xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964387</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00228059</org_study_id>
      <nct_id>NCT05964387</nct_id>
    </id_info>
    <brief_title>Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars</brief_title>
    <official_title>Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this randomized, controlled clinical study is to evaluate if application of&#xD;
        38% SDF increases the efficacy of local anesthesia during operative dentistry on permanent&#xD;
        molars affected by molar-incisor hypoplasia (MIH). The goal is to determine if pre-operative&#xD;
        application of SDF results in improved local anesthesia and decrease in procedural pain in&#xD;
        MIH affected teeth, thereby addressing an important challenge in routine clinical practice&#xD;
        and contributing to the development of a treatment protocol for MIH affected molars.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown&#xD;
        etiology that affects one or more permanent molars and may also affect the permanent&#xD;
        incisors. Clinically, the presentation of MIH depends on severity: lesions can range from&#xD;
        mild, with white to yellow-brown discolored opacities, to severe, with extensive&#xD;
        post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased&#xD;
        porosity with reduced mineral content, which promotes bacteria penetration, resulting in&#xD;
        development and rapid progression of dental caries and subclinical chronic pulp inflammation.&#xD;
  &#xD;
        Treatment of teeth affected by MIH pose a clinical challenge due to several reasons.&#xD;
        Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in&#xD;
        hypersensitivity to hot and cold temperatures, air, and water. This increased tooth&#xD;
        sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic&#xD;
        subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA)&#xD;
        receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This&#xD;
        weakens the action of local anesthetics making it difficult to achieve adequate pain control&#xD;
        during dental treatment.&#xD;
  &#xD;
        Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions,&#xD;
        has been shown to be effective in tooth desensitization by blocking dentinal tubules and&#xD;
        promoting remineralization of demineralized tooth structure. SDF can be useful in managing&#xD;
        symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver&#xD;
        iodide, both of which are able to occlude dentinal tubules and reduce their patency.&#xD;
  &#xD;
        The purpose of this randomized, controlled clinical study is to evaluate the efficacy of&#xD;
        local anesthesia on MIH-affected molars treated with 38% SDF. The goal is to determine if&#xD;
        pre-operative application of SDF results in improved local anesthesia and decrease in&#xD;
        procedural pain in MIH affected teeth, thereby addressing an important challenge in routine&#xD;
        clinical practice and contributing to the development of a treatment protocol for MIH&#xD;
        affected molars.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The subject, care provider/outcomes assessor, and investigator will be blinded to which arm the tooth is randomized.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sixou and Barbosa-Rogier scale for local anesthesia efficacy</measure>
      <time_frame>At least two weeks following application of SDF or placebo on the enrolled tooth</time_frame>
      <description>Four point scale evaluating efficacy of local anesthesia</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Schiff Cold Air Sensitivity Scale</measure>
      <time_frame>At least two weeks following application of SDF or placebo on the enrolled tooth</time_frame>
      <description>Four point scale evaluating tooth sensitivity to cold</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Face, Legs, Activity, Cry, Consolability (FLACC) Scale</measure>
      <time_frame>At least two weeks following application of SDF or placebo on the enrolled tooth</time_frame>
      <description>Three point scale evaluating five components of behavior and expression of discomfort in children</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Molar Incisor Hypomineralization</condition>
    <condition>Anesthesia, Local</condition>
    <arm_group>
      <arm_group_label>SDF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SDF</intervention_name>
      <description>38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.</description>
      <arm_group_label>SDF</arm_group_label>
      <other_name>2% lidocaine with 1:100,000 epinephrine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least one hypomineralized first permanent molar with a primary cavitated caries&#xD;
               lesion(s) or a cavitated tooth defect requiring restorative dental care with local&#xD;
               anesthesia&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) Physical Status Classification I or II&#xD;
               (healthy children or those with mild systemic disease)&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Subjects for which basic behavior guidance (non-pharmacological or nitrous&#xD;
               oxide/oxygen) is indicated&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth with irreversible pulpitis and pulp necrosis&#xD;
  &#xD;
            -  Patients requiring advanced behavior management such as moderate sedation, general&#xD;
               anesthesia, and/or active or passive restraint&#xD;
  &#xD;
            -  Inability of the child to cooperate due to special needs or other conditions&#xD;
  &#xD;
            -  Allergy to SDF, local anesthetic or other material component&#xD;
  &#xD;
            -  Subjects with ulcerative gingivitis or stomatitis&#xD;
  &#xD;
            -  Subjects with known sensitivity to silver or other heavy-metal ions&#xD;
  &#xD;
            -  Subjects showing abnormal skin sensitization in daily circumstances&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James Boynton, DDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James Boynton, DDS</last_name>
      <phone>734-763-2331</phone>
      <email>jboynton@umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>James R Boynton, DDS</last_name>
        <phone>734-764-1523</phone>
        <email>jboynton@umich.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>James R. Boynton</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Silver diamine fluoride</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Molar Hypomineralization</mesh_term>
      <mesh_term>Dental Enamel Hypoplasia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
      <mesh_term>Epinephrine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual Participant Data (IPD) is not planned to be shared.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964387
  org study id: HUM00228059
  nct id: NCT05964387
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The subject, care provider/outcomes assessor, and investigator will be blinded to which arm the tooth is randomized.
  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
  description: Four point scale evaluating efficacy of local anesthesia
  measure: Schiff Cold Air Sensitivity Scale
  time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
  description: Four point scale evaluating tooth sensitivity to cold
  measure: Face, Legs, Activity, Cry, Consolability (FLACC) Scale
  time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
  description: Three point scale evaluating five components of behavior and expression of discomfort in children
  arm group label: SDF
  arm group type: Experimental
  description: 38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
  intervention type: Device
  intervention name: SDF
  description: 38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
  arm group label: SDF
  other name: 2% lidocaine with 1:100,000 epinephrine
  intervention type: Device
  intervention name: Placebo
  description: An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 11 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: James Boynton, DDS
  role: Principal Investigator
  affiliation: University of Michigan
  last name: James Boynton, DDS
  phone: 734-763-2331
  email: jboynton@umich.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: James R. Boynton
  investigator title: Clinical Professor
  mesh term: Molar Hypomineralization
  mesh term: Dental Enamel Hypoplasia
  mesh term: Lidocaine
  mesh term: Epinephrine
  sharing ipd: No
  ipd description: Individual Participant Data (IPD) is not planned to be shared.