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/NCT05985226</url>
    </required_header>
    <id_info>
      <org_study_id>C.I. 22/645-E</org_study_id>
      <nct_id>NCT05985226</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of the Effect of the Scanning Pattern on Complete-arch Implant Scans</brief_title>
    <acronym>strategiesIOS</acronym>
    <official_title>Clinical Evaluation of the Effect of the Scanning Pattern on Complete-arch Implant Scans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Complutense de Madrid</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Complutense de Madrid</source>
    <oversight_info>
      <has_dmc>No</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 clinical trial aims to analyze and compare the influence of different scanning&#xD;
        strategies (zigzag with conventional scan body, circumferential with conventional scan body,&#xD;
        surface blocking with conventional scan body, zigzag with low profile scan body, standard&#xD;
        strategy with low profile scan body) on the accuracy of the records obtained for a case of&#xD;
        fixed rehabilitation on full-arch dental implants in patients of both sexes, over 18 years of&#xD;
        age who will be rehabilitated with fixed prostheses on full-arch implants.&#xD;
  &#xD;
        The main question it aims to answer is if there will be significant differences in scanning&#xD;
        accuracy (trueness and precision) between the different groups of digital impressions&#xD;
        compared to the reference model (conventional impression with rigid splinting) and types of&#xD;
        scan bodies.&#xD;
  &#xD;
        The patient will undergo conventional impression-taking (with pastes) to obtain the reference&#xD;
        model. Subsequently, digital records will be taken with the intra-oral scanner until&#xD;
        completing 15 records per group, out of a total of 6 experimental groups (1.- zigzag with&#xD;
        conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.-&#xD;
        surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body&#xD;
        (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with&#xD;
        low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the&#xD;
        patient's mouth, to later be compared with the reference model, called the &quot;master model&quot;.&#xD;
  &#xD;
        Researchers will compare the six different methodologies for taking digital impressions to&#xD;
        demonstrate which strategies are more accurate, faster, and require fewer frames.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        INTRODUCTION AND BACKGROUND Record-taking is a fundamental process and the starting point for&#xD;
        manufacturing a dental prosthesis. The appearance of intraoral scanners (IntraOral Scanners&#xD;
        (IOS)) has meant a revolution in this regard due to the advantages they provide, including&#xD;
        better communication with both the patient and the dental laboratory, better comfort and&#xD;
        acceptance by the patient, the immediacy in sending the file and saving space in the storage&#xD;
        of digital models versus conventional ones. However, they are not exempt from problems,&#xD;
        including their high cost, the learning curve, and difficulty achieving a reliable record in&#xD;
        certain circumstances, including edentulous full-arch records.&#xD;
  &#xD;
        Recordings of the edentulous full arch with IOSs pose a challenge due to the type of&#xD;
        operation of these devices, which gradually collect and overlap information from small areas&#xD;
        until completing a full arch. For this reason, different techniques have been proposed to&#xD;
        improve the accuracy of this type of recording. In addition, if there is a case in which&#xD;
        accuracy is crucial, it is complete edentulous arches with implants since, if the&#xD;
        registration is not exact, the prosthesis manufactured on it will not have a passive fit in&#xD;
        the mouth, which would lead to the appearance of both biological and mechanical&#xD;
        complications.&#xD;
  &#xD;
        Different studies have tried to analyze how various factors influence this accuracy, and&#xD;
        these factors can be divided into factors related to the operator, the scanner, environmental&#xD;
        conditions, or intraoral conditions-also different scanning strategies or heights and&#xD;
        positions of the scan bodies. However, most of these works have been developed in an in vitro&#xD;
        environment. This fact is motivated by the greater ease of making the records and, as a more&#xD;
        relevant fact, the possibility of obtaining a reliable reference model, employing a&#xD;
        coordinate machine (Coordinate Measurement Machine (CMM)) or a desktop scanner, something&#xD;
        that in an in vivo study it is not possible.&#xD;
  &#xD;
        The present study aims to clinically analyze the accuracy of different intraoral scanning&#xD;
        strategies and types of scan bodies in edentulous full arch registrations on implants.&#xD;
  &#xD;
        JUSTIFICATION Due to the importance of the accuracy in taking digital impressions in&#xD;
        full-arch patients for the fabrication of restorations on implants, it is considered&#xD;
        justified to study the influence of different scanning strategies and scan bodies on the&#xD;
