Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

NCT05964387 | Recruiting FDA Device

• 1 other identifier: HUM00228059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Silver diamine fluoride

Outcome Measures

Primary Outcomes (1)

• Sixou and Barbosa-Rogier scale for local anesthesia efficacy

  Four point scale evaluating efficacy of local anesthesia

  At least two weeks following application of SDF or placebo on the enrolled tooth

Secondary Outcomes (1)

• Schiff Cold Air Sensitivity Scale

  At least two weeks following application of SDF or placebo on the enrolled tooth

Other Outcomes (1)

• Face, Legs, Activity, Cry, Consolability (FLACC) Scale

  At least two weeks following application of SDF or placebo on the enrolled tooth

Study Arms (2)

SDF

EXPERIMENTAL

38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Device: SDF

Placebo

PLACEBO COMPARATOR

Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Device: Placebo

Interventions

SDF DEVICE

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

SDF

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• James Boynton, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Boynton, DDS

CONTACT

734-763-2331; jboynton@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject, care provider/outcomes assessor, and investigator will be blinded to which arm the tooth is randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)