<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/NCT03305679</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-FixPro-01-2017</org_study_id>
    <nct_id>NCT03305679</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of the Immediate Implant Loading</brief_title>
  <official_title>Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Joseph University, Beirut, Lebanon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Syrian Atomic Energy Agency, Damascus, Syria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Damascus 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>
      Aim: The aim of this study to Assess the healing process of the immediate implant loading&#xD;
      with two different provisional techniques (direct and indirect).&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      20 implant in the aesthetic zone either in the incisor or in the canine area and excluding&#xD;
      the lateral location and then immediate loading is achieved for the 20 implants (10 for&#xD;
      direct and 10 for indirect method) Clinical Aspect :color change , healing and bone&#xD;
      resorption Esthetic assessment and patient acceptance will be assessed using specific tools.&#xD;
&#xD;
      Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The aim of this study to Assess the healing process of the immediate implant loading&#xD;
      with two different provisional techniques (direct and indirect).&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine&#xD;
      area and excluding the lateral location and then immediate loading is achieved for the 20&#xD;
      implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing&#xD;
      and bone resorption Aesthetic assessment and patient acceptance will be assessed using&#xD;
      specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue&#xD;
      vision.&#xD;
&#xD;
      The participants were non-dental students from University colleges in and around Damascus.&#xD;
      They were recruited by reviewing the case documents 20 patient with hapless incisal and&#xD;
      canine for extraction and immediate implantation and immediate loading with either the two&#xD;
      different provisional methods participants had to demonstrate a hopeless central incisor or&#xD;
      canine with no perio-active infection. With two types of provisional technique we will have a&#xD;
      two groups were calculated a priori in such a way that index can be identified with with&#xD;
      alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of&#xD;
      94% (g power 3.1.3) based on a pilot study.&#xD;
&#xD;
      Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change&#xD;
      and aesthetic assessment by three general dentists will be achieved. Replica technique&#xD;
      required the application of impression material build up of addition-silicone.&#xD;
      Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to&#xD;
      all restorations interior, after which the crowns were set onto basic samples. Impression&#xD;
      material was polymerized within the time which is recommended by the manufacturer, while the&#xD;
      pressure force of 50 N was applied toward occlusal direction After the removal of all&#xD;
      restorations from the basic samples, the layer of impression material remained on the&#xD;
      restoration's inner surface due to its higher roughness compared to the abutment surface.&#xD;
      With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope&#xD;
      (SEM) images will give a close understanding of the surface. Easy shade will measure the&#xD;
      color change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">January 19, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in alveolar bone level</measure>
    <time_frame>T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation</time_frame>
    <description>This will be measured using cone-beam computed tomography images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Gingival Index</measure>
    <time_frame>T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation</time_frame>
    <description>This will be measured using the the gingival index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Esthetic Appearance</measure>
    <time_frame>T1: at one day before implantation, T2: at three months following implantation</time_frame>
    <description>This will be measured by using the White Esthetic Scale (WES)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Plaque Index</measure>
    <time_frame>T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation</time_frame>
    <description>This will be measured using the the plaque index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Pink Esthetic Scale</measure>
    <time_frame>T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation</time_frame>
    <description>This will be measured using the Pink Esthetic Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Restoration Color</measure>
    <time_frame>T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation</time_frame>
    <description>This will be measured using a standardized color guide</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Implant Site Reaction</condition>
  <arm_group>
    <arm_group_label>Direct provisional technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients here will be subjected to the direct provisional technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indirect Provisional technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients here will be subjected to the indirect provisional technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct provisional technique</intervention_name>
    <description>The method of implantation will be accomplished directly.</description>
    <arm_group_label>Direct provisional technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Indirect Provisional technique</intervention_name>
    <description>The method of implantation will be accomplished indirectly.</description>
    <arm_group_label>Indirect Provisional technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. esthetic request.&#xD;
&#xD;
          2. either incisor or canine indicated for extraction.&#xD;
&#xD;
          3. symmetrical gingival level.&#xD;
&#xD;
          4. no active periodontal disease.&#xD;
&#xD;
          5. age between 20-40 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lateral hopeless tooth .&#xD;
&#xD;
          2. Active periodontal lesion .&#xD;
&#xD;
          3. loss of periodontal tissue .&#xD;
&#xD;
          4. missed incisor or missed canine in the area of implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anas Abdo, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osama Yousuf Solieman, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Makary, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mirza Allaf, DDS MSc PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oral Implantology -Sante Jousef University - School of Dental Medicine</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Fixed Prosthodontics, University of Damsacus</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nano Physical lab and biomaterial Lab - College of Applied Sciences</name>
      <address>
        <city>Damascus</city>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34.</citation>
    <PMID>27314117</PMID>
  </reference>
  <reference>
    <citation>Sanchez-Siles M, Munoz-Camara D, Salazar-Sanchez N, Camacho-Alonso F, Calvo-Guirado JL. Crestal bone loss around submerged and non-submerged implants during the osseointegration phase with different healing abutment designs: a randomized prospective clinical study. Clin Oral Implants Res. 2018 Jul;29(7):808-812. doi: 10.1111/clr.12981. Epub 2016 Sep 5.</citation>
    <PMID>27596682</PMID>
  </reference>
  <reference>
    <citation>Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.</citation>
    <PMID>27501953</PMID>
  </reference>
  <reference>
    <citation>Sethi A, Kaus T. Immediate Replacement of Single Teeth With Immediately Loaded Implants: Retrospective Analysis of a Clinical Case Series. Implant Dent. 2017 Feb;26(1):30-36. doi: 10.1097/ID.0000000000000512.</citation>
    <PMID>27902498</PMID>
  </reference>
  <reference>
    <citation>Zhang S, Wang S, Song Y. Immediate loading for implant restoration compared with early or conventional loading: A meta-analysis. J Craniomaxillofac Surg. 2017 Jun;45(6):793-803. doi: 10.1016/j.jcms.2016.05.002. Epub 2016 May 14.</citation>
    <PMID>28351528</PMID>
  </reference>
  <reference>
    <citation>Abdel-Azim T, Rogers K, Elathamna E, Zandinejad A, Metz M, Morton D. Comparison of the marginal fit of lithium disilicate crowns fabricated with CAD/CAM technology by using conventional impressions and two intraoral digital scanners. J Prosthet Dent. 2015 Oct;114(4):554-9. doi: 10.1016/j.prosdent.2015.04.001. Epub 2015 Jun 20.</citation>
    <PMID>26100929</PMID>
  </reference>
  <reference>
    <citation>Varol S, Kulak-Ozkan Y. In Vitro Comparison of Marginal and Internal Fit of Press-on-Metal Ceramic (PoM) Restorations with Zirconium-Supported and Conventional Metal Ceramic Fixed Partial Dentures Before and After Veneering. J Prosthodont. 2015 Jul;24(5):387-93. doi: 10.1111/jopr.12229. Epub 2014 Oct 1.</citation>
    <PMID>25274041</PMID>
  </reference>
  <reference>
    <citation>Renne W, Wolf B, Kessler R, McPherson K, Mennito AS. Evaluation of the Marginal Fit of CAD/CAM Crowns Fabricated Using Two Different Chairside CAD/CAM Systems on Preparations of Varying Quality. J Esthet Restor Dent. 2015 Jul-Aug;27(4):194-202. doi: 10.1111/jerd.12148. Epub 2015 Jul 14.</citation>
    <PMID>26177118</PMID>
  </reference>
  <reference>
    <citation>Louropoulou A, Slot DE, Van der Weijden F. Influence of mechanical instruments on the biocompatibility of titanium dental implants surfaces: a systematic review. Clin Oral Implants Res. 2015 Jul;26(7):841-50. doi: 10.1111/clr.12365. Epub 2014 Mar 19.</citation>
    <PMID>24641774</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03305679
org study id: UDDS-FixPro-01-2017
nct id: NCT03305679
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim: The aim of this study to Assess the healing process of the immediate implant loading
      with two different provisional techniques (direct and indirect).

