<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/NCT03281603</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-08-24</org_study_id>
    <nct_id>NCT03281603</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction &amp; Retention of Milled, 3D Printed and Conventional Complete Dentures</brief_title>
  <official_title>A Study Comparing Patient Satisfaction and Retention of CAD /CAM Milled Complete Dentures and 3D Printed CAD/CAM Complete Dentures Versus Conventional Complete Dentures: 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>
      The objective of this trial is to compare patient satisfaction and retention of complete&#xD;
      denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and&#xD;
      conventional technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient examination and diagnosis will be made at the outpatient clinic, department of&#xD;
      prosthodontics, faculty of Dentistry-Cairo University. Eligible Patients following the&#xD;
      inclusion criteria will be consented to enrol in the trial. Randomization and allocation&#xD;
      concealment will be done through sealed envelopes having groups for interventions and&#xD;
      comparator. Each patient enrolled in the trial will pick an envelope having either the&#xD;
      intervention or control group.&#xD;
&#xD;
      Preliminary impressions will be made and poured to study casts. Customizing trays from&#xD;
      autopolymerising acrylic resins for final impressions with Zinc Oxide Eugenol , then&#xD;
      impressions will be poured into dental stone producing master casts. Record bite blocks will&#xD;
      then be constructed and bite registration will be made.&#xD;
&#xD;
      All bite records with their corresponding master casts will be digitalized by an extraoral&#xD;
      desktop 3D scanner having the station sequence of scanning upper cast, lower cast then bite&#xD;
      registration to be stored as standard triangulation language (STL) files.&#xD;
&#xD;
      STL files are then imported to EXOCAD design software designing full dentures with their&#xD;
      permanent bases, teeth sizes and shapes following the recorded inter-arch space. Full upper&#xD;
      and lower designed denture bases will be stored as STL files ready for manufacturing.&#xD;
&#xD;
      In first Intervention: STL files will be imported to SHERA CNC CAM software ready for nesting&#xD;
      each file for the suitable PMMA block size and height, ready for milling them in denture&#xD;
      bases with SHERA 5-axis Eco-mill milling machine . After milling denture bases, acrylic teeth&#xD;
      will be chosen for each patient with the suitable shade and size following the inter-arch&#xD;
      space, then glued by auto-polymerizing resin in their corresponding sockets in the milled&#xD;
      denture bases.&#xD;
&#xD;
      In second intervention: STL files will be imported to Mogassam 3D-printer CAM software&#xD;
      followed by adjusting the object to be virtually placed on X,Y and Z axes on the printer&#xD;
      plate to be ready for layering it in three dimension. Photopolymerizable PMMA liquid resin&#xD;
      will be added in the printer and the files processed into 3D printed upper and lower denture&#xD;
      bases. Acrylic teeth are then glued in their sockets in the printed denture bases using&#xD;
      auto-polymerizable resin.&#xD;
&#xD;
      In control group:Conventional complete denture construction by normal processing steps will&#xD;
      be made for patients enrolled in the control group.&#xD;
&#xD;
      For the three groups, full dentures will be delivered and checked for occlusion, speech and&#xD;
      mastication. Patient satisfaction will be assessed by a questionnaire template for each&#xD;
      patient to be recorded at the day of delivery (baseline), 3months then 6 months. Retention&#xD;
      for dentures will be assessed by engaging the snap hook on denture bases and pulling action&#xD;
      will be made with the digital force gauge device to obtain the records on the day of delivery&#xD;
      (baseline), 3months then 6 months' follow-up interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 1, 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>The Principal investigator, main supervisors and co-supervisor cannot be blinded as the trial will include digital designing of complete dentures on the CAD software and in the steps of the manufacturing techniques.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>The questionnaire will include 5 main categories; each category having questions about Functional complaint about the denture, Overall mastication ability, Masticating ability for different types of food, Effect of mental and daily life and Overall denture satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>6 months</time_frame>
    <description>Digital Force gauge device applying a pulling action on a snap hook attached to geometric center of denture bases</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Complete Denture</condition>
  <arm_group>
    <arm_group_label>CAD/CAM complete denture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First intervention: Constructing complete denture by CAD/CAM technology utilizing milling technique.&#xD;
