<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/NCT03770871</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2014-11-3</org_study_id>
    <nct_id>NCT03770871</nct_id>
  </id_info>
  <brief_title>Indirect Pulp Treatment in Primary Molars</brief_title>
  <acronym>RCT</acronym>
  <official_title>Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to evaluate the clinical and the radiographic success of Dycal and&#xD;
      Vitrebond as indirect pulp treatment materials in primary molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and&#xD;
      radiographically as indirect pulp treatment materials in deep caries in primary molars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 4</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>Parallel group with 1:1 allocation ratio</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cases reporting postoperative pain</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases reporting swelling</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases reporting sinus</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases reporting fistula</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cases reporting tooth mobility</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of cases reporting external root resorption</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases reporting internal root resorption</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases reporting furcation involvement</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases reporting widening of periodontal membrane space</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases reporting periapical radiolucency</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>IPT using Dycal (TM )</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPT using Vitrebond (TM )</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indirect pulp treatment using Dycal (TM)</intervention_name>
    <description>Partial caries removal and protection of the dental pulp with biocompatible material</description>
    <arm_group_label>IPT using Dycal (TM )</arm_group_label>
    <arm_group_label>IPT using Vitrebond (TM )</arm_group_label>
    <other_name>Indirect pulp capping</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indirect pulp treatment using Vitrebond (TM )</intervention_name>
    <description>Partial caries removal and protection of the dental pulp with biocompatible material</description>
    <arm_group_label>IPT using Dycal (TM )</arm_group_label>
    <arm_group_label>IPT using Vitrebond (TM )</arm_group_label>
    <other_name>Indirect pulp capping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        In compliance with AAPD, 2017 guidelines for pulp therapy &quot;IPT is indicated in a primary&#xD;
        tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not&#xD;
        removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria&#xD;
        to be vital and able to heal from the carious insult&quot;&#xD;
&#xD;
        In addition to:&#xD;
&#xD;
        I-Subjects:&#xD;
&#xD;
          1. Medically free children, their parent(s) accepts to sign the informed consent.&#xD;
&#xD;
          2. Age range from 4-8 years.&#xD;
&#xD;
        II-Molars:&#xD;
&#xD;
          1. Presence of at least 1 primary molar with deep carious lesion extending to more than&#xD;
             one half of the dentin on radiographic examination (to make the trial regardless of&#xD;
             number of carious molars).&#xD;
&#xD;
          2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).&#xD;
&#xD;
          3. Radiographically: Normal roots without physiological resorption, normal lamina dura&#xD;
             and normal periodontal membrane space (indicated for IPT).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        I-Subjects:&#xD;
&#xD;
          1. Uncooperative children.&#xD;
&#xD;
          2. Parents unable to attend follow up visits (even after explaining the importance of&#xD;
             recall visits).&#xD;
&#xD;
        II-Molars:&#xD;
&#xD;
          1. History of spontaneous pain (to exclude reversible pulpitis).&#xD;
&#xD;
          2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non&#xD;
             vital teeth).&#xD;
&#xD;
          3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or&#xD;
             external or internal resorption (to exclude teeth not indicated for IPT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shereen E Taha, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Farouk Rashed</investigator_full_name>
    <investigator_title>Researcher assisstant</investigator_title>
  </responsible_party>
  <keyword>indirect pulp</keyword>
  <keyword>primary</keyword>
  <keyword>calcium hydroxide</keyword>
  <keyword>resin modified glass ionomer</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>final results</ipd_description>
  </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/NCT03770871
org study id: CEBD-CU-2014-11-3
nct id: NCT03770871
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study was conducted to evaluate the clinical and the radiographic success of Dycal and
      Vitrebond as indirect pulp treatment materials in primary molars.
Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and
      radiographically as indirect pulp treatment materials in deep caries in primary molars.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel group with 1:1 allocation ratio
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double blinded
measure: Number of cases reporting postoperative pain
time frame: 12 months
description: Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
measure: Number of cases reporting swelling
time frame: 12 months
description: Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
measure: Number of cases reporting sinus
time frame: 12 months
description: Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
measure: Number of cases reporting fistula
time frame: 12 months
description: Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
measure: Number of cases reporting tooth mobility
time frame: 12 months
description: Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
measure: Number of cases reporting external root resorption
time frame: 12 months
description: Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
measure: Number of cases reporting internal root resorption
time frame: 12 months
description: Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
measure: Number of cases reporting furcation involvement
time frame: 12 months
description: Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
measure: Number of cases reporting widening of periodontal membrane space
time frame: 12 months
description: Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
measure: Number of cases reporting periapical radiolucency
time frame: 12 months
description: Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
arm group label: IPT using Dycal (TM )
arm group type: Active Comparator
description: Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
arm group label: IPT using Vitrebond (TM )
arm group type: Experimental
description: Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
intervention type: Drug
intervention name: Indirect pulp treatment using Dycal (TM)
description: Partial caries removal and protection of the dental pulp with biocompatible material
arm group label: IPT using Dycal (TM )
arm group label: IPT using Vitrebond (TM )
other name: Indirect pulp capping
intervention type: Drug
intervention name: Indirect pulp treatment using Vitrebond (TM )
description: Partial caries removal and protection of the dental pulp with biocompatible material
arm group label: IPT using Dycal (TM )
arm group label: IPT using Vitrebond (TM )
other name: Indirect pulp capping
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shereen E Taha, Professor
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Farouk Rashed
investigator title: Researcher assisstant
mesh term: Dental Caries
sharing ipd: No
ipd description: final results