        accuracy of full-arch recording.&#xD;
  &#xD;
        VIABILITY The project could be considered viable by having all the instruments and apparatus&#xD;
        necessary to develop the material and methods. It is estimated that the proposed methodology&#xD;
        could be developed within the period described.&#xD;
  &#xD;
        AIM The purpose of this in vivo study will be to measure the influence of different scanning&#xD;
        strategies (zigzag with conventional scan body, circumferential with conventional scan body,&#xD;
        surface blocking with conventional scan body, zigzag with low profile scan body, standard&#xD;
        strategy with low profile scan body) on the accuracy of the records obtained for a case of&#xD;
        fixed rehabilitation on full-arch dental implants.&#xD;
  &#xD;
        HYPOTHESIS The null hypothesis will be that there are no significant differences in scanning&#xD;
        accuracy (trueness and precision) between the different groups of digital impressions&#xD;
        compared to the reference model (conventional impression with rigid splinting).&#xD;
  &#xD;
        The alternative hypothesis will be that there are significant differences in scanning&#xD;
        accuracy (trueness and precision) between the different groups of digital impressions&#xD;
        compared to the reference model (conventional impression with rigid splinting).&#xD;
  &#xD;
        MATERIAL AND METHOD A patient will be selected who is susceptible to rehabilitation with a&#xD;
        fixed prosthesis on implants, in good general health (ASA I and ASA II), without joint&#xD;
        problems or limitation of opening, and who, after reading the information sheet, the patient&#xD;
        and informed consent, and clarified any doubts, voluntarily agree to participate in the&#xD;
        study.&#xD;
  &#xD;
        A reference model will be taken with a high-precision conventional methodology such as Rigid&#xD;
        Impression Splinting. A first impression will be taken with double-mix addition silicone&#xD;
        (putty and fluid) with an open tray. From this record, a first model will be generated that&#xD;
        will be used to splint the impression transfers with a rigid, low-shrinkage light-curing&#xD;
        material, which will later be sectioned with discs. Subsequently, the transfers will be&#xD;
        screwed with the splint in the mouth and rejoined using a low-shrinkage light-curing&#xD;
        material, thus minimizing the possibility of accumulation of errors. A second impression will&#xD;
        be taken dragging the entire set, and it will be cast in improved type IV plaster (GC&#xD;
        Fujirock; GC), thus obtaining the master model. This model will be digitized using a&#xD;
        laboratory scanner to get the reference digital model, against which the specimens resulting&#xD;
        from the experimental groups will be compared.&#xD;
  &#xD;
        Six experimental groups will be created based on the strategy-scan body used (1.- zigzag with&#xD;
        conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.-&#xD;
        surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body&#xD;
        (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with&#xD;
        low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the&#xD;
        patient's mouth, to be compared with the reference model, called the &quot;master model&quot;.&#xD;
  &#xD;
        Based on previous studies, a sample size of n=15 is estimated for each group. A pilot study&#xD;
        will be carried out with n=5, from which a statistical test (G* Power; University of&#xD;
        Düsseldorf) will be carried out to calculate the sample size. All digitization procedures&#xD;
        will be performed under lighting conditions of 1000 lux measured with a lux meter (LX1330B&#xD;
        Light Meter; Dr. Meter Digital Illuminance) and at a constant temperature of 24 +/-2 ºC. Once&#xD;
        the files are obtained, they will be exported with the reference format for a&#xD;
        3-dimensional.STL (standard tessellation language) file to a metrology program (Geomagic&#xD;
        Control X). The results will be compared with a reference file, and the deviations of the&#xD;
        implant positions will be obtained using the best-fit algorithm. The mean square error (Root&#xD;
        Mean Square) will be calculated.&#xD;
  &#xD;
        statistical plan Statistical tests will be developed to check the normal distribution of the&#xD;
        samples, Shapiro-Wilk or Kolmogorov-Smirnov type. A priori tests will be carried out to&#xD;
        verify the existence of statistically significant differences, and a posteriori for analyzing&#xD;
        which groups such differences appear and their magnitude. Statistical power will be 95%, so&#xD;
        those with p&lt;.05 will be considered statistically significant differences. All statistical&#xD;
        analysis will be performed using a statistical software program (IBM SPSS Statistics for&#xD;
        Windows, v26; IBM Corp).&#xD;
  &#xD;
        VARIABLES COLLECTED AND DESCRIPTION OF THE ACTIONS TO BE CARRIED OUT AND FINAL DESTINATION OF&#xD;
        THE SAMPLES The collected variable is the discrepancy in the position of the implants between&#xD;
        the control model, reference, and the experimental groups, quantified as a Root Mean Square.&#xD;