Second intervention:Constructing complete denture CAD/CAM technology utilizing 3D printing technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional complete denture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Constructing complete denture by conventional technique of denture processing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CAD/CAM complete denture</intervention_name>
    <description>complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques</description>
    <arm_group_label>CAD/CAM complete denture</arm_group_label>
    <arm_group_label>Conventional complete denture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completely edentulous patients ranging from age 55 to 75 years.&#xD;
&#xD;
          -  Angle's Class I skeletal relationship.&#xD;
&#xD;
          -  Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.&#xD;
&#xD;
          -  Last extraction took place six months ago.&#xD;
&#xD;
          -  Normal facial symmetry.&#xD;
&#xD;
          -  Cooperative patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -Temporomandibular disorders&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Bleeding disorders or anticoagulant therapy&#xD;
&#xD;
          -  Flabby tissues or sharp mandibular residual ridge.&#xD;
&#xD;
          -  Heavy smokers.&#xD;
&#xD;
          -  Patient's with neuromuscular disorders&#xD;
&#xD;
          -  Patients on chemotherapy or radiotherapy&#xD;
&#xD;
          -  Severe psychiatric disorders&#xD;
&#xD;
          -  Angle's class II and III skeletal relationship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed M. Abo Heikal, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant lecturer, faculty of Dentistry, MSA University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry,Cairo university</name>
      <address>
        <city>Giza</city>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2.</citation>
    <PMID>23763779</PMID>
  </reference>
  <reference>
    <citation>Kanazawa M, Inokoshi M, Minakuchi S, Ohbayashi N. Trial of a CAD/CAM system for fabricating complete dentures. Dent Mater J. 2011;30(1):93-6. doi: 10.4012/dmj.2010-112. Epub 2011 Jan 26.</citation>
    <PMID>21282882</PMID>
  </reference>
  <reference>
    <citation>Maeda Y, Minoura M, Tsutsumi S, Okada M, Nokubi T. A CAD/CAM system for removable denture. Part I: Fabrication of complete dentures. Int J Prosthodont. 1994 Jan-Feb;7(1):17-21.</citation>
    <PMID>8179777</PMID>
  </reference>
  <reference>
    <citation>Han W, Li Y, Zhang Y, Lv Y, Zhang Y, Hu P, Liu H, Ma Z, Shen Y. Design and fabrication of complete dentures using CAD/CAM technology. Medicine (Baltimore). 2017 Jan;96(1):e5435. doi: 10.1097/MD.0000000000005435. Erratum In: Medicine (Baltimore). 2017 Jan 20;96(3):e6030.</citation>
    <PMID>28072686</PMID>
  </reference>
  <reference>
    <citation>Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23.</citation>
    <PMID>24461946</PMID>
  </reference>
  <reference>
    <citation>Chen H, Wang H, Lv P, Wang Y, Sun Y. Quantitative Evaluation of Tissue Surface Adaption of CAD-Designed and 3D Printed Wax Pattern of Maxillary Complete Denture. Biomed Res Int. 2015;2015:453968. doi: 10.1155/2015/453968. Epub 2015 Oct 25.</citation>
    <PMID>26583108</PMID>
  </reference>
  <reference>
    <citation>Inokoshi M, Kanazawa M, Minakuchi S. Evaluation of a complete denture trial method applying rapid prototyping. Dent Mater J. 2012 Feb 3;31(1):40-6. doi: 10.4012/dmj.2011-113. Epub 2012 Jan 21.</citation>
    <PMID>22277604</PMID>
  </reference>
  <reference>
    <citation>Torabi K, Farjood E, Hamedani S. Rapid Prototyping Technologies and their Applications in Prosthodontics, a Review of Literature. J Dent (Shiraz). 2015 Mar;16(1):1-9.</citation>
    <PMID>25759851</PMID>
  </reference>
  <reference>
    <citation>AlHelal A, AlRumaih HS, Kattadiyil MT, Baba NZ, Goodacre CJ. Comparison of retention between maxillary milled and conventional denture bases: A clinical study. J Prosthet Dent. 2017 Feb;117(2):233-238. doi: 10.1016/j.prosdent.2016.08.007. Epub 2016 Oct 17.</citation>
    <PMID>27765399</PMID>
  </reference>
  <reference>
    <citation>Bilhan H, Erdogan O, Ergin S, Celik M, Ates G, Geckili O. Complication rates and patient satisfaction with removable dentures. J Adv Prosthodont. 2012 May;4(2):109-15. doi: 10.4047/jap.2012.4.2.109. Epub 2012 May 30.</citation>
    <PMID>22737317</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Mohamed Abo Heikal</investigator_full_name>
    <investigator_title>Assistant lecturer, Department of Prosthodontics, Faculty of Dentistry, MSA University</investigator_title>
  </responsible_party>
  <keyword>Patient satisfaction</keyword>
  <keyword>Retention</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/NCT03281603
org study id: CEBD-CU-2017-08-24
nct id: NCT03281603
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this trial is to compare patient satisfaction and retention of complete
      denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and
      conventional technique.
Patient examination and diagnosis will be made at the outpatient clinic, department of
      prosthodontics, faculty of Dentistry-Cairo University. Eligible Patients following the
      inclusion criteria will be consented to enrol in the trial. Randomization and allocation
      concealment will be done through sealed envelopes having groups for interventions and
      comparator. Each patient enrolled in the trial will pick an envelope having either the
      intervention or control group.

