<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/NCT03281148</url>
  </required_header>
  <id_info>
    <org_study_id>Prosthetic department</org_study_id>
    <nct_id>NCT03281148</nct_id>
  </id_info>
  <brief_title>Accuracy in Computer Guided Versus Free Hand Immediate Implantation</brief_title>
  <acronym>RCT</acronym>
  <official_title>Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled 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 hopeless teeth in the esthetic area requiring immediate implant restoration&#xD;
      will be recruited to the study. Patients will be divided into two groups; a group will&#xD;
      receive immediate implants placed using CAD/CAM guides while the other group will receive&#xD;
      immediate implants placed by free hand technique. Accuracy of inserted implants will be&#xD;
      measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventions The principal investigator (DA) will diagnose all patients and select them&#xD;
      according to inclusion and exclusion criteria.&#xD;
&#xD;
      The principal investigator (DA) will prepare all patients. Patient preparation will take few&#xD;
      steps that are important for optimum planning of implant insertion and restoration. Actual&#xD;
      treatment steps will start after preparation is done including; surgical and prosthetic&#xD;
      procedures.&#xD;
&#xD;
        1. Case history&#xD;
&#xD;
             1. Medical history:&#xD;
&#xD;
                The principal investigator (DA) will ask all patients about their present and&#xD;
                previous systemic condition and any history of hospitalization or surgeries.&#xD;
                Controlled diabetic patients will be asked to bring a recent blood glucose test.&#xD;
                This includes both fasting/post prandial &amp;glycosylated hemoglobin test (Hemoglobin&#xD;
                A1c) to evaluate their current status.&#xD;
&#xD;
             2. Dental history:&#xD;
&#xD;
                The principal investigator (DA) will ask all patients about past dental procedures&#xD;
                including implants.&#xD;
&#xD;
                b) Clinical examination&#xD;
&#xD;
             1. Visual examination:&#xD;
&#xD;
                The principal investigator (DA) will examine all patients extra orally to assess&#xD;
                the temporomandibular joints, temporalis, and masseter muscle to help in detection&#xD;
                of bruxism. Intraoral examination includes assessment of any pathological lesion&#xD;
                (cyst/tumor) that may interfere with the planned implant treatment.&#xD;
&#xD;
             2. Digital examination:&#xD;
&#xD;
                The principal investigator (DA) will examine the soft tissue surrounding hopeless&#xD;
                teeth digitally using index finger to confirm a firm mucosa free from any flabby&#xD;
                tissue, absence of severe undercuts and absence of abnormal ridge contour. The&#xD;
                principal investigator (DA) will examine the bone volume arbitrary using the two&#xD;
                index fingers to confirm an adequate bucco-lingual bone width. The principal&#xD;
                investigator (DA) will test tooth mobility of adjacent teeth using a periodontal&#xD;
                probe to ensure that the remaining adjacent teeth are not mobile.&#xD;
&#xD;
                c) Construction of scan appliance: The principal investigator (DA) will make&#xD;
                primary upper and lower impressions for the selected patients using irreversible&#xD;
                hydrocolloid impression material in stock trays of suitable sizes. The principal&#xD;
                investigator (DA) will pour impressions using Type IV extra hard dental stone . The&#xD;
                principal investigator (DA) will take a Face bow record and a diagnostic bite&#xD;
                record for each patient using Utility Wax . A semi-adjustable articulator will be&#xD;
                used for mounting.&#xD;
&#xD;
                A diagnostic mock up for broken/ badly decayed teeth will be formed for needed&#xD;
                patients. By pressing a clear thermoplastic sheet using a vacuum forming machine on&#xD;
                the study cast of the patient; a vacuum formed template will be constructed&#xD;
                containing radiopaque markers for easy superimposition later. The vacuum template&#xD;
                is now considered the scan appliance.&#xD;
&#xD;
                d) Patient Radiographic Imaging Every patient will be then sent for a CBCT scanning&#xD;
                for the upper and/or lower arch. The patient will be instructed to wear the scan&#xD;
                appliance during imaging. Midline will be adjusted using laser beam and a scout&#xD;
                will be taken to the patient. The patient will be asked to stay still till the&#xD;
                machine rotates around him/her. The cone beam computed tomography images will be&#xD;
                obtained in Digital Imaging &amp; Communications in Medicine (DICOM) format on a&#xD;
                compact disc.&#xD;
&#xD;
                e) Virtual planning and construction of surgical guide&#xD;
&#xD;
                a) Virtual Planning The CBCT image was used for the virtual surgical and prosthetic&#xD;
                planning of implant placement using Blusky® software. First, the remaining and&#xD;
                neighboring teeth will be segmented. This step helped in virtually inserting&#xD;
                implants in an acceptable position in relation to neighboring teeth with respect to&#xD;
                their crowns and roots. Virtual Setting will be done then virtual insertion of&#xD;
                implants with appropriate sizes will be done with respect to the future prosthesis.&#xD;
&#xD;
                Cautious respect to anatomical landmarks in the area of interest will be considered&#xD;
                during planning. In the mandible; Mandibular canal will be simulated to be seen in&#xD;
                both 2D and 3D views. In the maxilla; maxillary sinus lining will be checked in all&#xD;
                views during implant positioning.&#xD;
&#xD;
                A Virtual guide will be designed from the CBCT of the patient to be seated on&#xD;
                neighboring teeth. The exported Standard Language transformation (STL) file of the&#xD;
