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NCT Number: NCT05964387

Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

James R Boynton, DDS

CONTACT

[email protected]

734 764-1523

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    Four point scale evaluating efficacy of local anesthesia

Secondary outcomes

  1. Schiff Cold Air Sensitivity Scale

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

    Four point scale evaluating tooth sensitivity to cold

Other outcomes

  1. Face, Legs, Activity, Cry, Consolability (FLACC) Scale

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

    Three point scale evaluating five components of behavior and expression of discomfort in children

Study contacts

Contact information is provided by the study sponsor or research team.

James Boynton, DDS

CONTACT

[email protected]

734-763-2331

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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