      Preliminary impressions will be made and poured to study casts. Customizing trays from
      autopolymerising acrylic resins for final impressions with Zinc Oxide Eugenol , then
      impressions will be poured into dental stone producing master casts. Record bite blocks will
      then be constructed and bite registration will be made.

      All bite records with their corresponding master casts will be digitalized by an extraoral
      desktop 3D scanner having the station sequence of scanning upper cast, lower cast then bite
      registration to be stored as standard triangulation language (STL) files.

      STL files are then imported to EXOCAD design software designing full dentures with their
      permanent bases, teeth sizes and shapes following the recorded inter-arch space. Full upper
      and lower designed denture bases will be stored as STL files ready for manufacturing.

      In first Intervention: STL files will be imported to SHERA CNC CAM software ready for nesting
      each file for the suitable PMMA block size and height, ready for milling them in denture
      bases with SHERA 5-axis Eco-mill milling machine . After milling denture bases, acrylic teeth
      will be chosen for each patient with the suitable shade and size following the inter-arch
      space, then glued by auto-polymerizing resin in their corresponding sockets in the milled
      denture bases.

      In second intervention: STL files will be imported to Mogassam 3D-printer CAM software
      followed by adjusting the object to be virtually placed on X,Y and Z axes on the printer
      plate to be ready for layering it in three dimension. Photopolymerizable PMMA liquid resin
      will be added in the printer and the files processed into 3D printed upper and lower denture
      bases. Acrylic teeth are then glued in their sockets in the printed denture bases using
      auto-polymerizable resin.

      In control group:Conventional complete denture construction by normal processing steps will
      be made for patients enrolled in the control group.