      Materials and methods:

      20 implant in the aesthetic zone either in the incisor or in the canine area and excluding
      the lateral location and then immediate loading is achieved for the 20 implants (10 for
      direct and 10 for indirect method) Clinical Aspect :color change , healing and bone
      resorption Esthetic assessment and patient acceptance will be assessed using specific tools.

      Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
Aim: The aim of this study to Assess the healing process of the immediate implant loading
      with two different provisional techniques (direct and indirect).

      Materials and methods:

      20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine
      area and excluding the lateral location and then immediate loading is achieved for the 20
      implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing
      and bone resorption Aesthetic assessment and patient acceptance will be assessed using
      specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue
      vision.

      The participants were non-dental students from University colleges in and around Damascus.
      They were recruited by reviewing the case documents 20 patient with hapless incisal and
      canine for extraction and immediate implantation and immediate loading with either the two
      different provisional methods participants had to demonstrate a hopeless central incisor or
      canine with no perio-active infection. With two types of provisional technique we will have a
      two groups were calculated a priori in such a way that index can be identified with with
      alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of
      94% (g power 3.1.3) based on a pilot study.

      Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change
      and aesthetic assessment by three general dentists will be achieved. Replica technique
      required the application of impression material build up of addition-silicone.
      Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to
      all restorations interior, after which the crowns were set onto basic samples. Impression
      material was polymerized within the time which is recommended by the manufacturer, while the
      pressure force of 50 N was applied toward occlusal direction After the removal of all
      restorations from the basic samples, the layer of impression material remained on the
      restoration's inner surface due to its higher roughness compared to the abutment surface.
      With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope
      (SEM) images will give a close understanding of the surface. Easy shade will measure the
      color change.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in alveolar bone level
time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
description: This will be measured using cone-beam computed tomography images
measure: Change in the Gingival Index
time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
description: This will be measured using the the gingival index
measure: Change in Esthetic Appearance
time frame: T1: at one day before implantation, T2: at three months following implantation
description: This will be measured by using the White Esthetic Scale (WES)
measure: Change in the Plaque Index
time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
description: This will be measured using the the plaque index
measure: Change in the Pink Esthetic Scale
time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
description: This will be measured using the Pink Esthetic Scale
measure: Change in Restoration Color
time frame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
description: This will be measured using a standardized color guide
arm group label: Direct provisional technique
arm group type: Experimental
description: Patients here will be subjected to the direct provisional technique
arm group label: Indirect Provisional technique
arm group type: Active Comparator
description: Patients here will be subjected to the indirect provisional technique
intervention type: Procedure
intervention name: Direct provisional technique
description: The method of implantation will be accomplished directly.
arm group label: Direct provisional technique
intervention type: Procedure
intervention name: Indirect Provisional technique
description: The method of implantation will be accomplished indirectly.
arm group label: Indirect Provisional technique
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anas Abdo, DDS MSc
role: Principal Investigator
affiliation: PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School
last name: Osama Yousuf Solieman, DDS MSc PhD
role: Study Director
affiliation: Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France
last name: Christian Makary, DDS MSc PhD
role: Study Director
affiliation: Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon
last name: Mirza Allaf, DDS MSc PhD
role: Study Chair
affiliation: Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
facility: 
facility: 
facility: 
country: Lebanon
country: Syrian Arab Republic
citation: Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34.
PMID: 27314117
citation: Sanchez-Siles M, Munoz-Camara D, Salazar-Sanchez N, Camacho-Alonso F, Calvo-Guirado JL. Crestal bone loss around submerged and non-submerged implants during the osseointegration phase with different healing abutment designs: a randomized prospective clinical study. Clin Oral Implants Res. 2018 Jul;29(7):808-812. doi: 10.1111/clr.12981. Epub 2016 Sep 5.
PMID: 27596682
citation: Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
PMID: 27501953
citation: Sethi A, Kaus T. Immediate Replacement of Single Teeth With Immediately Loaded Implants: Retrospective Analysis of a Clinical Case Series. Implant Dent. 2017 Feb;26(1):30-36. doi: 10.1097/ID.0000000000000512.
PMID: 27902498
citation: Zhang S, Wang S, Song Y. Immediate loading for implant restoration compared with early or conventional loading: A meta-analysis. J Craniomaxillofac Surg. 2017 Jun;45(6):793-803. doi: 10.1016/j.jcms.2016.05.002. Epub 2016 May 14.
PMID: 28351528
citation: Abdel-Azim T, Rogers K, Elathamna E, Zandinejad A, Metz M, Morton D. Comparison of the marginal fit of lithium disilicate crowns fabricated with CAD/CAM technology by using conventional impressions and two intraoral digital scanners. J Prosthet Dent. 2015 Oct;114(4):554-9. doi: 10.1016/j.prosdent.2015.04.001. Epub 2015 Jun 20.
PMID: 26100929
citation: Varol S, Kulak-Ozkan Y. In Vitro Comparison of Marginal and Internal Fit of Press-on-Metal Ceramic (PoM) Restorations with Zirconium-Supported and Conventional Metal Ceramic Fixed Partial Dentures Before and After Veneering. J Prosthodont. 2015 Jul;24(5):387-93. doi: 10.1111/jopr.12229. Epub 2014 Oct 1.
PMID: 25274041
citation: Renne W, Wolf B, Kessler R, McPherson K, Mennito AS. Evaluation of the Marginal Fit of CAD/CAM Crowns Fabricated Using Two Different Chairside CAD/CAM Systems on Preparations of Varying Quality. J Esthet Restor Dent. 2015 Jul-Aug;27(4):194-202. doi: 10.1111/jerd.12148. Epub 2015 Jul 14.
PMID: 26177118
citation: Louropoulou A, Slot DE, Van der Weijden F. Influence of mechanical instruments on the biocompatibility of titanium dental implants surfaces: a systematic review. Clin Oral Implants Res. 2015 Jul;26(7):841-50. doi: 10.1111/clr.12365. Epub 2014 Mar 19.
PMID: 24641774
responsible party type: Sponsor
sharing ipd: No