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/NCT06003257</url>
    </required_header>
    <id_info>
      <org_study_id>286/2020</org_study_id>
      <nct_id>NCT06003257</nct_id>
    </id_info>
    <brief_title>Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns for Deciduous Molars</brief_title>
    <official_title>Comparison Between Stainless-Steel, Zirconia and Fiberglass Crowns as Full Coverage Restoration for Deciduous Molars of Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suez Canal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suez Canal University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will be divided into two parts: In vivo part and in vitro part.In vivo part: It&#xD;
        will be a randomized clinical trial using split mouth technique on 44 primary molars in&#xD;
        children aged from 4-8 years old selected from outpatient clinic of Department of Pediatric&#xD;
        Dentistry, Faculty of Dentistry, Suez Canal University. The selected primary molars will be&#xD;
        divided randomly into two main groups ,each group will be subdivided into two subgroups&#xD;
        according to types of crowns that will be used as follows:- Group I:- comprise of 22 primary&#xD;
        molars that will be subdivided into two subgroups, subgroup IA:-includes 11 primary molars&#xD;
        will be restored by stainless steel crowns and subgroup IB:-includes 11 primary molars will&#xD;
        be restored by zirconia crowns, Group II:- comprise of 22 primary molars that will be&#xD;
        subdivided into two subgroups, subgroup IIA:-includes 11 primary molars will be restored by&#xD;
        stainless steel crowns and subgroup IIB:-includes 11 primary molars will be restored by&#xD;
        fiberglass crowns. The three types of crowns will be evaluated at the baseline once after&#xD;
        cementation of the crowns and after one week,1 ,3,6,9 and 12 months follow up by using the&#xD;
        following methods modified United States Public Health Service criteria, in terms of color&#xD;
        match, marginal integrity, secondary caries and crown fracture, the gingival marginal status&#xD;
        and parental satisfaction. In vitro part: It will be carried out on 30 mandibular primary&#xD;
        molars, 15 mandibular first primary molars for microleakage test and 15 mandibular second&#xD;
        primary molars for crown fracture resistance test for three crowns types.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be a randomized clinical trial using split mouth technique on 44 primary&#xD;
        molars in children aged from 4-8 years old selected from outpatient Clinic of Department of&#xD;
        Pediatric Dentistry, Faculty of Dentistry, Suez Canal University after approval of Research&#xD;
        Ethics Committee (REC) of the Faculty of Dentistry, Suez Canal University. The children&#xD;
        participants and legal guardian of each participant will be assigned on informed consent of&#xD;
        treatment procedures they will receive.&#xD;
  &#xD;
        A total of 44 primary molars will be included in this study using split mouth technique to&#xD;
        ensure equalizing variables for both groups.&#xD;
  &#xD;
        The selected primary molars will be divided randomly into two main groups, each group will be&#xD;
        subdivided into two subgroups according to types of crowns that will be used as follows: -&#xD;
  &#xD;
          -  Group I: comprise of 22 primary molars that will be subdivided into two subgroups:&#xD;
  &#xD;
               -  Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.&#xD;
  &#xD;
               -  Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.&#xD;
  &#xD;
          -  Group II: comprise of 22 primary molars that will be subdivided into two subgroups:&#xD;
  &#xD;
               -  Subgroup IIA: includes 11 primary molars will be restored by stainless steel&#xD;
                  crowns.&#xD;
  &#xD;
               -  Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.&#xD;
  &#xD;
        II.4 Clinical Procedures:&#xD;
  &#xD;
          -  Eligibility criteria will be verified after the clinical and periapical radiographic&#xD;
             examination.&#xD;
  &#xD;
          -  The selected primary molars will be anesthetized to reduce discomfort during&#xD;
             preparation.&#xD;
  &#xD;
          -  Tooth preparation and crown cementation will be performed for each tooth according to&#xD;
             the manufacture's instruction for each type of crowns.&#xD;
  &#xD;
        II.5 Methods of evaluation:&#xD;
  &#xD;
        The evaluation of each crown will be assessed at the baseline once after cementation and&#xD;
        after one week,1, 3, 6,9 and 12 months follow up by using the following methods:&#xD;
  &#xD;
        II.5.1 Modified United States Public Health Service (USPHS) criteria:&#xD;
  &#xD;
        Modified United States Public Health Service (USPHS) criteria will be used in terms of&#xD;
        marginal integrity, secondary caries, color match, and crown fracture&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 23, 2022</start_date>
    <completion_date type="Actual">May 13, 2023</completion_date>
    <primary_completion_date type="Actual">March 28, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Group I: comprise of 22 primary molars that will be subdivided into two subgroups:&#xD;
  Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.&#xD;
  Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.&#xD;
  Group II: comprise of 22 primary molars that will be subdivided into two subgroups:&#xD;
  Subgroup IIA: includes 11 primary molars will be restored by stainless steel crowns.&#xD;
  Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical performance &quot; marginal integrity, color change, secondary caries and crown fractures&quot;</measure>
