<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/NCT04463342</url>
  </required_header>
  <id_info>
    <org_study_id>CairoU-MMEldamanhoury</org_study_id>
    <nct_id>NCT04463342</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth</brief_title>
  <official_title>Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: 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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with occlusal caries in posterior teeth, does the use of recently introduced non&#xD;
      coated glass ionomer provide better clinical performance compared to conventional glass&#xD;
      ionomer with surface coating?&#xD;
&#xD;
      -Primary objective: To evaluate clinical performance of different types of restorations&#xD;
      (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries&#xD;
      in posterior teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo&#xD;
      University; The operator in charge will be Mahmoud Magdy Eldamanhory&#xD;
&#xD;
      Patients will be selected from the outpatient clinic of the department Conservative Dentistry&#xD;
      Department, Faculty of Dentistry, Cairo University&#xD;
&#xD;
        -  Local anesthesia will be applied to patients complaining about pain or sensitivity to&#xD;
           prevent discomfort during restorative procedures.&#xD;
&#xD;
        -  Conservative cavity design will be used according to the principals of minimal invasive&#xD;
           dentistry.&#xD;
&#xD;
        -  All the cavities will be performed by the main author using #57 straight plain carbide&#xD;
           fissure bur held in high speed contra-angled hand piece with water cooling system.&#xD;
&#xD;
        -  All internal line angles will be slightly rounded.&#xD;
&#xD;
        -  Each bur will be discarded after 5 preparations&#xD;
&#xD;
        -  If deep caries will be found, it will be removed with large round bur at low speed and a&#xD;
           thin layer of calcium hydroxide will be placed on the deep portion of the cavity.&#xD;
&#xD;
        -  Isolation will be maintained by using Rubber Dam.&#xD;
&#xD;
        -  The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20&#xD;
           seconds (Cavity Conditioner, GC), washed, and briefly dried.&#xD;
&#xD;
        -  The restorations will inject into the cavity.&#xD;
&#xD;
        -  After the passage of the manufacturer's recommended setting time of 2.5 minutes, the&#xD;
           restoration will be trimmed and polished wet using high-speed fine diamonds.&#xD;
&#xD;
      In control group ketac molar with coating:&#xD;
&#xD;
      -After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20&#xD;
      seconds using a photo-curing light.&#xD;
&#xD;
      In study group &quot; Ketac Universal Aplicap 3M without coating&quot;:&#xD;
&#xD;
      -The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer&#xD;
      restorative is a self-cure, one-step placement material designed to help to finish faster.&#xD;
      There's no need for conditioning, coating or light-curing steps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 3, 2019</start_date>
  <completion_date type="Anticipated">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <phase>Phase 1</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>Occlusal Caries in Posterior teeth</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Double Blinded (Participant and Outcome assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Distance penetrated by the Explorer at the tooth restoration interface</measure>
    <time_frame>during procedure</time_frame>
    <description>The explorer will be drawn across the surface of the restoration toward the tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated by the Explorer at the tooth restoration interface</measure>
    <time_frame>3 months</time_frame>
    <description>The explorer will be drawn across the surface of the restoration toward the tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated by the Explorer at the tooth restoration interface</measure>
    <time_frame>6 months</time_frame>
    <description>The explorer will be drawn across the surface of the restoration toward the tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated by the Explorer at the tooth restoration interface</measure>
    <time_frame>12 months</time_frame>
    <description>The explorer will be drawn across the surface of the restoration toward the tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of mismatch from the normal range of tooth shades and translucency</measure>
    <time_frame>during procedure</time_frame>
    <description>Visual inspection to check the proximity of the shade from the natural tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of mismatch from the normal range of tooth shades and translucency</measure>
    <time_frame>3 months</time_frame>
    <description>Visual inspection to check the proximity of the shade from the natural tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of mismatch from the normal range of tooth shades and translucency</measure>
    <time_frame>6 months</time_frame>
    <description>Visual inspection to check the proximity of the shade from the natural tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of mismatch from the normal range of tooth shades and translucency</measure>
    <time_frame>12 months</time_frame>
    <description>Visual inspection to check the proximity of the shade from the natural tooth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated along the restoration in a pulpal direction</measure>
    <time_frame>during procedure</time_frame>
    <description>Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated along the restoration in a pulpal direction</measure>
    <time_frame>3 months</time_frame>
    <description>Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated along the restoration in a pulpal direction</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated along the restoration in a pulpal direction</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins</measure>
    <time_frame>during procedure</time_frame>
    <description>Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins</measure>
    <time_frame>3 months</time_frame>
    <description>Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins</measure>
    <time_frame>6 months</time_frame>
    <description>Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins</measure>
    <time_frame>12 months</time_frame>
    <description>Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of continuous movement of an explorer across the surface of the restoration</measure>
    <time_frame>during procedure</time_frame>
    <description>Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of continuous movement of an explorer across the surface of the restoration</measure>
    <time_frame>3 months</time_frame>
    <description>Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of continuous movement of an explorer across the surface of the restoration</measure>
    <time_frame>6 months</time_frame>
    <description>Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area of continuous movement of an explorer across the surface of the restoration</measure>
    <time_frame>12 months</time_frame>
    <description>Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.</measure>
    <time_frame>during procedure</time_frame>
    <description>Visual inspection and explorer to check the shape and structure of the restoration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.</measure>
    <time_frame>3 months</time_frame>
    <description>Visual inspection and explorer to check the shape and structure of the restoration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.</measure>
    <time_frame>6 months</time_frame>
    <description>Visual inspection and explorer to check the shape and structure of the restoration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.</measure>
    <time_frame>12 months</time_frame>
    <description>Visual inspection and explorer to check the shape and structure of the restoration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to dentin hypersensitivity (evaporative stimulus)</measure>
    <time_frame>during procedure</time_frame>
    <description>Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to dentin hypersensitivity (evaporative stimulus)</measure>
    <time_frame>3 months</time_frame>
    <description>Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to dentin hypersensitivity (evaporative stimulus)</measure>
    <time_frame>6 months</time_frame>
    <description>Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to dentin hypersensitivity (evaporative stimulus)</measure>
    <time_frame>12 months</time_frame>
    <description>Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Occlusal Caries</condition>
  <arm_group>
    <arm_group_label>Non Coated Glass Ionomer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Glass Ionomer with Coat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less &quot;technique sensitive&quot; than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Non Coated Glass Ionomer</intervention_name>
    <description>KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.</description>
    <arm_group_label>Non Coated Glass Ionomer</arm_group_label>
    <other_name>Ketac Universal Aplicap- Glass Ionomer Restorative</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Conventional Glass Ionomer with Coat</intervention_name>
    <description>Conventional Glass Ionomer with Coat</description>
    <arm_group_label>Conventional Glass Ionomer with Coat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of at least 2 carious class I in same patient.&#xD;
&#xD;
          -  The absence of tooth mobility.&#xD;
&#xD;
          -  Presence of contact with opposite teeth without any abnormal occlusion stress for the&#xD;
             selected teeth.&#xD;
&#xD;
          -  Accessible isolation and observable and easily accessible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with poor oral hygiene. According to DMF or ADA criteria.&#xD;
&#xD;
          2. The presence of any para functional habit.&#xD;
&#xD;
          3. Abnormal occlusion.&#xD;
&#xD;
          4. Any regurgitation problem.&#xD;
&#xD;
          5. Subjects with compromised medical history.&#xD;
&#xD;
          6. Pulpitis, non-vital or endodontically treated teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud M Eldamanhoury, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Manial</state>
        <zip>00202</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mahmoud Magdy Eldamanhoury</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Occlusal Caries</keyword>
  <keyword>Glass Ionomer</keyword>
  <keyword>Tooth colored Restoration</keyword>
  <keyword>Non-Coated Glass Ionomer</keyword>
  <keyword>Universal Glass Ionomer</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Undecided: It is not yet known if there will be a plan to make IPD available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>expecting to have all the data during January or February 2021</ipd_time_frame>
    <ipd_access_criteria>IPD through contacting the main author Mahmoud.eldamanhory@dentistry.cu.edu.eg.com</ipd_access_criteria>
    <ipd_url>http://erepository.cu.edu.eg/index.php/cutheses</ipd_url>
  </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/NCT04463342
org study id: CairoU-MMEldamanhoury
nct id: NCT04463342
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In patients with occlusal caries in posterior teeth, does the use of recently introduced non
      coated glass ionomer provide better clinical performance compared to conventional glass
      ionomer with surface coating?

