Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
University of Michigan
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 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.
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, the presentation of MIH depends on severity: lesions can range from mild, with white to yellow-brown discolored opacities, to severe, with extensive post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased porosity with reduced mineral content, which promotes bacteria penetration, resulting in development and rapid progression of dental caries and subclinical chronic…
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- Yes
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 mode…
Interventions
- DeviceSDF
38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
- DevicePlacebo
An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
Location
- University of MichiganAnn Arbor, Michigan