      <time_frame>immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months</time_frame>
      <description>Modified United States Public Health Service (USPHS) criteria will be used in terms of marginal integrity, secondary caries, color match, and crown fracture</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measuring of gingival marginal status</measure>
      <time_frame>immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months</time_frame>
      <description>The gingival marginal status will be assessed by the plaque index (PI) and gingival index where 0 normal gingiva and no plaque while 3 severe inflammation and abudance of soft matter within gingival pocket</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measuring of parental satisfaction</measure>
      <time_frame>immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months</time_frame>
      <description>Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction. parents will ask to rate parameters such as the crown's shape, size, color, and their overall satisfaction by using Parental satisfactions questionnaire</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">44</enrollment>
    <condition>Caries of Infancy</condition>
    <arm_group>
      <arm_group_label>primary molars will be restored by stainless steel crowns</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>primary molars will be restored by zirconia crowns</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>primary molars will be restored by fiberglass crowns.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>stainless steel crown</intervention_name>
      <description>stainless steel full coverage crown for deciduous teeth</description>
      <arm_group_label>primary molars will be restored by stainless steel crowns</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>zirconia crown</intervention_name>
      <description>zirconia full coverage crown for deciduous teeth</description>
      <arm_group_label>primary molars will be restored by zirconia crowns</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fiberglass crown</intervention_name>
      <description>fiberglass full coverage crown for deciduous teeth</description>
      <arm_group_label>primary molars will be restored by fiberglass crowns.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Apparently healthy children free from any systemic diseases. 2. Patient within the&#xD;
               age group of 4 to 8 years old of both sexes. 3. Cooperative patient. 4. Patient with&#xD;
               at least two bilateral primary molars indicated for full coverage as follows:&#xD;
  &#xD;
                 1. Multi-surfaces caries more than two surfaces&#xD;
  &#xD;
                 2. Pulp therapy treated primary molars&#xD;
  &#xD;
                 3. Developmental defects on tooth surface&#xD;
  &#xD;
                 4. Root resorption less than/ equal to1/3rd of root length 5. Parent willing to&#xD;
                    participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with primary molars have the following criteria:&#xD;
  &#xD;
                 1. Acute infection&#xD;
  &#xD;
                 2. Infra-occlusion&#xD;
  &#xD;
                 3. Mobility&#xD;
  &#xD;
                 4. Internal root resorption&#xD;
  &#xD;
                 5. Exfoliation imminent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>faculty of dentistry Suez canal university</name>
        <address>
          <city>Ismailia</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06003257
  org study id: 286/2020
  nct id: NCT06003257
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study will be divided into two parts: In vivo part and in vitro part.In vivo part: It
        will be a randomized clinical trial using split mouth technique on 44 primary molars in
        children aged from 4-8 years old selected from outpatient clinic of Department of Pediatric
        Dentistry, Faculty of Dentistry, Suez Canal University. The selected primary molars will be
        divided randomly into two main groups ,each group will be subdivided into two subgroups
        according to types of crowns that will be used as follows:- Group I:- comprise of 22 primary
        molars that will be subdivided into two subgroups, subgroup IA:-includes 11 primary molars
        will be restored by stainless steel crowns and subgroup IB:-includes 11 primary molars will
        be restored by zirconia crowns, Group II:- comprise of 22 primary molars that will be
        subdivided into two subgroups, subgroup IIA:-includes 11 primary molars will be restored by
        stainless steel crowns and subgroup IIB:-includes 11 primary molars will be restored by
        fiberglass crowns. The three types of crowns will be evaluated at the baseline once after
        cementation of the crowns and after one week,1 ,3,6,9 and 12 months follow up by using the
        following methods modified United States Public Health Service criteria, in terms of color
        match, marginal integrity, secondary caries and crown fracture, the gingival marginal status
        and parental satisfaction. In vitro part: It will be carried out on 30 mandibular primary
        molars, 15 mandibular first primary molars for microleakage test and 15 mandibular second
        primary molars for crown fracture resistance test for three crowns types.
  The study will be a randomized clinical trial using split mouth technique on 44 primary
        molars in children aged from 4-8 years old selected from outpatient Clinic of Department of
        Pediatric Dentistry, Faculty of Dentistry, Suez Canal University after approval of Research
        Ethics Committee (REC) of the Faculty of Dentistry, Suez Canal University. The children
        participants and legal guardian of each participant will be assigned on informed consent of
        treatment procedures they will receive.
  
