xml: <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/NCT05983718</url>
    </required_header>
    <id_info>
      <org_study_id>BME-BUET-DDCH-001</org_study_id>
      <nct_id>NCT05983718</nct_id>
    </id_info>
    <brief_title>A Study of Surgical Guide Assisted Dental Implantation in Bangladesh</brief_title>
    <official_title>Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dhaka Dental College and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bangladesh University of Engineering and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dhaka Dental College and Hospital</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>
        This is a randomized controlled study that aims to compare the accuracy between full-guided&#xD;
        with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each&#xD;
        case is the comparison of the preoperative digital plan with the actual postoperative status.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial&#xD;
        teeth that are aesthetically and functionally similar to natural teeth. For a successful&#xD;
        implant surgery, it is necessary to use digital planning software in conjunction with a&#xD;
        cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like&#xD;
        Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant&#xD;
        surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut&#xD;
        the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and&#xD;
        location. Then they perform implant surgery following the hole created by the guide pin,&#xD;
        similar to free-hand surgery. But the overall procedure is still highly invasive and has low&#xD;
        accuracy.&#xD;
  &#xD;
        Free-hand implant surgeries are still in practice everywhere. The application of a guide pin&#xD;
        has been observed in some places to enhance the situation. A guide pin helps an operator&#xD;
        recognize the position and angle of an alveolar bone when forming an implantation hole in the&#xD;
        alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the&#xD;
        implant site with minimal incision and then confirm the desired direction and location with a&#xD;
        radiographic image. However, we need a proper clinical evaluation to compare fully-guided&#xD;
        surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.&#xD;
  &#xD;
        The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing&#xD;
        dental software and guided surgery has already achieved higher acceptance in implant surgery.&#xD;
        Several patients from several privileged parts of the world benefit from surgical guides. But&#xD;
        the usual design convention includes intraoral scanner data with CBCT. However, intraoral&#xD;
        scanners are still unavailable in many dental hospitals. The study is designed to address the&#xD;
        precision of dental implant surgeries worldwide, especially where the intraoral scanner is&#xD;
        not present. In our research, we will focus on partially edentulous patients. And our design&#xD;
        procedure will not be dependent on intra-oral scanner data. As partially edentulous patients&#xD;
        are higher in number and CBCT machines readily available in hospitals, this study can open up&#xD;
        a way to address the scarcity of intra-oral scanner data to avail a large number of implant&#xD;
        patients with an effective guide. The success rate of this study will encourage us not only&#xD;
        to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but&#xD;
        also to significantly impact the execution of implant surgeries in developing countries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>Parallel Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Angular deviation</measure>
      <time_frame>3 months</time_frame>
      <description>The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Apical deviation</measure>
      <time_frame>3 months</time_frame>
      <description>The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coronal deviation</measure>
      <time_frame>3 months</time_frame>
      <description>The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Partially Edentulous Mandible</condition>
    <condition>Dental Implantation</condition>
    <arm_group>
      <arm_group_label>FREE HAND (GUIDE-PIN-assisted)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>FULL GUIDED</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Surgical Guide</intervention_name>
      <description>For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.</description>
      <arm_group_label>FULL GUIDED</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Guide-pin-assisted Freehand surgery</intervention_name>
      <description>The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.</description>
      <arm_group_label>FREE HAND (GUIDE-PIN-assisted)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of age between 18 to 75 and of any gender&#xD;
  &#xD;
            -  Patient fit for implantation (satisfactory soft and hard tissue conditions and&#xD;
               occlusion)&#xD;
  &#xD;
            -  Partially edentulous of the mandible patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with pregnancy&#xD;
  &#xD;
            -  Patient with uncontrolled diabetes mellitus.&#xD;
  &#xD;
            -  Patient who needed dentoalveolar or associated soft tissue reconstruction procedure&#xD;
  &#xD;
            -  Patient taking bisphosphonate or have any history of systemic or local bone disease&#xD;
  &#xD;
            -  Recent extracted sites&#xD;
  &#xD;
            -  Patients with a history of smoking, alcoholism&#xD;
  &#xD;
            -  Patient with a history of head-neck radiation&#xD;
  &#xD;
            -  Patient with associated periapical pathology or history of parafunctional habit&#xD;
  &#xD;
            -  Patient needs bone grafting.&#xD;
  &#xD;
            -  Known HIV, Hepatitis B, or Hepatitis C infection.&#xD;
  &#xD;
            -  Limited mouth opening, which, in the examiner's opinion, would risk the success of the&#xD;
               intervention&#xD;
  &#xD;
            -  Local infection&#xD;
  &#xD;
            -  Known allergy to any component of the implant or the implant guide&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dhaka Dental College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)</last_name>
      <phone>+8801715748863</phone>
