<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/NCT03230500</url>
  </required_header>
  <id_info>
    <org_study_id>Faculty of Dentistry</org_study_id>
    <nct_id>NCT03230500</nct_id>
  </id_info>
  <brief_title>Computer Guided Versus Free Hand Immediate Implant Placement</brief_title>
  <official_title>Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, 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>
      Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone&#xD;
      will be recruited to the study. After extraction of the tooth implant will be placed&#xD;
      immediately, implants will be placed either by free hand or computer guided technique.&#xD;
      patient satisfaction will be evaluated as primary outcome and early implant failure was&#xD;
      evaluated as secondary outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General operative procedures:&#xD;
&#xD;
      Eligible patients will be randomized, at the surgical phase in two groups, study group (in&#xD;
      which computer guided implant placement was done using computer aided surgical guide) and&#xD;
      comparative group (in which free hand implant placement was done).&#xD;
&#xD;
      Patients of both groups will be subjected to:&#xD;
&#xD;
      Careful clinical examination and medical and dental history taking. CBCT scan will be&#xD;
      performed while patients biting on cotton roll to separate the teeth of interest from&#xD;
      opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip&#xD;
      and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular&#xD;
      alginate impression will be made for eligible patients.For temporary crown fabrication after&#xD;
      the surgery, the tooth or root to be extracted will be modified on the study cast and an&#xD;
      artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the&#xD;
      study cast. For the test group (computer guided group), three dimensional (3d) virtual&#xD;
      planning of the surgical guide and implant position will be made with the aid of Blue Sky ®&#xD;
      implant planning software . After proper selection of implant size, diameter and position,&#xD;
      the virtual surgical guide will be exported as a STL file for 3D printing. Before the&#xD;
      surgery, adaptation of the surgical guide will be checked on the study cast and a metallic&#xD;
      sleeve will be attached at proposed implant position using adhesive.&#xD;
&#xD;
      Intraoperative procedure:&#xD;
&#xD;
      3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day&#xD;
      of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining&#xD;
      root or tooth will be performed. For a traumatic extraction, gentle application of a&#xD;
      periotome mesio-distally along with slight rotational movement. After extraction, intact&#xD;
      labial and palatal socket walls will be checked using periodontal probe for immediate implant&#xD;
      placement. For the test group, the computer aided surgical guide will be checked for&#xD;
      adaptability and any interference will be removed. After that implant drilling and placement&#xD;
      will be performed using the surgical guide. For the control group, free hand implant drilling&#xD;
      and placement will be performed guided by the extraction socket walls. For both groups&#xD;
      implant primary stability will be checked by application of 35 Ncm2 force using torque wrench&#xD;
      After that, the final abutment will be screwed in its position and the temporary crown will&#xD;
      be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will&#xD;
      be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be&#xD;
      checked for any functional contact in maximum intercuspation and lateral movement. Any&#xD;
      contact with the opposing should be removed and the patient will be instructed to avoid&#xD;
      eating or incising on the temporary crown for at least two weeks. Seven days later patients&#xD;
      will be recalled for inspection and taking postoperative photos, six months thereafter, the&#xD;
      patient will receive a definitive crown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>
    <intervention_model_description>Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Due to the nature of the trial only the outcome assessor will be masked from the intervention or control group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>0-6 months</time_frame>
    <description>Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early implant failure</measure>
    <time_frame>0-6 months</time_frame>
    <description>Early implant failure will be clinically diagnosed by implant loss from mouth which will be detected by visual inspection. Early implant failure will be assessed in the interval between implant placement until functional loading (0-6 months).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Dental Implants</condition>
  <arm_group>
    <arm_group_label>Computer guided immediate implant placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the test group, the computer aided surgical guide will be used for implant drilling and placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Free hand immediate implant placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computer guided implant placement</intervention_name>
    <description>Implant will be placed immediately using computer aided surgical guide</description>
    <arm_group_label>Computer guided immediate implant placement</arm_group_label>
    <arm_group_label>Free hand immediate implant placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with teeth or remaining roots in the esthetic zone and indicated for extraction&#xD;
        and replacement with immediate implant.&#xD;
&#xD;
        Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2&#xD;
        mm). This will be confirmed by cone beam computer tomography (CBCT) scan.&#xD;
&#xD;
        Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this&#xD;
        will be confirmed on the study cast.&#xD;
&#xD;
        Presence of adjacent teeth to the tooth or remaining root to be extracted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g.&#xD;
        clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root&#xD;
        that will be extracted.&#xD;
&#xD;
        Severe overeruption of the opposing teeth to avoid premature contact with the temporary&#xD;
        crown during the healing period.&#xD;
&#xD;
        Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere&#xD;
        with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy,&#xD;
        radiotherapy. Osteonecrosis…)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Safaa hussein</name>
      <address>
        <city>Cairo</city>
        <zip>0000</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.</citation>
    <PMID>15248886</PMID>
  </reference>
  <reference>
    <citation>Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.</citation>
    <PMID>18332753</PMID>
  </reference>
  <results_reference>
    <citation>Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.</citation>
    <PMID>26266220</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Safaa Kamel Hussein</investigator_full_name>
    <investigator_title>Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>computer guided</keyword>
  <keyword>immediate implant</keyword>
  <keyword>patient satisfaction</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/NCT03230500
org study id: Faculty of Dentistry
nct id: NCT03230500
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone
      will be recruited to the study. After extraction of the tooth implant will be placed
      immediately, implants will be placed either by free hand or computer guided technique.
      patient satisfaction will be evaluated as primary outcome and early implant failure was
      evaluated as secondary outcome.
General operative procedures:

      Eligible patients will be randomized, at the surgical phase in two groups, study group (in
      which computer guided implant placement was done using computer aided surgical guide) and
      comparative group (in which free hand implant placement was done).

      Patients of both groups will be subjected to:

      Careful clinical examination and medical and dental history taking. CBCT scan will be
      performed while patients biting on cotton roll to separate the teeth of interest from
      opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip
      and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular
      alginate impression will be made for eligible patients.For temporary crown fabrication after
      the surgery, the tooth or root to be extracted will be modified on the study cast and an
      artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the
      study cast. For the test group (computer guided group), three dimensional (3d) virtual
      planning of the surgical guide and implant position will be made with the aid of Blue Sky ®
      implant planning software . After proper selection of implant size, diameter and position,
      the virtual surgical guide will be exported as a STL file for 3D printing. Before the
      surgery, adaptation of the surgical guide will be checked on the study cast and a metallic
      sleeve will be attached at proposed implant position using adhesive.

      Intraoperative procedure:

      3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day
      of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining
      root or tooth will be performed. For a traumatic extraction, gentle application of a
      periotome mesio-distally along with slight rotational movement. After extraction, intact
      labial and palatal socket walls will be checked using periodontal probe for immediate implant
      placement. For the test group, the computer aided surgical guide will be checked for
      adaptability and any interference will be removed. After that implant drilling and placement
      will be performed using the surgical guide. For the control group, free hand implant drilling
      and placement will be performed guided by the extraction socket walls. For both groups
      implant primary stability will be checked by application of 35 Ncm2 force using torque wrench
      After that, the final abutment will be screwed in its position and the temporary crown will
      be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will
      be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be
      checked for any functional contact in maximum intercuspation and lateral movement. Any
      contact with the opposing should be removed and the patient will be instructed to avoid
      eating or incising on the temporary crown for at least two weeks. Seven days later patients
      will be recalled for inspection and taking postoperative photos, six months thereafter, the
      patient will receive a definitive crown.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Due to the nature of the trial only the outcome assessor will be masked from the intervention or control group
measure: Patient satisfaction
time frame: 0-6 months
description: Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
measure: Early implant failure
time frame: 0-6 months
description: Early implant failure will be clinically diagnosed by implant loss from mouth which will be detected by visual inspection. Early implant failure will be assessed in the interval between implant placement until functional loading (0-6 months).
arm group label: Computer guided immediate implant placement
arm group type: Experimental
description: For the test group, the computer aided surgical guide will be used for implant drilling and placement.
arm group label: Free hand immediate implant placement
arm group type: Active Comparator
description: For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls.
intervention type: Procedure
intervention name: Computer guided implant placement
description: Implant will be placed immediately using computer aided surgical guide
arm group label: Computer guided immediate implant placement
arm group label: Free hand immediate implant placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.
PMID: 15248886
citation: Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
PMID: 18332753
citation: Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.
PMID: 26266220
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Safaa Kamel Hussein
investigator title: Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator
sharing ipd: No