Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

NCT ID: NCT05964387

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2026-07-01

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.

Detailed Description

Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown etiology that affects one or more permanent molars and may also affect the permanent incisors. Clinically, the presentation of MIH depends on severity: lesions can range from mild, with white to yellow-brown discolored opacities, to severe, with extensive post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased porosity with reduced mineral content, which promotes bacteria penetration, resulting in development and rapid progression of dental caries and subclinical chronic pulp inflammation.

Treatment of teeth affected by MIH pose a clinical challenge due to several reasons. Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in hypersensitivity to hot and cold temperatures, air, and water. This increased tooth sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA) receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This weakens the action of local anesthetics making it difficult to achieve adequate pain control during dental treatment.

Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions, has been shown to be effective in tooth desensitization by blocking dentinal tubules and promoting remineralization of demineralized tooth structure. SDF can be useful in managing symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver iodide, both of which are able to occlude dentinal tubules and reduce their patency.

The purpose of this randomized, controlled clinical study is to evaluate the efficacy of local anesthesia on MIH-affected molars treated with 38% SDF. 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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SDF

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

Group Type: EXPERIMENTAL

SDF

Intervention Type: DEVICE

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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

Interventions

SDF

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

Intervention Type: DEVICE

Placebo

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

James R. Boynton

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Boynton, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James Boynton, DDS

Role: CONTACT

jboynton@umich.edu

734-763-2331

Facility Contacts

James R Boynton, DDS

Role: primary

jboynton@umich.edu

734 764-1523

Other Identifiers

HUM00228059

Identifier Type: -

Identifier Source: org_study_id