      <email>dr.sarkar.bds@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.</last_name>
      <phone>+8801911764467</phone>
      <email>tarikarafat@bme.buet.ac.bd</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dhaka Dental College and Hospital</name>
        <address>
          <city>Dhaka</city>
          <zip>1206</zip>
          <country>Bangladesh</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Md. Al-Amin Sarkar</last_name>
        <phone>+8801715748863</phone>
        <email>dr.sarkar.bds@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Dr. Mst. Jannatul Ferdous</last_name>
        <phone>+88029038266</phone>
        <email>ddch@hospi.dghs.gov.bd</email>
      </contact_backup>
      <investigator>
        <last_name>Dr. Md. Al-Amin Sarkar, BDS, FCPS (Prosthodontics)</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Taufiq Hasan Al Banna, B.Sc., M.Sc., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Jahid Ferdous, B.Sc., M.Sc., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Mst. Jannatul Ferdous, BDS, MS (Prosthodontics)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Ashik Abdullah, BDS, MS (OMS)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Tasrif Ahmed, BDS, MS (OMS)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <reference>
      <citation>Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96. doi: 10.1902/jop.1988.59.5.287.</citation>
      <PMID>3290429</PMID>
    </reference>
    <reference>
      <citation>Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.</citation>
      <PMID>12357184</PMID>
    </reference>
    <reference>
      <citation>Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Depth deviation and occurrence of early surgical complications or unexpected events using a single stereolithographic surgi-guide. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1377-87. doi: 10.1016/j.ijom.2011.09.009. Epub 2011 Oct 15.</citation>
      <PMID>22001378</PMID>
    </reference>
    <reference>
      <citation>Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital Medicine: A Primer on Measurement. Digit Biomark. 2019 May 9;3(2):31-71. doi: 10.1159/000500413. eCollection 2019 May-Aug.</citation>
      <PMID>32095767</PMID>
    </reference>
    <reference>
      <citation>Geng W, Liu C, Su Y, Li J, Zhou Y. Accuracy of different types of computer-aided design/computer-aided manufacturing surgical guides for dental implant placement. Int J Clin Exp Med. 2015 Jun 15;8(6):8442-9. eCollection 2015.</citation>
      <PMID>26309497</PMID>
    </reference>
    <reference>
      <citation>Israelson H, Plemons JM, Watkins P, Sory C. Barium-coated surgical stents and computer-assisted tomography in the preoperative assessment of dental implant patients. Int J Periodontics Restorative Dent. 1992;12(1):52-61.</citation>
      <PMID>1526711</PMID>
    </reference>
    <reference>
      <citation>Jacobs R, Adriansens A, Verstreken K, Suetens P, van Steenberghe D. Predictability of a three-dimensional planning system for oral implant surgery. Dentomaxillofac Radiol. 1999 Mar;28(2):105-11. doi: 10.1038/sj/dmfr/4600419.</citation>
      <PMID>10522199</PMID>
    </reference>
    <reference>
      <citation>Jacobs R, Adriansens A, Naert I, Quirynen M, Hermans R, Van Steenberghe D. Predictability of reformatted computed tomography for pre-operative planning of endosseous implants. Dentomaxillofac Radiol. 1999 Jan;28(1):37-41. doi: 10.1038/sj.dmfr.4600403.</citation>
      <PMID>10202477</PMID>
    </reference>
    <reference>
      <citation>Kernen F, Benic GI, Payer M, Schar A, Muller-Gerbl M, Filippi A, Kuhl S. Accuracy of Three-Dimensional Printed Templates for Guided Implant Placement Based on Matching a Surface Scan with CBCT. Clin Implant Dent Relat Res. 2016 Aug;18(4):762-8. doi: 10.1111/cid.12348. Epub 2015 Apr 28.</citation>
      <PMID>25923363</PMID>
    </reference>
    <reference>
      <citation>Kiatkroekkrai P, Takolpuckdee C, Subbalekha K, Mattheos N, Pimkhaokham A. Accuracy of implant position when placed using static computer-assisted implant surgical guides manufactured with two different optical scanning techniques: a randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Mar;49(3):377-383. doi: 10.1016/j.ijom.2019.08.019. Epub 2019 Sep 20.</citation>
      <PMID>31543382</PMID>
    </reference>
    <reference>
      <citation>Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.</citation>
      <PMID>32151043</PMID>
    </reference>
    <reference>
      <citation>Schneider D, Marquardt P, Zwahlen M, Jung RE. A systematic review on the accuracy and the clinical outcome of computer-guided template-based implant dentistry. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:73-86. doi: 10.1111/j.1600-0501.2009.01788.x.</citation>
      <PMID>19663953</PMID>
    </reference>
    <reference>
      <citation>Verstreken K, Van Cleynenbreugel J, Martens K, Marchal G, van Steenberghe D, Suetens P. An image-guided planning system for endosseous oral implants. IEEE Trans Med Imaging. 1998 Oct;17(5):842-52. doi: 10.1109/42.736056.</citation>
      <PMID>9874310</PMID>
    </reference>
    <reference>
      <citation>Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.</citation>
      <PMID>29608793</PMID>
    </reference>
    <reference>
      <citation>D'haese J, Van De Velde T, Komiyama A, Hultin M, De Bruyn H. Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clin Implant Dent Relat Res. 2012 Jun;14(3):321-35. doi: 10.1111/j.1708-8208.2010.00275.x. Epub 2010 May 11.</citation>
      <PMID>20491822</PMID>
    </reference>
    <reference>
      <citation>Wang X, Ji X. Sample Size Estimation in Clinical Research: From Randomized Controlled Trials to Observational Studies. Chest. 2020 Jul;158(1S):S12-S20. doi: 10.1016/j.chest.2020.03.010.</citation>
      <PMID>32658647</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dhaka Dental College and Hospital</investigator_affiliation>
      <investigator_full_name>Dr. Md. Al-Amin Sarkar</investigator_full_name>
      <investigator_title>Junior Consultant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mouth, Edentulous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983718
  org study id: BME-BUET-DDCH-001
  nct id: NCT05983718
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized controlled study that aims to compare the accuracy between full-guided
        with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each
        case is the comparison of the preoperative digital plan with the actual postoperative status.
  Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial
        teeth that are aesthetically and functionally similar to natural teeth. For a successful
        implant surgery, it is necessary to use digital planning software in conjunction with a
        cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like
        Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant
        surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut
        the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and
        location. Then they perform implant surgery following the hole created by the guide pin,
        similar to free-hand surgery. But the overall procedure is still highly invasive and has low
        accuracy.
  
        Free-hand implant surgeries are still in practice everywhere. The application of a guide pin
        has been observed in some places to enhance the situation. A guide pin helps an operator
        recognize the position and angle of an alveolar bone when forming an implantation hole in the
        alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the
        implant site with minimal incision and then confirm the desired direction and location with a
        radiographic image. However, we need a proper clinical evaluation to compare fully-guided
        surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.
  
        The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing
        dental software and guided surgery has already achieved higher acceptance in implant surgery.
        Several patients from several privileged parts of the world benefit from surgical guides. But
        the usual design convention includes intraoral scanner data with CBCT. However, intraoral
        scanners are still unavailable in many dental hospitals. The study is designed to address the
        precision of dental implant surgeries worldwide, especially where the intraoral scanner is
        not present. In our research, we will focus on partially edentulous patients. And our design
        procedure will not be dependent on intra-oral scanner data. As partially edentulous patients
        are higher in number and CBCT machines readily available in hospitals, this study can open up
        a way to address the scarcity of intra-oral scanner data to avail a large number of implant
        patients with an effective guide. The success rate of this study will encourage us not only
        to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but
        also to significantly impact the execution of implant surgeries in developing countries.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Angular deviation
  time frame: 3 months
  description: The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.
  measure: Apical deviation
  time frame: 3 months
  description: The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.
  measure: Coronal deviation
  time frame: 3 months
  description: The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.
  arm group label: FREE HAND (GUIDE-PIN-assisted)
  arm group type: Active Comparator
  arm group label: FULL GUIDED
  arm group type: Experimental
  intervention type: Device
  intervention name: Surgical Guide
  description: For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
  arm group label: FULL GUIDED
  intervention type: Procedure
  intervention name: Guide-pin-assisted Freehand surgery
  description: The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
  arm group label: FREE HAND (GUIDE-PIN-assisted)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
  role: Principal Investigator
  affiliation: Dhaka Dental College Hospital
  last name: Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
  phone: +8801715748863
  email: dr.sarkar.bds@gmail.com
  last name: Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.
  phone: +8801911764467
  email: tarikarafat@bme.buet.ac.bd
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Bangladesh
  citation: Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96. doi: 10.1902/jop.1988.59.5.287.
  PMID: 3290429
  citation: Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.
  PMID: 12357184
  citation: Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Depth deviation and occurrence of early surgical complications or unexpected events using a single stereolithographic surgi-guide. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1377-87. doi: 10.1016/j.ijom.2011.09.009. Epub 2011 Oct 15.
  PMID: 22001378
  citation: Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital Medicine: A Primer on Measurement. Digit Biomark. 2019 May 9;3(2):31-71. doi: 10.1159/000500413. eCollection 2019 May-Aug.
  PMID: 32095767
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  responsible party type: Principal Investigator
  investigator affiliation: Dhaka Dental College and Hospital
  investigator full name: Dr. Md. Al-Amin Sarkar
  investigator title: Junior Consultant
  mesh term: Mouth, Edentulous
  sharing ipd: No