                virtual guide will be sent to labs centers by e-mail for construction.&#xD;
&#xD;
                f) Surgical Procedures: The Principal investigator (DA) will extract the remaining&#xD;
                root or tooth in an atraumatic procedure procedure using lancet, periotome, minimal&#xD;
                force and rotational movement. After extraction the socket will be examined for&#xD;
                intact labial and palatal bone using depth probe. If all walls are intact the&#xD;
                socket would be eligible for immediate implant placement.&#xD;
&#xD;
                In the test group, the computer guided surgical guide will be used for implant&#xD;
                drilling and placement following the manufacturer's instructions.&#xD;
&#xD;
                While in the control group, after tooth or root extraction implants will be placed&#xD;
                free hand guided by the extraction sockets.&#xD;
&#xD;
                Then in implants with primary stability (Insertion torque&gt; 35 Ncm2), the final&#xD;
                abutment will be placed and any further adjustment would be done immediately in the&#xD;
                lab and re-positioned in place. The principal investigator (DA) will check the&#xD;
                vacuum stent is in its place again intraorally, then a chair side tooth colored&#xD;
                auto-polymerizing resin will be injected into the vacuum sheet corresponding to the&#xD;
                implant site to construct the temporary crown.&#xD;
&#xD;
                If any subject is to feel any movement in his/her temporary crown, an immediate&#xD;
                phone call is to be done to (DA) to examine the cause of mobility (whether it is&#xD;
                the crown only or the implant itself).&#xD;
&#xD;
                g) Postoperative Care: The principal investigator (DA) will manage postoperative&#xD;
                complications. The principal investigator (DA) will remove mobile temporary crowns&#xD;
                and recement them. While mobile implants will be considered as early stage failed&#xD;
                implants and it will be removed immediately. The patient will receive another&#xD;
                implant at the same site after a proper healing period of at least 3 months during&#xD;
                which he/she will be provided with a temporary removable partial denture for&#xD;
                aesthetics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear Deviation</measure>
    <time_frame>two months postoperative</time_frame>
    <description>The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Immediate Dental Implants</condition>
  <arm_group>
    <arm_group_label>Computer guided implant insertion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Free hand implant insertion group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer guided implant insertion group</intervention_name>
    <description>Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides</description>
    <arm_group_label>Computer guided implant insertion group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Free hand implant insertion group</intervention_name>
    <description>Implants will be immediately inserted in fresh extraction sockets using free hand technique</description>
    <arm_group_label>Free hand implant insertion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with hopeless teeth or remaining roots&#xD;
&#xD;
          2. Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)&#xD;
&#xD;
          3. Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)&#xD;
&#xD;
          4. Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)&#xD;
&#xD;
          5. Adults more than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled diabetic patients (HbA1c value ≥ 8.1 percent) (Takeshita et al.,&#xD;
             1998)(Javed &amp; Romanos, 2009)(Garg, 2010)(Retzepi &amp; Donos, 2010)(B R Chrcanovic et al.,&#xD;
             2014)&#xD;
&#xD;
          2. Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et&#xD;
             al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)&#xD;
&#xD;
          3. Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al.,&#xD;
             2012)(Zhou et al., 2015)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maha ElKerdawy, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Professor at Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Doaa Mohammed Ayman, PhD</last_name>
    <phone>02001285463772</phone>
    <email>do3aa2@live.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doaa Ayman, PhD</last_name>
    <phone>02001285463772</phone>
    <email>doaa.auf@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>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), 391-398. http://doi.org/10.1002/smll.)) D'haese, J., Van De Velde, T., Komiyama, A., Hultin, M., &amp; De Bruyn, H. (2012). Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clinical Implant Dentistry and Related Research, 14(3), 321-35. http://doi.org/10.1111/j.1708-8208.2010.00275.x Ortega-martínez, J., Pérez-pascual, T., Mareque-bueno, S., &amp; Hernández-alfaro, F. (2012). Immediate implants following tooth extraction . A systematic review. Medicina Oral Patología Oral Y Cirugia Bucal- Oral Surgery Section, 17(2), e251-61. http://doi.org/10.4317/medoral.17469</citation>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Doaa Mohammed Ayman</investigator_full_name>
    <investigator_title>Assistant lecturer at Prosthodontic Department Faculty of Dentistry</investigator_title>
  </responsible_party>
  <keyword>immediate implants, accuracy,extraction sockets</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/NCT03281148
org study id: Prosthetic department
nct id: NCT03281148
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with hopeless teeth in the esthetic area requiring immediate implant restoration
      will be recruited to the study. Patients will be divided into two groups; a group will
      receive immediate implants placed using CAD/CAM guides while the other group will receive
      immediate implants placed by free hand technique. Accuracy of inserted implants will be
      measured.
Interventions The principal investigator (DA) will diagnose all patients and select them
      according to inclusion and exclusion criteria.

