progression. This research aims to evaluate whether applying 38% silver diamine fluoride (SDF) before dental treatment improves the effectiveness of local anesthesia in children with MIH, addressing challenges in managing pain during treatment. The trial is randomized and controlled to help develop better treatment protocols for affected molars. Participants will receive either 38% SDF or an inert liquid as a placebo applied to the affected molar two weeks before restorative dental care. This pre-treatment aims to reduce tooth sensitivity by blocking dentinal tubules and promoting remineralization, potentially improving anesthesia efficacy and reducing pain during procedures. During the study, children will undergo dental treatment on the treated molars after the two-week period. Researchers will assess anesthesia effectiveness using the Sixou and Barbosa-Rogier scale and measure tooth sensitivity with the Schiff Cold Air Sensitivity Scale. The study includes monitoring for adverse reactions and aims to provide data to improve pain management in teeth affected by MIH.
CONDITIONS
Brief 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 or cavitated tooth defect needing 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 whom 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, or active/passive restraint
- Inability to cooperate due to special needs or other conditions
- Allergy to silver diamine fluoride, local anesthetic, or other materials
- 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive an application of either 38% silver diamine fluoride (SDF) or an inert liquid to the hypomineralized permanent molar two weeks prior to restorative dental care to improve local anesthesia efficacy.
1 visit (in-person)
Duration - 1 day
Participants undergo restorative dental care with local anesthesia on the treated molar to evaluate anesthesia effectiveness and procedural pain.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
James Boynton, DDS
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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