<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/NCT03760497</url>
  </required_header>
  <id_info>
    <org_study_id>MIHFORPUSP</org_study_id>
    <nct_id>NCT03760497</nct_id>
  </id_info>
  <brief_title>Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study</brief_title>
  <official_title>Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of&#xD;
      systemic origin, which affects one or more permanent first molars, and may or may not involve&#xD;
      permanent incisors. MIH has several clinical repercussions, such as presence of&#xD;
      hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among&#xD;
      others, making it difficult to perform dental treatment. Therefore, the present study will&#xD;
      evaluate, through a randomized controlled clinical study, three restorative protocols for the&#xD;
      treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The&#xD;
      following groups will be evaluated: direct restoration with composite resin; restoration with&#xD;
      composite resin with diode laser application and temporary restoration with glass ionomer&#xD;
      cement followed by restoration with composite resin). The restorations will be evaluated&#xD;
      after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration&#xD;
      longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such&#xD;
      as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin&#xD;
      sensitivity and impact on participants' quality of life, as well as the duration and cost of&#xD;
      treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel&#xD;
      statistical analyzes will be performed to verify the effectiveness of diode laser treatment&#xD;
      compared to sealing, in addition to possible factors associated with this efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Longevity of restorations</measure>
    <time_frame>24 months.</time_frame>
    <description>The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols.&#xD;
Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment satisfaction as assessed by VAS scale (Index 0 to 10)</measure>
    <time_frame>After 1 week of treatment, 1, 12 and 24 months.</time_frame>
    <description>After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)</measure>
    <time_frame>On treatment day</time_frame>
    <description>In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)</measure>
    <time_frame>On treatment day</time_frame>
    <description>To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Assessment</measure>
    <time_frame>On treatment day</time_frame>
    <description>For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Socioeconomic questionnaire</measure>
    <time_frame>On treatment day</time_frame>
    <description>Information obtained through a socioeconomic questionnaire and questions related to the individual characteristics of the child, such as, for example, fluoride exposure variables, oral hygiene practices and eating habits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the caries experience</measure>
    <time_frame>On treatment day</time_frame>
    <description>Evaluation of the caries experience by the ceo-d / CPO-D indices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of biofilm visible</measure>
    <time_frame>On treatment day</time_frame>
    <description>Presence of biofilm visible through the Simplified Oral Hygiene Index in which six surfaces will be used to represent the entire mouth: the vestibular of the first right and left first molars, the lingual of the first right and left first molars, and the vestibular surface of the upper central incisor right and bottom left</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the visible biofilm accumulated on the occlusal surface</measure>
    <time_frame>On treatment day</time_frame>
    <description>First the presence of dental biofilm will be evaluated visually, according to the following index: 0: absence of visible biofilm; 1: visible but difficult to identify biofilm - best verified after drying; 2: Visible and easily identifiable biofilm - even without drying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated</measure>
    <time_frame>On treatment day</time_frame>
    <description>0: absence of visible biofilm, 1: biofilm not visible, but removed from the gingival sulcus with the periodontal probe; 2: visible biofilm after drying; 3: abundant biofilm, visible even without drying.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of eruption degree</measure>
    <time_frame>On treatment day</time_frame>
    <description>The degree of eruption will be assessed according to the following criteria (5): A: not erupted or less than 1/3 of the erupted occlusal surface or part of the crown of the visible incisor; B: totally erupted or at least 1/3, but less than the total occlusal surface erupted and / or less than the total crown length of the visible incisor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of lesion extension</measure>
    <time_frame>On treatment day</time_frame>
    <description>The extent of lesion will be evaluated according to the following criterion (5): I: less than one third of the affected tooth, II: at least 1/3 of the affected tooth, but less than 2/3, III : at least 2/3 of the affected tooth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of procedures</measure>
    <time_frame>On treatment day</time_frame>
    <description>To calculate the direct costs of the procedures, the time spent in each consultation (initials and reevaluations) will be taken into account. The time will be timed and recorded in a specific clinical record. For the calculation of direct costs, the prices of consumer and permanent materials (specifications and quantity) used in each procedure, electricity and the professional fee will be considered. These values will be inferences of the market value obtained by average of different places that market the products in question, being updated during the time of the study. In addition, the cost of equipment depreciation and electricity will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <arm_group>
    <arm_group_label>CIV Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Temporary Restoration with Glass Ionomer (Equia Forte® - GC Corporation, Tokyo, Japan) for 30 days + Restoration in Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Composite Resin Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restoration with Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, United States).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Composite Resin Group + Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Composite Resin Restoration (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA) + Application of Diode Laser.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restorative treatment</intervention_name>
    <description>For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.</description>
    <arm_group_label>CIV Group</arm_group_label>
    <arm_group_label>Composite Resin Group</arm_group_label>
    <arm_group_label>Composite Resin Group + Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - At least one permanent first molar with occlusal surface with severe MIH grade (with post&#xD;
        eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in&#xD;
        the selected tooth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Dentistry of Ribeirao Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14040-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernanda Vicioni Marques, pHD Student</last_name>
      <phone>+55 16 999936791</phone>
      <email>fernanda.vicioni.marques@usp.br</email>
    </contact>
    <investigator>
      <last_name>Fabrício Kitazono de Carvalho, Professor Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Vicioni-Marques, F</investigator_full_name>
    <investigator_title>Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study</investigator_title>
  </responsible_party>
  <keyword>Lasers</keyword>
  <keyword>Hipomineralization of dental enamel</keyword>
  <keyword>Preventive dentistry</keyword>
  <keyword>Glass ionomer cement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molar Hypomineralization</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03760497
org study id: MIHFORPUSP
nct id: NCT03760497
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of
      systemic origin, which affects one or more permanent first molars, and may or may not involve
      permanent incisors. MIH has several clinical repercussions, such as presence of
      hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among
      others, making it difficult to perform dental treatment. Therefore, the present study will
      evaluate, through a randomized controlled clinical study, three restorative protocols for the
      treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The
      following groups will be evaluated: direct restoration with composite resin; restoration with
      composite resin with diode laser application and temporary restoration with glass ionomer
      cement followed by restoration with composite resin). The restorations will be evaluated
      after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration
      longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such
      as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin
      sensitivity and impact on participants' quality of life, as well as the duration and cost of
      treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel
      statistical analyzes will be performed to verify the effectiveness of diode laser treatment
      compared to sealing, in addition to possible factors associated with this efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Longevity of restorations
time frame: 24 months.
