RECRUITING

Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-12
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05964387

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.

Ages Eligible for Study:6 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * American Society of Anesthesiologists (ASA) Physical Status Classification I or II (healthy children or those with mild systemic disease)
  3. * English speaking
  4. * Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated
  1. * Teeth with irreversible pulpitis and pulp necrosis
  2. * Patients requiring advanced behavior management such as moderate sedation, general anesthesia, and/or active or passive restraint
  3. * Inability of the child to cooperate due to special needs or other conditions
  4. * Allergy to SDF, local anesthetic or other material component
  5. * Subjects with ulcerative gingivitis or stomatitis
  6. * Subjects with known sensitivity to silver or other heavy-metal ions
  7. * Subjects showing abnormal skin sensitization in daily circumstances

Contacts and Locations

Study Contact

James Boynton, DDS
CONTACT
734-763-2331
jboynton@umich.edu

Principal Investigator

James Boynton, DDS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • James Boynton, DDS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • Silver diamine fluoride

Additional Relevant MeSH Terms

  • Molar Incisor Hypomineralization
  • Anesthesia, Local