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Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

NCT05964387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-12

No results posted yet for this study

Summary

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

Interventions

DEVICE

SDF

38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.

DEVICE

Placebo

An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.

Sponsors & Collaborators

Principal Investigators

  • James Boynton, DDS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964387 on ClinicalTrials.gov