description: The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols.
Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.
measure: Treatment satisfaction as assessed by VAS scale (Index 0 to 10)
time frame: After 1 week of treatment, 1, 12 and 24 months.
description: After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.
measure: Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)
time frame: On treatment day
description: In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.
measure: Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)
time frame: On treatment day
description: To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.
measure: Anxiety Assessment
time frame: On treatment day
description: For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used
measure: Socioeconomic questionnaire
time frame: On treatment day
description: Information obtained through a socioeconomic questionnaire and questions related to the individual characteristics of the child, such as, for example, fluoride exposure variables, oral hygiene practices and eating habits.
measure: Evaluation of the caries experience
time frame: On treatment day
description: Evaluation of the caries experience by the ceo-d / CPO-D indices
measure: Presence of biofilm visible
time frame: On treatment day
description: Presence of biofilm visible through the Simplified Oral Hygiene Index in which six surfaces will be used to represent the entire mouth: the vestibular of the first right and left first molars, the lingual of the first right and left first molars, and the vestibular surface of the upper central incisor right and bottom left
measure: Evaluation of the visible biofilm accumulated on the occlusal surface
time frame: On treatment day
description: First the presence of dental biofilm will be evaluated visually, according to the following index: 0: absence of visible biofilm; 1: visible but difficult to identify biofilm - best verified after drying; 2: Visible and easily identifiable biofilm - even without drying
measure: Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated
time frame: On treatment day
description: 0: absence of visible biofilm, 1: biofilm not visible, but removed from the gingival sulcus with the periodontal probe; 2: visible biofilm after drying; 3: abundant biofilm, visible even without drying.
measure: Assessment of eruption degree
time frame: On treatment day
description: The degree of eruption will be assessed according to the following criteria (5): A: not erupted or less than 1/3 of the erupted occlusal surface or part of the crown of the visible incisor; B: totally erupted or at least 1/3, but less than the total occlusal surface erupted and / or less than the total crown length of the visible incisor.
measure: Evaluation of lesion extension
time frame: On treatment day
description: The extent of lesion will be evaluated according to the following criterion (5): I: less than one third of the affected tooth, II: at least 1/3 of the affected tooth, but less than 2/3, III : at least 2/3 of the affected tooth.
measure: Cost of procedures
time frame: On treatment day
description: To calculate the direct costs of the procedures, the time spent in each consultation (initials and reevaluations) will be taken into account. The time will be timed and recorded in a specific clinical record. For the calculation of direct costs, the prices of consumer and permanent materials (specifications and quantity) used in each procedure, electricity and the professional fee will be considered. These values will be inferences of the market value obtained by average of different places that market the products in question, being updated during the time of the study. In addition, the cost of equipment depreciation and electricity will be calculated.
arm group label: CIV Group
arm group type: Experimental
description: Temporary Restoration with Glass Ionomer (Equia Forte® - GC Corporation, Tokyo, Japan) for 30 days + Restoration in Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA).
arm group label: Composite Resin Group
arm group type: Experimental
description: Restoration with Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, United States).
arm group label: Composite Resin Group + Laser
arm group type: Experimental
description: Composite Resin Restoration (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA) + Application of Diode Laser.
intervention type: Procedure
intervention name: Restorative treatment
description: For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.
arm group label: CIV Group
arm group label: Composite Resin Group
arm group label: Composite Resin Group + Laser
criteria: 
gender: All
minimum age: 6 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Vicioni-Marques, F
investigator title: Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study
mesh term: Molar Hypomineralization
sharing ipd: Undecided