        A total of 44 primary molars will be included in this study using split mouth technique to
        ensure equalizing variables for both groups.
  
        The selected primary molars will be divided randomly into two main groups, each group will be
        subdivided into two subgroups according to types of crowns that will be used as follows: -
  
          -  Group I: comprise of 22 primary molars that will be subdivided into two subgroups:
  
               -  Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.
  
               -  Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.
  
          -  Group II: comprise of 22 primary molars that will be subdivided into two subgroups:
  
               -  Subgroup IIA: includes 11 primary molars will be restored by stainless steel
                  crowns.
  
               -  Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.
  
        II.4 Clinical Procedures:
  
          -  Eligibility criteria will be verified after the clinical and periapical radiographic
             examination.
  
          -  The selected primary molars will be anesthetized to reduce discomfort during
             preparation.
  
          -  Tooth preparation and crown cementation will be performed for each tooth according to
             the manufacture's instruction for each type of crowns.
  
        II.5 Methods of evaluation:
  
        The evaluation of each crown will be assessed at the baseline once after cementation and
        after one week,1, 3, 6,9 and 12 months follow up by using the following methods:
  
        II.5.1 Modified United States Public Health Service (USPHS) criteria:
  
        Modified United States Public Health Service (USPHS) criteria will be used in terms of
        marginal integrity, secondary caries, color match, and crown fracture
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Group I: comprise of 22 primary molars that will be subdivided into two subgroups:
  Subgroup IA: includes 11 primary molars will be restored by stainless steel crowns.
  Subgroup IB: includes 11 primary molars will be restored by zirconia crowns.
  Group II: comprise of 22 primary molars that will be subdivided into two subgroups:
  Subgroup IIA: includes 11 primary molars will be restored by stainless steel crowns.
  Subgroup IIB: includes 11 primary molars will be restored by fiberglass crowns.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: clinical performance " marginal integrity, color change, secondary caries and crown fractures"
  time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
  description: Modified United States Public Health Service (USPHS) criteria will be used in terms of marginal integrity, secondary caries, color match, and crown fracture
  measure: Measuring of gingival marginal status
  time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
  description: The gingival marginal status will be assessed by the plaque index (PI) and gingival index where 0 normal gingiva and no plaque while 3 severe inflammation and abudance of soft matter within gingival pocket
  measure: Measuring of parental satisfaction
  time frame: immediately after cementation, after 1 month, 3 months, 6 months, 9 months and 12 months
  description: Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction. parents will ask to rate parameters such as the crown's shape, size, color, and their overall satisfaction by using Parental satisfactions questionnaire
  arm group label: primary molars will be restored by stainless steel crowns
  arm group type: Active Comparator
  arm group label: primary molars will be restored by zirconia crowns
  arm group type: Active Comparator
  arm group label: primary molars will be restored by fiberglass crowns.
  arm group type: Active Comparator
  intervention type: Other
  intervention name: stainless steel crown
  description: stainless steel full coverage crown for deciduous teeth
  arm group label: primary molars will be restored by stainless steel crowns
  intervention type: Other
  intervention name: zirconia crown
  description: zirconia full coverage crown for deciduous teeth
  arm group label: primary molars will be restored by zirconia crowns
  intervention type: Other
  intervention name: fiberglass crown
  description: fiberglass full coverage crown for deciduous teeth
  arm group label: primary molars will be restored by fiberglass crowns.
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor
  sharing ipd: No