      For the three groups, full dentures will be delivered and checked for occlusion, speech and
      mastication. Patient satisfaction will be assessed by a questionnaire template for each
      patient to be recorded at the day of delivery (baseline), 3months then 6 months. Retention
      for dentures will be assessed by engaging the snap hook on denture bases and pulling action
      will be made with the digital force gauge device to obtain the records on the day of delivery
      (baseline), 3months then 6 months' follow-up interval.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: The Principal investigator, main supervisors and co-supervisor cannot be blinded as the trial will include digital designing of complete dentures on the CAD software and in the steps of the manufacturing techniques.
measure: patient satisfaction
time frame: 6 months
description: The questionnaire will include 5 main categories; each category having questions about Functional complaint about the denture, Overall mastication ability, Masticating ability for different types of food, Effect of mental and daily life and Overall denture satisfaction.
measure: Retention
time frame: 6 months
description: Digital Force gauge device applying a pulling action on a snap hook attached to geometric center of denture bases
arm group label: CAD/CAM complete denture
arm group type: Experimental
description: First intervention: Constructing complete denture by CAD/CAM technology utilizing milling technique.
Second intervention:Constructing complete denture CAD/CAM technology utilizing 3D printing technique
arm group label: Conventional complete denture
arm group type: Active Comparator
description: Constructing complete denture by conventional technique of denture processing
intervention type: Device
intervention name: CAD/CAM complete denture
description: complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
arm group label: CAD/CAM complete denture
arm group label: Conventional complete denture
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed M. Abo Heikal, PHD
role: Principal Investigator
affiliation: Assistant lecturer, faculty of Dentistry, MSA University
facility: 
facility: 
country: Egypt
citation: Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2.
PMID: 23763779
citation: Kanazawa M, Inokoshi M, Minakuchi S, Ohbayashi N. Trial of a CAD/CAM system for fabricating complete dentures. Dent Mater J. 2011;30(1):93-6. doi: 10.4012/dmj.2010-112. Epub 2011 Jan 26.
PMID: 21282882
citation: Maeda Y, Minoura M, Tsutsumi S, Okada M, Nokubi T. A CAD/CAM system for removable denture. Part I: Fabrication of complete dentures. Int J Prosthodont. 1994 Jan-Feb;7(1):17-21.
PMID: 8179777
citation: Han W, Li Y, Zhang Y, Lv Y, Zhang Y, Hu P, Liu H, Ma Z, Shen Y. Design and fabrication of complete dentures using CAD/CAM technology. Medicine (Baltimore). 2017 Jan;96(1):e5435. doi: 10.1097/MD.0000000000005435. Erratum In: Medicine (Baltimore). 2017 Jan 20;96(3):e6030.
PMID: 28072686
citation: Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23.
PMID: 24461946
citation: Chen H, Wang H, Lv P, Wang Y, Sun Y. Quantitative Evaluation of Tissue Surface Adaption of CAD-Designed and 3D Printed Wax Pattern of Maxillary Complete Denture. Biomed Res Int. 2015;2015:453968. doi: 10.1155/2015/453968. Epub 2015 Oct 25.
PMID: 26583108
citation: Inokoshi M, Kanazawa M, Minakuchi S. Evaluation of a complete denture trial method applying rapid prototyping. Dent Mater J. 2012 Feb 3;31(1):40-6. doi: 10.4012/dmj.2011-113. Epub 2012 Jan 21.
PMID: 22277604
citation: Torabi K, Farjood E, Hamedani S. Rapid Prototyping Technologies and their Applications in Prosthodontics, a Review of Literature. J Dent (Shiraz). 2015 Mar;16(1):1-9.
PMID: 25759851
citation: AlHelal A, AlRumaih HS, Kattadiyil MT, Baba NZ, Goodacre CJ. Comparison of retention between maxillary milled and conventional denture bases: A clinical study. J Prosthet Dent. 2017 Feb;117(2):233-238. doi: 10.1016/j.prosdent.2016.08.007. Epub 2016 Oct 17.
PMID: 27765399
citation: Bilhan H, Erdogan O, Ergin S, Celik M, Ates G, Geckili O. Complication rates and patient satisfaction with removable dentures. J Adv Prosthodont. 2012 May;4(2):109-15. doi: 10.4047/jap.2012.4.2.109. Epub 2012 May 30.
PMID: 22737317
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Mohamed Abo Heikal
investigator title: Assistant lecturer, Department of Prosthodontics, Faculty of Dentistry, MSA University
sharing ipd: No