<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/NCT03229707</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-07-17</org_study_id>
    <nct_id>NCT03229707</nct_id>
  </id_info>
  <brief_title>Impact Of Digital Photography &amp; Conventional Method On The Accuracy Of Dental Shade Matching In The Esthetic Zone</brief_title>
  <official_title>Impact Of Digital Photography &amp; Conventional Method On The Accuracy Of Shade Matching In The Esthetic Zone</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study:&#xD;
&#xD;
      Is to evaluate the accuracy of digital photography in optimizing shade matching when compared&#xD;
      to conventional method of shade selection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D&#xD;
      master, using modified (USPHS) criteria Group 2: Color matching using digital photography&#xD;
      using (Photoshop adopt) the assessment will be through a questionnaire for the patient&#xD;
      satisfaction outcome using Visual analogue scale&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 year</time_frame>
    <description>Visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Color Matching</measure>
    <time_frame>1 year</time_frame>
    <description>Digital Photography using (Photoshop)/using Vita 3D master Modified (USPHS) criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Accuracy of Dental Shade Selection in the Aesthetic Zone</condition>
  <arm_group>
    <arm_group_label>group 1 Color matching using Vita 3D master</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Outcome Name: Color Matching measured by :&#xD;
Modified (USPHS) criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 Color matching using digital photography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Outcome Name: Color Matching measured by Digital Photography using (Photoshop)&#xD;
Software:&#xD;
0 to 1: no difference in perception&#xD;
1 to 2: only perceptible to a trained observer&#xD;
2 to 3.5: perceptible difference&#xD;
3.5 to 5: marked difference</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Digital photography using software Photoshop</intervention_name>
    <description>When taking the image, a gray card is used for subsequent exposure calibration in Adobe Camera Raw (which is packaged with Photoshop).&#xD;
Images are then opened into Photoshop.&#xD;
The &quot;INFO&quot; panel must be open.&#xD;
Click on the small eyedropper in the Info panel window and click on ''Lab Color&quot;.&#xD;
Place the mouse over the center of the tooth to be measured for L value.&#xD;
Click on the &quot;HSB Color&quot; option, which stands for hue, saturation, and brightness.</description>
    <arm_group_label>group 2 Color matching using digital photography</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vita 3D master shade guide</intervention_name>
    <description>Alpha (A)Perfectly matched Beta (B)Not perfectly matched Charlie (C)unacceptable Determent by 10 observers</description>
    <arm_group_label>group 1 Color matching using Vita 3D master</arm_group_label>
    <other_name>Conventional shade matching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients between 18-70 years old, able to read and sign the informed consent document.&#xD;
&#xD;
          2. Patients requiring restorations in the esthetic zone.&#xD;
&#xD;
          3. Patients don't have active periodontal or pulpal diseases&#xD;
&#xD;
          4. Patients willing to return for follow-up examination and evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients in the growth stage.&#xD;
&#xD;
          2. Patients with poor oral hygiene and lack of motivation.&#xD;
&#xD;
          3. Psychiatric problems or unrealistic expectations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rawan Ferroukhi, Masters in FixedProsthodontics</last_name>
    <role>Principal Investigator</role>
    <affiliation>MSc Student of Fixed Prosthodontics, Division of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.actascientific.com/ASDS/pdf/ASDS-04-0945.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Rawan Ferroukhi</investigator_full_name>
    <investigator_title>Master Student</investigator_title>
  </responsible_party>
  <!-- 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/NCT03229707
org study id: CEBC-CU-2017-07-17
nct id: NCT03229707
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study:

      Is to evaluate the accuracy of digital photography in optimizing shade matching when compared
      to conventional method of shade selection.
Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D
      master, using modified (USPHS) criteria Group 2: Color matching using digital photography
      using (Photoshop adopt) the assessment will be through a questionnaire for the patient
      satisfaction outcome using Visual analogue scale
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: Patient satisfaction
time frame: 1 year
description: Visual analogue scale
measure: Color Matching
time frame: 1 year
description: Digital Photography using (Photoshop)/using Vita 3D master Modified (USPHS) criteria
arm group label: group 1 Color matching using Vita 3D master
arm group type: Active Comparator
description: Outcome Name: Color Matching measured by :
Modified (USPHS) criteria
arm group label: group 2 Color matching using digital photography
arm group type: Experimental
description: Outcome Name: Color Matching measured by Digital Photography using (Photoshop)
Software:
0 to 1: no difference in perception
1 to 2: only perceptible to a trained observer
2 to 3.5: perceptible difference
3.5 to 5: marked difference
intervention type: Device
intervention name: Digital photography using software Photoshop
description: When taking the image, a gray card is used for subsequent exposure calibration in Adobe Camera Raw (which is packaged with Photoshop).
Images are then opened into Photoshop.
The "INFO" panel must be open.
Click on the small eyedropper in the Info panel window and click on ''Lab Color".
Place the mouse over the center of the tooth to be measured for L value.
Click on the "HSB Color" option, which stands for hue, saturation, and brightness.
arm group label: group 2 Color matching using digital photography
intervention type: Device
intervention name: Vita 3D master shade guide
description: Alpha (A)Perfectly matched Beta (B)Not perfectly matched Charlie (C)unacceptable Determent by 10 observers
arm group label: group 1 Color matching using Vita 3D master
other name: Conventional shade matching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rawan Ferroukhi, Masters in FixedProsthodontics
role: Principal Investigator
affiliation: MSc Student of Fixed Prosthodontics, Division of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt
facility: 
country: Egypt
url: https://www.actascientific.com/ASDS/pdf/ASDS-04-0945.pdf
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Rawan Ferroukhi
investigator title: Master Student