        The samples, in this case, files, will be saved anonymously on a hard drive, named so that&#xD;
        the group to which they belong and the number of samples can be interpreted (Example:&#xD;
        ZZ-SBL1). The scanning time and the number of frames will also be collected.&#xD;
  &#xD;
        SCHEDULE December 2022-March 2023: collection, sample preparation, development of&#xD;
        experimental methodology, and data collection.&#xD;
  &#xD;
        April 2023-July 2023: Statistical analysis and writing of the manuscript.&#xD;
  &#xD;
        ETHICAL IMPLICATIONS To the best of the research team's knowledge, the most significant&#xD;
        ethical implication lies in carrying out several recordings of the same patient. In this&#xD;
        regard, it should be noted that, in addition to meeting the inclusion requirements, the&#xD;
        participant wishes to participate completely voluntarily and know that the participant will&#xD;
        not obtain any compensation, financial or in any other way. On the other hand, we must bear&#xD;
        in mind that intraoral record-taking procedures with intraoral scanners can be considered&#xD;
        harmless and painless, which simply means that the patient must keep his mouth open during&#xD;
        the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Accuracy</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Micrometers (root mean square deviations)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of photograms</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Number of images</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clinical scan time</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Seconds (s)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">1</enrollment>
    <condition>Dental Prosthesis, Implant-Supported</condition>
    <arm_group>
      <arm_group_label>scanning strategies</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 experimental groups will be created based on the strategy-scan body used (1.- zigzag with conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.- surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the patient's mouth, to later be compared with the reference model, called the &quot;master model&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>intraoral scan</intervention_name>
      <description>All the experimental groups will be developed with an intraoral scanner, a device that emits light and collects the image projected by that light, to build a 3-dimensional digital model. It is more comfortable than conventional impressions and it is a harmless, non-intrusive, and painless procedure.</description>
      <arm_group_label>scanning strategies</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient susceptible to rehabilitation with a fixed prosthesis on implants.&#xD;
  &#xD;
            -  Good general health (ASA I and ASA II),&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Joint problems or limitation of opening.&#xD;
  &#xD;
            -  Patients who, after reading the information sheet the patient and informed consent,&#xD;
               and clarified any doubts, do not agree to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Miguel Gómez-Polo, PhD, DDS</last_name>
      <role>Study Director</role>
      <affiliation>Universidad Complutense de Madrid</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Miguel Gómez-Polo, PhD, DDS</last_name>
      <phone>+34 659390001</phone>
      <email>mgomezpo@ucm.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Miguel Gómez-Polo</last_name>
      <phone>+34 659390001</phone>
      <email>mgomezpo@ucm.es</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>School of Dentistry, Complutense University. Pza Ramón y Cajal s/n.</name>
        <address>
          <city>Madrid</city>
          <zip>28040</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miguel Gómez Polo, DDS, PhD</last_name>
        <phone>+34659390001</phone>
        <email>mgomezpo@ucm.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
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    <verification_date>November 2022</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Accuracy</keyword>
    <keyword>intraoral scanners</keyword>
    <keyword>digital impressions</keyword>
    <keyword>complete arch</keyword>
    <keyword>implant-supported dental prostheses</keyword>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>November 23, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT05985226/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>November 23, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT05985226/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05985226
  org study id: C.I. 22/645-E
  nct id: NCT05985226
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to analyze and compare the influence of different scanning
        strategies (zigzag with conventional scan body, circumferential with conventional scan body,
        surface blocking with conventional scan body, zigzag with low profile scan body, standard
        strategy with low profile scan body) on the accuracy of the records obtained for a case of
        fixed rehabilitation on full-arch dental implants in patients of both sexes, over 18 years of
        age who will be rehabilitated with fixed prostheses on full-arch implants.
  
