<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/NCT04471571</url>
  </required_header>
  <id_info>
    <org_study_id>DShehab</org_study_id>
    <nct_id>NCT04471571</nct_id>
  </id_info>
  <brief_title>Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors</brief_title>
  <official_title>A Comparison of the Effectiveness of Resin Infiltration Treatment Versus a Combined Treatment of Microabrasion and Resin Infiltration for the Management of Affected Incisors in Molar Incisor Hypomineralization (MIH) Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of molar incisor hypomineralization is relatively high. It has been reported&#xD;
      that MIH-affected children experience a wide range of negative impacts because of having&#xD;
      visible enamel opacities on their incisors whether these teeth show post eruptive breakdown&#xD;
      or not. The management of MIH is challenging with a broad spectrum of treatment modalities&#xD;
      being available. However, there are no clear guidelines available to aid in clinical decision&#xD;
      making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin&#xD;
      infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or&#xD;
      veneers. It is believed that these methods could be used alone or in a combination of methods&#xD;
      to achieve better aesthetic results.&#xD;
&#xD;
      For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment&#xD;
      options which could be used alone or in a combination. Accordingly, the aim of this study is&#xD;
      to compare the clinical outcomes of using resin infiltration either alone or combined with&#xD;
      microabrasion for the management of MIH affected incisors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry&#xD;
      and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The&#xD;
      primary hypothesis of this study is that a resin infiltration and microabrasion combined&#xD;
      treatment will result in better clinical outcomes than using resin infiltration alone. All&#xD;
      treatment procedures will be carried out by the principal investigator.&#xD;
&#xD;
      36 patients will be included in the study. The teeth will be randomized into two groups&#xD;
      according to the intervention. The study involves two types of interventions:&#xD;
&#xD;
      Group 1 (resin infiltration):&#xD;
&#xD;
      The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The&#xD;
      procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant.&#xD;
      Followed by removal of excess and then polishing of the treated surfaces.&#xD;
&#xD;
      Group 2 (Micro-abrasion followed by resin infiltration):&#xD;
&#xD;
      The Micro-abrasion agent (Opalustre, Ultradent, South Jordan, UT, USA) will be applied to the&#xD;
      tooth for 60 seconds using a standard rubber cup attached to a low speed hand piece followed&#xD;
      by rinsing the tooth surface with water for 20 seconds. This procedure will be repeated up to&#xD;
      5 times.&#xD;
&#xD;
      Resin infiltration will then be carried out as discussed before.&#xD;
&#xD;
      Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used&#xD;
      to evaluate the masking color of the teeth selected in the study.&#xD;
&#xD;
      Measurements will be taken before, immediately after, 1 month, 3 months, 6 months and 12&#xD;
      months after treatment.&#xD;
&#xD;
      A standardized Photograph will be taken at 5 different times (before treatment, immediately&#xD;
      afterwards, one month, 6 months and 12 months after treatment with the exact same camera and&#xD;
      conditions. The images collected will be analyzed and evaluated by 2 different dentists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</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>two-arm parallel group randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Selection bias: will be overcome by randomization and allocation concealment. Performance bias: will be overcome by standardized method of application by single operator.&#xD;
Detection bias: will be overcome by blinding of the outcome assessor. Reporting bias: All the outcomes will be reported and published.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the aesthetics and amount of color masking of the lesion</measure>
    <time_frame>12 months</time_frame>
    <description>Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14</measure>
    <time_frame>12 months</time_frame>
    <description>It includes evaluating the patient's Oral Health Related Quality of life (OHRQoL) before and after treatment which is measured as difference in the scores of the Child Perceptions Questionnaire CPQ 8-10/11-14 before and after treatment. There are 36 items included in the questionnaire covering four different domains: oral symptoms, function related limitations as well as emotional and social well-being. The participants should answer regarding the frequency of certain events in the last six months. There are 5 responses to choose from: 0 = Never, 1 = Once or twice, 2 = Sometimes, 3 = Often and 4 = Every day or almost every day. The total score should range from 0 to 144. Higher scores indicate low oral health related quality of life (OHRQoL).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <arm_group>
    <arm_group_label>Resin infiltration group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enamel lesions for this group will be treated only by resin infiltration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microabrasion + resin infiltration group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resin infiltration and microabrasion for MIH-affected incisors</intervention_name>
    <description>MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment</description>
    <arm_group_label>Microabrasion + resin infiltration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resin infiltration for MIH-affected incisors</intervention_name>
    <description>MIH-affected incisors will be treated with resin infiltration alone</description>
    <arm_group_label>Resin infiltration group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cooperative children aged between 7-16 years old&#xD;
&#xD;
          2. Children with MIH having enamel opacity involving at least one permanent incisor&#xD;
&#xD;
          3. MIH- affected incisors which did not receive any previous treatment&#xD;
&#xD;
          4. 1/3 of the crown should be visible in the oral cavity&#xD;
&#xD;
          5. Lesions size should be more than 1mm&#xD;
&#xD;
          6. Healthy children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children with systemic diseases, allergies or any dental or facial anomaly other than&#xD;
             MIH&#xD;
&#xD;
          2. Children aged &lt; 7 or &gt; 16 years old&#xD;
&#xD;
          3. Uncooperative children&#xD;
&#xD;
          4. MIH patients without the affection of the incisors or with compromised incisor&#xD;
             esthetics due to tooth surface loss, traumatic dental injury or caries&#xD;
&#xD;
          5. MIH incisors which already received any kind of treatment&#xD;
&#xD;
          6. Lesions which are smaller than 1mm in size&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shehab El-Din</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shehab El-Din</last_name>
    <phone>201066695543</phone>
    <email>dinanasrshehab@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.</citation>
    <PMID>30287963</PMID>
  </reference>
  <reference>
    <citation>Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.</citation>
    <PMID>30388743</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dina Shehab</investigator_full_name>
    <investigator_title>Assistant lecurer</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT04471571
org study id: DShehab
nct id: NCT04471571
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The prevalence of molar incisor hypomineralization is relatively high. It has been reported
      that MIH-affected children experience a wide range of negative impacts because of having
      visible enamel opacities on their incisors whether these teeth show post eruptive breakdown
      or not. The management of MIH is challenging with a broad spectrum of treatment modalities
      being available. However, there are no clear guidelines available to aid in clinical decision
      making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin
      infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or
      veneers. It is believed that these methods could be used alone or in a combination of methods
      to achieve better aesthetic results.

