Recruiting

SDF

Sponsor:

University of Michigan

Code:

NCT05964387

Conditions

Molar Incisor Hypomineralization

Anesthesia, Local

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Interventions

SDF

Placebo

Study Details

Brief 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

Study ID

NCT05964387

Start date

Jun 12, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SDF

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

Placebo

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

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 and Locations

Central contacts

James Boynton, DDS

734-763-2331jboynton@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

James R Boynton, DDS

734 764-1523jboynton@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Silver diamine fluoride

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-02-12.