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
Qualifiers
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
Treatments tested in this trial
- SDF
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov