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Search / Trial NCT05964387

Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Launched by UNIVERSITY OF MICHIGAN · Jul 18, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Silver Diamine Fluoride

ClinConnect Summary

This clinical trial is studying whether a special treatment called Silver Diamine Fluoride (SDF) can help make local anesthesia (the numbing medicine used during dental work) more effective for children with certain dental issues. Specifically, it focuses on children who have a condition called Molar Incisor Hypomineralization (MIH), which can make their teeth more sensitive and difficult to treat. Researchers want to see if applying SDF before dental procedures can reduce pain and improve the numbing effect of the anesthesia.

To participate, children need to be between the ages of 2 and 17 and have at least one damaged permanent molar tooth that requires treatment. They should be generally healthy, able to understand instructions, and not have severe dental problems or allergies related to the treatment. If selected, participants will receive the SDF treatment and local anesthesia, and their experience will be monitored to see how well the procedure works. This trial aims to create better dental care practices for children with MIH, ultimately making visits to the dentist less painful and stressful.

Gender

ALL

Eligibility criteria

  • Inclusion 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
  • Exclusion Criteria:
  • 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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

James Boynton, DDS

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported