<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/NCT03287934</url>
  </required_header>
  <id_info>
    <org_study_id>R.prosthodontic department</org_study_id>
    <nct_id>NCT03287934</nct_id>
  </id_info>
  <brief_title>Accuracy of Selective Laser Sinteredcomputer Guided Stents Versus Digital Light Processing Stents</brief_title>
  <acronym>RCT</acronym>
  <official_title>Accuracy of Selective Laser Sintered Computer Guided Stents Versus Digital Light Processing Stents in Immediate Implant Placement in Esthetic Zone, a Randomized Controlled Study</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>
      patient with non-restorable tooth in the esthetic zone will be recruited in the study. a&#xD;
      traumatic is done and implant will be placed using either digital light processed guides for&#xD;
      control group or selective laser sintering group for intervention group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the principle investigator will randomize and equally distribute the Eligible patients&#xD;
      between the selective laser sintering group (intervention group) and digital light processing&#xD;
      group (control group).&#xD;
&#xD;
        -  Diagnostic phase : for initial diagnosis, principle investigator will make primary&#xD;
           impression , bite registration, face bow record and periapical x-ray for each eligible&#xD;
           patients. The tooth to be extracted will be removed from the cast and replaced with an&#xD;
           artificial tooth. For construction of radio graphic stent, a clear thermoplastic sheet&#xD;
           will be pressed on the modified cast using a vacuum forming machine . A hole is done in&#xD;
           the center of the artificial tooth packed with heated gutta percha (radiopaque material)&#xD;
           for easy visualization on the cone beam during virtual implant placing. A dual scan&#xD;
           protocol with cone beam CT will be made. The first scan is for the patient wearing the&#xD;
           scan appliance while the second will be for the cast with the scan appliance.&#xD;
&#xD;
        -  Planning phase : placing of the virtual implant and designing of the surgical stent will&#xD;
           be done by virtual planning software .&#xD;
&#xD;
        -  Construction of the surgical guide: principle investigator will send the Standard&#xD;
           Language transformation (STL) file of the designed guide to a rapid prototyping center.&#xD;
           Selective laser sintering and digital light procesing will be used for intervention and&#xD;
           control group respectively. principle investigator will check for adaption of the guide&#xD;
           on the cast and cement the metallic sleeve to prevent rotation during surgery.&#xD;
&#xD;
        -  Surgical phase : principle investigator will prescribe a prophylactic antibiotic to the&#xD;
           patient three days prior the surgery. Atraumatic extraction will be carried by&#xD;
           periotomes and lancet. The integrity of the socket will be examined well by probe. The&#xD;
           guide is stabilized in its place then drilling and implant placement will be done.&#xD;
           Healing abutment is screwed in place to allow proper healing of the soft tissue. Patient&#xD;
           will be instructed to avoid hard foods and follow restrict oral hygiene measures.&#xD;
           Patient will be recalled after one week for postoperative inspection and assessment. A&#xD;
           cone beam CT will be taken for deviation assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">February 11, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Single (Participant)</masking>
    <masking_description>due to the nature of study only the participants could be blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of accuracy of implant placement clinical observation</measure>
    <time_frame>1 week</time_frame>
    <description>measuring both angular and linear deviation of implants by virtual ruler in terms of mm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Immediate Dental Implants</condition>
  <arm_group>
    <arm_group_label>digital light processing stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>according to the allocation, the experimental group will receive a digital light processing stent for immediate implant drilling and placement after atraumatic extraction of the target tooth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>selective laser sintering</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>according to the allocation, the intervention for the control group will be a selective laser sintering stent after atraumatic extraction of the target tooth for immediately implant placement. the selective laser sintering stent will be adapted and drilling will be done through the stent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>selective laser sintered stent</intervention_name>
    <description>after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with selective laser sintering technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.</description>
    <arm_group_label>digital light processing stent</arm_group_label>
    <arm_group_label>selective laser sintering</arm_group_label>
    <other_name>Mega selective laser sintering (brand name )</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>digital light processing(dlp)</intervention_name>
    <description>after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with digital light processing technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.</description>
    <arm_group_label>digital light processing stent</arm_group_label>
    <arm_group_label>selective laser sintering</arm_group_label>
    <other_name>mogassam (brand name)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age should be more than 18 years old&#xD;
&#xD;
          2. Hopeless tooth in esthetic zone due to caries, endodontical problem or trauma with&#xD;
             both neighboring teeth present.&#xD;
&#xD;
          3. Good oral hygiene&#xD;
&#xD;
          4. No periapical lesions (acute accesses or chronic fistula)&#xD;
&#xD;
          5. Adequate bone (5 mm) below the tooth to allow primary implant stability&#xD;
&#xD;
          6. Sufficient Medio-distal bone about 1.5 from each side&#xD;
&#xD;
          7. sufficient labial bone&#xD;
&#xD;
          8. sufficient band of keratinized mucosa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. heavy smoking&#xD;
&#xD;
          2. any systemic condition that is considered absolute contraindication for implant&#xD;
             placement&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. in adequate inter-arch space&#xD;
&#xD;
          5. parafunctional habits as bruxism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Manil</state>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Abduo, J., Lyons, K. &amp; Bennamoun, M., 2014. Trends in Computer-Aided Manufacturing in Prosthodontics: A Review of the Available Streams. International Journal of Dentistry, 2014, pp.1-15. Available at: http://www.hindawi.com/journals/ijd/2014/783948/. Alzoubi, Fawaz, Nima Massoomi, and A.N., 2016. Accuracy Assessment of Immediate and Delayed Implant Placements Using CAD/CAM Surgical Guides. Journal of Oral Implantology ., 42(5), pp.391-398. Arısan, V. et al., 2013. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. The International Journal of Oral &amp; Maxillofacial Implants, 28(1), pp.190-204. Available at: http://www.quintpub.com/journals/find_article.php?doi=10.11607/jomi.2691.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>mahetab hamdi</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>selective laser sintering, digital light processing stents</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03287934
org study id: R.prosthodontic department
nct id: NCT03287934
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
patient with non-restorable tooth in the esthetic zone will be recruited in the study. a
      traumatic is done and implant will be placed using either digital light processed guides for
      control group or selective laser sintering group for intervention group.
the principle investigator will randomize and equally distribute the Eligible patients
      between the selective laser sintering group (intervention group) and digital light processing
      group (control group).

        -  Diagnostic phase : for initial diagnosis, principle investigator will make primary
           impression , bite registration, face bow record and periapical x-ray for each eligible
           patients. The tooth to be extracted will be removed from the cast and replaced with an
           artificial tooth. For construction of radio graphic stent, a clear thermoplastic sheet
           will be pressed on the modified cast using a vacuum forming machine . A hole is done in
           the center of the artificial tooth packed with heated gutta percha (radiopaque material)
           for easy visualization on the cone beam during virtual implant placing. A dual scan
           protocol with cone beam CT will be made. The first scan is for the patient wearing the
           scan appliance while the second will be for the cast with the scan appliance.

        -  Planning phase : placing of the virtual implant and designing of the surgical stent will
           be done by virtual planning software .

        -  Construction of the surgical guide: principle investigator will send the Standard
           Language transformation (STL) file of the designed guide to a rapid prototyping center.
           Selective laser sintering and digital light procesing will be used for intervention and
           control group respectively. principle investigator will check for adaption of the guide
           on the cast and cement the metallic sleeve to prevent rotation during surgery.

        -  Surgical phase : principle investigator will prescribe a prophylactic antibiotic to the
           patient three days prior the surgery. Atraumatic extraction will be carried by
           periotomes and lancet. The integrity of the socket will be examined well by probe. The
           guide is stabilized in its place then drilling and implant placement will be done.
           Healing abutment is screwed in place to allow proper healing of the soft tissue. Patient
           will be instructed to avoid hard foods and follow restrict oral hygiene measures.
           Patient will be recalled after one week for postoperative inspection and assessment. A
           cone beam CT will be taken for deviation assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: due to the nature of study only the participants could be blinded
measure: evaluation of accuracy of implant placement clinical observation
time frame: 1 week
description: measuring both angular and linear deviation of implants by virtual ruler in terms of mm
arm group label: digital light processing stent
arm group type: Experimental
description: according to the allocation, the experimental group will receive a digital light processing stent for immediate implant drilling and placement after atraumatic extraction of the target tooth.
arm group label: selective laser sintering
arm group type: Active Comparator
description: according to the allocation, the intervention for the control group will be a selective laser sintering stent after atraumatic extraction of the target tooth for immediately implant placement. the selective laser sintering stent will be adapted and drilling will be done through the stent.
intervention type: Device
intervention name: selective laser sintered stent
description: after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with selective laser sintering technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
arm group label: digital light processing stent
arm group label: selective laser sintering
other name: Mega selective laser sintering (brand name )
intervention type: Device
intervention name: digital light processing(dlp)
description: after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with digital light processing technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
arm group label: digital light processing stent
arm group label: selective laser sintering
other name: mogassam (brand name)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Abduo, J., Lyons, K. & Bennamoun, M., 2014. Trends in Computer-Aided Manufacturing in Prosthodontics: A Review of the Available Streams. International Journal of Dentistry, 2014, pp.1-15. Available at: http://www.hindawi.com/journals/ijd/2014/783948/. Alzoubi, Fawaz, Nima Massoomi, and A.N., 2016. Accuracy Assessment of Immediate and Delayed Implant Placements Using CAD/CAM Surgical Guides. Journal of Oral Implantology ., 42(5), pp.391-398. Arısan, V. et al., 2013. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. The International Journal of Oral & Maxillofacial Implants, 28(1), pp.190-204. Available at: http://www.quintpub.com/journals/find_article.php?doi=10.11607/jomi.2691.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: mahetab hamdi
investigator title: principal investigator
sharing ipd: No