Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05964387
Status
Recruiting
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Conditions

  • Anesthesia, Local
  • Molar Incisor Hypomineralization

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • SDF — DEVICE
    38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
  • Placebo — DEVICE
    An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SDF
    38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
  • Placebo Comparator: Placebo
    Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Primary Outcome Measure

Sixou and Barbosa-Rogier scale for local anesthesia efficacy [ Time Frame: At least two weeks following application of SDF or placebo on the enrolled tooth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
James R Boynton, DDS
[email protected]
734 764-1523

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

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