<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/NCT02994862</url>
  </required_header>
  <id_info>
    <org_study_id>1226500339</org_study_id>
    <nct_id>NCT02994862</nct_id>
  </id_info>
  <brief_title>E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent</brief_title>
  <official_title>One Year Clinical Evaluation of E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent Before Bonding to Teeth With Amelogenesis Imperfecta</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla&#xD;
      chinensis before Bonding of laminate veneers with adhesive resin cement provide better&#xD;
      survival rate than conventional Bonding method&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will&#xD;
      application of galla chinensis before Bonding of laminate veneers with adhesive resin cement&#xD;
      provide better survival rate than conventional Bonding method&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>marginal adaptation assessed by clinical evaluation using dental mirror and probe</measure>
    <time_frame>1 year</time_frame>
    <description>clinical evaluation of marginal adaptation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction assessed using a Questionnaire</measure>
    <time_frame>1 Year</time_frame>
    <description>Questionnaire for patient satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Amelogenesis Imperfecta</condition>
  <arm_group>
    <arm_group_label>Galla Chinnesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Bonding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal Bonding Method</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Galla Chinnesis</intervention_name>
    <description>new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta</description>
    <arm_group_label>Galla Chinnesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Bonding</intervention_name>
    <description>Normal Bonding Protocol</description>
    <arm_group_label>Conventional Bonding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects are required to be:&#xD;
&#xD;
          -  From 18-60 years old, and able to read and sign the informed consent document.&#xD;
&#xD;
          -  Physically and psychologically able to tolerate conventional restorative procedures&#xD;
&#xD;
          -  Have no active periodontal or pulpal diseases, have teeth with good restorations&#xD;
&#xD;
          -  Patients with teeth problems indicated for laminate veneer (e.g. discoloration,&#xD;
             fracture not involve more than 50% enamel loss, mild malposition, ….)&#xD;
&#xD;
          -  Willing to return for follow-up examinations and evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in the growth stage with partially erupted teeth&#xD;
&#xD;
          -  Patient with fractured teeth of more than 50% enamel loss&#xD;
&#xD;
          -  Patients with poor oral hygiene and motivation&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Psychiatric problems or unrealistic expectations&#xD;
&#xD;
          -  Lack of opposite occluding dentition in the area intended for restoration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammed mohammed, B.D.S</last_name>
    <phone>01226500339</phone>
    <email>mgamal400@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jylan Elguindy, Phd</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.</citation>
    <PMID>20690414</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Gamal Fahmy Mohammed</investigator_full_name>
    <investigator_title>B.D.S</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amelogenesis Imperfecta</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/NCT02994862
org study id: 1226500339
nct id: NCT02994862
lead sponsor: 
has dmc: No
In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla
      chinensis before Bonding of laminate veneers with adhesive resin cement provide better
      survival rate than conventional Bonding method
one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will
      application of galla chinensis before Bonding of laminate veneers with adhesive resin cement
      provide better survival rate than conventional Bonding method
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: marginal adaptation assessed by clinical evaluation using dental mirror and probe
time frame: 1 year
description: clinical evaluation of marginal adaptation
measure: Patient satisfaction assessed using a Questionnaire
time frame: 1 Year
description: Questionnaire for patient satisfaction
arm group label: Galla Chinnesis
arm group type: Experimental
description: new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
arm group label: Conventional Bonding
arm group type: Active Comparator
description: Normal Bonding Method
intervention type: Other
intervention name: Galla Chinnesis
description: new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
arm group label: Galla Chinnesis
intervention type: Other
intervention name: Conventional Bonding
description: Normal Bonding Protocol
arm group label: Conventional Bonding
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mohammed mohammed, B.D.S
phone: 01226500339
email: mgamal400@gmail.com
last name: Jylan Elguindy, Phd
citation: Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.
PMID: 20690414
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Gamal Fahmy Mohammed
investigator title: B.D.S
mesh term: Amelogenesis Imperfecta
sharing ipd: Undecided