      -Primary objective: To evaluate clinical performance of different types of restorations
      (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries
      in posterior teeth.
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo
      University; The operator in charge will be Mahmoud Magdy Eldamanhory

      Patients will be selected from the outpatient clinic of the department Conservative Dentistry
      Department, Faculty of Dentistry, Cairo University

        -  Local anesthesia will be applied to patients complaining about pain or sensitivity to
           prevent discomfort during restorative procedures.

        -  Conservative cavity design will be used according to the principals of minimal invasive
           dentistry.

        -  All the cavities will be performed by the main author using #57 straight plain carbide
           fissure bur held in high speed contra-angled hand piece with water cooling system.

        -  All internal line angles will be slightly rounded.

        -  Each bur will be discarded after 5 preparations

        -  If deep caries will be found, it will be removed with large round bur at low speed and a
           thin layer of calcium hydroxide will be placed on the deep portion of the cavity.

        -  Isolation will be maintained by using Rubber Dam.

        -  The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20
           seconds (Cavity Conditioner, GC), washed, and briefly dried.

        -  The restorations will inject into the cavity.

        -  After the passage of the manufacturer's recommended setting time of 2.5 minutes, the
           restoration will be trimmed and polished wet using high-speed fine diamonds.

      In control group ketac molar with coating:

      -After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20
      seconds using a photo-curing light.

      In study group " Ketac Universal Aplicap 3M without coating":

      -The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer
      restorative is a self-cure, one-step placement material designed to help to finish faster.
      There's no need for conditioning, coating or light-curing steps.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Occlusal Caries in Posterior teeth
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double Blinded (Participant and Outcome assessor)
measure: Distance penetrated by the Explorer at the tooth restoration interface
time frame: during procedure
description: The explorer will be drawn across the surface of the restoration toward the tooth
measure: Distance penetrated by the Explorer at the tooth restoration interface
time frame: 3 months
description: The explorer will be drawn across the surface of the restoration toward the tooth
measure: Distance penetrated by the Explorer at the tooth restoration interface
time frame: 6 months
description: The explorer will be drawn across the surface of the restoration toward the tooth
measure: Distance penetrated by the Explorer at the tooth restoration interface
time frame: 12 months
description: The explorer will be drawn across the surface of the restoration toward the tooth
measure: The degree of mismatch from the normal range of tooth shades and translucency
time frame: during procedure
description: Visual inspection to check the proximity of the shade from the natural tooth
measure: The degree of mismatch from the normal range of tooth shades and translucency
time frame: 3 months
description: Visual inspection to check the proximity of the shade from the natural tooth
measure: The degree of mismatch from the normal range of tooth shades and translucency
time frame: 6 months
description: Visual inspection to check the proximity of the shade from the natural tooth
measure: The degree of mismatch from the normal range of tooth shades and translucency
time frame: 12 months
description: Visual inspection to check the proximity of the shade from the natural tooth
measure: Distance penetrated along the restoration in a pulpal direction
time frame: during procedure
description: Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
measure: Distance penetrated along the restoration in a pulpal direction
time frame: 3 months
description: Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
measure: Distance penetrated along the restoration in a pulpal direction
time frame: 6 months
description: Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
measure: Distance penetrated along the restoration in a pulpal direction
time frame: 12 months
description: Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
time frame: during procedure
description: Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
time frame: 3 months
description: Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
time frame: 6 months
description: Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
time frame: 12 months
description: Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
measure: Area of continuous movement of an explorer across the surface of the restoration
time frame: during procedure
description: Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
measure: Area of continuous movement of an explorer across the surface of the restoration
time frame: 3 months
description: Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
measure: Area of continuous movement of an explorer across the surface of the restoration
time frame: 6 months
description: Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
measure: Area of continuous movement of an explorer across the surface of the restoration
time frame: 12 months
description: Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
measure: Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
time frame: during procedure
description: Visual inspection and explorer to check the shape and structure of the restoration
measure: Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
time frame: 3 months
description: Visual inspection and explorer to check the shape and structure of the restoration
measure: Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
time frame: 6 months
description: Visual inspection and explorer to check the shape and structure of the restoration
measure: Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.
time frame: 12 months
description: Visual inspection and explorer to check the shape and structure of the restoration
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
time frame: during procedure
description: Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
time frame: 3 months
description: Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
time frame: 6 months
description: Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
time frame: 12 months
description: Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
arm group label: Non Coated Glass Ionomer
arm group type: Experimental
description: A faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers.
arm group label: Conventional Glass Ionomer with Coat
arm group type: Active Comparator
description: A bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less "technique sensitive" than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination.
intervention type: Combination Product
intervention name: Non Coated Glass Ionomer
description: KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.
arm group label: Non Coated Glass Ionomer
other name: Ketac Universal Aplicap- Glass Ionomer Restorative
intervention type: Combination Product
intervention name: Conventional Glass Ionomer with Coat
description: Conventional Glass Ionomer with Coat
arm group label: Conventional Glass Ionomer with Coat
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mahmoud M Eldamanhoury, Master
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mahmoud Magdy Eldamanhoury
investigator title: Principal investigator
mesh term: Methamphetamine
sharing ipd: Yes
ipd description: Undecided: It is not yet known if there will be a plan to make IPD available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: expecting to have all the data during January or February 2021
ipd access criteria: IPD through contacting the main author Mahmoud.eldamanhory@dentistry.cu.edu.eg.com
ipd url: http://erepository.cu.edu.eg/index.php/cutheses