Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SDF
Device38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
Placebo
DeviceAn inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SDFExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sixou and Barbosa-Rogier scale for local anesthesia efficacy
Four point scale evaluating efficacy of local anesthesia
Time frame
At least two weeks following application of SDF or placebo on the enrolled toothSecondary outcomes
1
Schiff Cold Air Sensitivity Scale
Four point scale evaluating tooth sensitivity to cold
Time frame
At least two weeks following application of SDF or placebo on the enrolled toothOther outcomes
1
Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Three point scale evaluating five components of behavior and expression of discomfort in children
Time frame
At least two weeks following application of SDF or placebo on the enrolled toothSponsors and contacts
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Source ClinicalTrials.gov