      The principal investigator (DA) will prepare all patients. Patient preparation will take few
      steps that are important for optimum planning of implant insertion and restoration. Actual
      treatment steps will start after preparation is done including; surgical and prosthetic
      procedures.

        1. Case history

             1. Medical history:

                The principal investigator (DA) will ask all patients about their present and
                previous systemic condition and any history of hospitalization or surgeries.
                Controlled diabetic patients will be asked to bring a recent blood glucose test.
                This includes both fasting/post prandial &glycosylated hemoglobin test (Hemoglobin
                A1c) to evaluate their current status.

             2. Dental history:

                The principal investigator (DA) will ask all patients about past dental procedures
                including implants.

                b) Clinical examination

             1. Visual examination:

                The principal investigator (DA) will examine all patients extra orally to assess
                the temporomandibular joints, temporalis, and masseter muscle to help in detection
                of bruxism. Intraoral examination includes assessment of any pathological lesion
                (cyst/tumor) that may interfere with the planned implant treatment.

             2. Digital examination:

                The principal investigator (DA) will examine the soft tissue surrounding hopeless
                teeth digitally using index finger to confirm a firm mucosa free from any flabby
                tissue, absence of severe undercuts and absence of abnormal ridge contour. The
                principal investigator (DA) will examine the bone volume arbitrary using the two
                index fingers to confirm an adequate bucco-lingual bone width. The principal
                investigator (DA) will test tooth mobility of adjacent teeth using a periodontal
                probe to ensure that the remaining adjacent teeth are not mobile.

                c) Construction of scan appliance: The principal investigator (DA) will make
                primary upper and lower impressions for the selected patients using irreversible
                hydrocolloid impression material in stock trays of suitable sizes. The principal
                investigator (DA) will pour impressions using Type IV extra hard dental stone . The
                principal investigator (DA) will take a Face bow record and a diagnostic bite
                record for each patient using Utility Wax . A semi-adjustable articulator will be
                used for mounting.

