Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Molar Incisor Hypomineralization, Anesthesia, Local

Intervention / Treatment
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* Device: SDF
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDF<br>38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. | Device: SDF<br>* 38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.<br>* Other names: 2% lidocaine with 1:100,000 epinephrine;|
| Placebo Comparator: Placebo<br>Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. | Device: Placebo<br>* An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schiff Cold Air Sensitivity Scale | Four point scale evaluating tooth sensitivity to cold | At least two weeks following application of SDF or placebo on the enrolled tooth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver diamine fluoride