Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Description

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.

Conditions

Molar Incisor Hypomineralization, Anesthesia, Local

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Study Overview

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Study Details

Study overview

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.

Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial

Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Condition
Molar Incisor Hypomineralization
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

6 Years to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Michigan,

James Boynton, DDS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2026-07-01