                A diagnostic mock up for broken/ badly decayed teeth will be formed for needed
                patients. By pressing a clear thermoplastic sheet using a vacuum forming machine on
                the study cast of the patient; a vacuum formed template will be constructed
                containing radiopaque markers for easy superimposition later. The vacuum template
                is now considered the scan appliance.

                d) Patient Radiographic Imaging Every patient will be then sent for a CBCT scanning
                for the upper and/or lower arch. The patient will be instructed to wear the scan
                appliance during imaging. Midline will be adjusted using laser beam and a scout
                will be taken to the patient. The patient will be asked to stay still till the
                machine rotates around him/her. The cone beam computed tomography images will be
                obtained in Digital Imaging & Communications in Medicine (DICOM) format on a
                compact disc.

                e) Virtual planning and construction of surgical guide

                a) Virtual Planning The CBCT image was used for the virtual surgical and prosthetic
                planning of implant placement using Blusky® software. First, the remaining and
                neighboring teeth will be segmented. This step helped in virtually inserting
                implants in an acceptable position in relation to neighboring teeth with respect to
                their crowns and roots. Virtual Setting will be done then virtual insertion of
                implants with appropriate sizes will be done with respect to the future prosthesis.

                Cautious respect to anatomical landmarks in the area of interest will be considered
                during planning. In the mandible; Mandibular canal will be simulated to be seen in
                both 2D and 3D views. In the maxilla; maxillary sinus lining will be checked in all
                views during implant positioning.

                A Virtual guide will be designed from the CBCT of the patient to be seated on
                neighboring teeth. The exported Standard Language transformation (STL) file of the
                virtual guide will be sent to labs centers by e-mail for construction.

                f) Surgical Procedures: The Principal investigator (DA) will extract the remaining
                root or tooth in an atraumatic procedure procedure using lancet, periotome, minimal
                force and rotational movement. After extraction the socket will be examined for
                intact labial and palatal bone using depth probe. If all walls are intact the
                socket would be eligible for immediate implant placement.

                In the test group, the computer guided surgical guide will be used for implant
                drilling and placement following the manufacturer's instructions.

                While in the control group, after tooth or root extraction implants will be placed
                free hand guided by the extraction sockets.

                Then in implants with primary stability (Insertion torque> 35 Ncm2), the final
                abutment will be placed and any further adjustment would be done immediately in the
                lab and re-positioned in place. The principal investigator (DA) will check the
                vacuum stent is in its place again intraorally, then a chair side tooth colored
                auto-polymerizing resin will be injected into the vacuum sheet corresponding to the
                implant site to construct the temporary crown.

                If any subject is to feel any movement in his/her temporary crown, an immediate
                phone call is to be done to (DA) to examine the cause of mobility (whether it is
                the crown only or the implant itself).

                g) Postoperative Care: The principal investigator (DA) will manage postoperative
                complications. The principal investigator (DA) will remove mobile temporary crowns
                and recement them. While mobile implants will be considered as early stage failed
                implants and it will be removed immediately. The patient will receive another
                implant at the same site after a proper healing period of at least 3 months during
                which he/she will be provided with a temporary removable partial denture for
                aesthetics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Linear Deviation
time frame: two months postoperative
description: The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.
arm group label: Computer guided implant insertion group
arm group type: Experimental
description: According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.
arm group label: Free hand implant insertion group
arm group type: Active Comparator
description: According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.
intervention type: Device
intervention name: Computer guided implant insertion group
description: Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides
arm group label: Computer guided implant insertion group
intervention type: Device
intervention name: Free hand implant insertion group
description: Implants will be immediately inserted in fresh extraction sockets using free hand technique
arm group label: Free hand implant insertion group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maha ElKerdawy, Professor
role: Study Chair
affiliation: Professor at Faculty of Dentistry
last name: Doaa Mohammed Ayman, PhD
phone: 02001285463772
email: do3aa2@live.com
last name: Doaa Ayman, PhD
phone: 02001285463772
email: doaa.auf@dentistry.cu.edu.eg
citation: 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), 391-398. http://doi.org/10.1002/smll.)) D'haese, J., Van De Velde, T., Komiyama, A., Hultin, M., & De Bruyn, H. (2012). Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clinical Implant Dentistry and Related Research, 14(3), 321-35. http://doi.org/10.1111/j.1708-8208.2010.00275.x Ortega-martínez, J., Pérez-pascual, T., Mareque-bueno, S., & Hernández-alfaro, F. (2012). Immediate implants following tooth extraction . A systematic review. Medicina Oral Patología Oral Y Cirugia Bucal- Oral Surgery Section, 17(2), e251-61. http://doi.org/10.4317/medoral.17469
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Doaa Mohammed Ayman
investigator title: Assistant lecturer at Prosthodontic Department Faculty of Dentistry
sharing ipd: No