      For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment
      options which could be used alone or in a combination. Accordingly, the aim of this study is
      to compare the clinical outcomes of using resin infiltration either alone or combined with
      microabrasion for the management of MIH affected incisors.
The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry
      and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The
      primary hypothesis of this study is that a resin infiltration and microabrasion combined
      treatment will result in better clinical outcomes than using resin infiltration alone. All
      treatment procedures will be carried out by the principal investigator.

      36 patients will be included in the study. The teeth will be randomized into two groups
      according to the intervention. The study involves two types of interventions:

      Group 1 (resin infiltration):

      The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The
      procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant.
      Followed by removal of excess and then polishing of the treated surfaces.

      Group 2 (Micro-abrasion followed by resin infiltration):

      The Micro-abrasion agent (Opalustre, Ultradent, South Jordan, UT, USA) will be applied to the
      tooth for 60 seconds using a standard rubber cup attached to a low speed hand piece followed
      by rinsing the tooth surface with water for 20 seconds. This procedure will be repeated up to
      5 times.

      Resin infiltration will then be carried out as discussed before.

      Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used
      to evaluate the masking color of the teeth selected in the study.

      Measurements will be taken before, immediately after, 1 month, 3 months, 6 months and 12
      months after treatment.

      A standardized Photograph will be taken at 5 different times (before treatment, immediately
      afterwards, one month, 6 months and 12 months after treatment with the exact same camera and
      conditions. The images collected will be analyzed and evaluated by 2 different dentists.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two-arm parallel group randomized controlled trial
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Selection bias: will be overcome by randomization and allocation concealment. Performance bias: will be overcome by standardized method of application by single operator.
Detection bias: will be overcome by blinding of the outcome assessor. Reporting bias: All the outcomes will be reported and published.
measure: Change in the aesthetics and amount of color masking of the lesion
time frame: 12 months
description: Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.
measure: Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14
time frame: 12 months
description: It includes evaluating the patient's Oral Health Related Quality of life (OHRQoL) before and after treatment which is measured as difference in the scores of the Child Perceptions Questionnaire CPQ 8-10/11-14 before and after treatment. There are 36 items included in the questionnaire covering four different domains: oral symptoms, function related limitations as well as emotional and social well-being. The participants should answer regarding the frequency of certain events in the last six months. There are 5 responses to choose from: 0 = Never, 1 = Once or twice, 2 = Sometimes, 3 = Often and 4 = Every day or almost every day. The total score should range from 0 to 144. Higher scores indicate low oral health related quality of life (OHRQoL).
arm group label: Resin infiltration group
arm group type: Active Comparator
description: Enamel lesions for this group will be treated only by resin infiltration.
arm group label: Microabrasion + resin infiltration group
arm group type: Experimental
description: Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration.
intervention type: Other
intervention name: Resin infiltration and microabrasion for MIH-affected incisors
description: MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment
arm group label: Microabrasion + resin infiltration group
intervention type: Other
intervention name: Resin infiltration for MIH-affected incisors
description: MIH-affected incisors will be treated with resin infiltration alone
arm group label: Resin infiltration group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shehab El-Din
role: Principal Investigator
affiliation: Cairo University
last name: Shehab El-Din
phone: 201066695543
email: dinanasrshehab@hotmail.com
citation: Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.
PMID: 30287963
citation: Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.
PMID: 30388743
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dina Shehab
investigator title: Assistant lecurer
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia
sharing ipd: No