University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
NCT Number: NCT05964387
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.
Interested in participating?
Request Info6 year–11 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
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 pulp inflammation.
Treatment of teeth affected by MIH pose a clinical challenge due to several reasons. Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in hypersensitivity to hot and cold temperatures, air, and water. This increased tooth sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA) receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This weakens the action of local anesthetics making it difficult to achieve adequate pain control during dental treatment.
Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions, has been shown to be effective in tooth desensitization by blocking dentinal tubules and promoting remineralization of demineralized tooth structure. SDF can be useful in managing symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver iodide, both of which are able to occlude dentinal tubules and reduce their patency.
The purpose of this randomized, controlled clinical study is to evaluate the efficacy of local anesthesia on MIH-affected molars treated with 38% SDF. 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
Time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
Four point scale evaluating efficacy of local anesthesia
Time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
Four point scale evaluating tooth sensitivity to cold
Time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
Three point scale evaluating five components of behavior and expression of discomfort in children
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
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