        The main question it aims to answer is if there will be significant differences in scanning
        accuracy (trueness and precision) between the different groups of digital impressions
        compared to the reference model (conventional impression with rigid splinting) and types of
        scan bodies.
  
        The patient will undergo conventional impression-taking (with pastes) to obtain the reference
        model. Subsequently, digital records will be taken with the intra-oral scanner until
        completing 15 records per group, out of a total of 6 experimental groups (1.- zigzag with
        conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.-
        surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body
        (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with
        low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the
        patient's mouth, to later be compared with the reference model, called the "master model".
  
        Researchers will compare the six different methodologies for taking digital impressions to
        demonstrate which strategies are more accurate, faster, and require fewer frames.
  INTRODUCTION AND BACKGROUND Record-taking is a fundamental process and the starting point for
        manufacturing a dental prosthesis. The appearance of intraoral scanners (IntraOral Scanners
        (IOS)) has meant a revolution in this regard due to the advantages they provide, including
        better communication with both the patient and the dental laboratory, better comfort and
        acceptance by the patient, the immediacy in sending the file and saving space in the storage
        of digital models versus conventional ones. However, they are not exempt from problems,
        including their high cost, the learning curve, and difficulty achieving a reliable record in
        certain circumstances, including edentulous full-arch records.
  
        Recordings of the edentulous full arch with IOSs pose a challenge due to the type of
        operation of these devices, which gradually collect and overlap information from small areas
        until completing a full arch. For this reason, different techniques have been proposed to
        improve the accuracy of this type of recording. In addition, if there is a case in which
        accuracy is crucial, it is complete edentulous arches with implants since, if the
        registration is not exact, the prosthesis manufactured on it will not have a passive fit in
        the mouth, which would lead to the appearance of both biological and mechanical
        complications.
  
        Different studies have tried to analyze how various factors influence this accuracy, and
        these factors can be divided into factors related to the operator, the scanner, environmental
        conditions, or intraoral conditions-also different scanning strategies or heights and
        positions of the scan bodies. However, most of these works have been developed in an in vitro
        environment. This fact is motivated by the greater ease of making the records and, as a more
        relevant fact, the possibility of obtaining a reliable reference model, employing a
        coordinate machine (Coordinate Measurement Machine (CMM)) or a desktop scanner, something
        that in an in vivo study it is not possible.
  
        The present study aims to clinically analyze the accuracy of different intraoral scanning
        strategies and types of scan bodies in edentulous full arch registrations on implants.
  
        JUSTIFICATION Due to the importance of the accuracy in taking digital impressions in
        full-arch patients for the fabrication of restorations on implants, it is considered
        justified to study the influence of different scanning strategies and scan bodies on the
        accuracy of full-arch recording.
  
        VIABILITY The project could be considered viable by having all the instruments and apparatus
        necessary to develop the material and methods. It is estimated that the proposed methodology
        could be developed within the period described.
  
        AIM The purpose of this in vivo study will be to measure the influence of different scanning
        strategies (zigzag with conventional scan body, circumferential with conventional scan body,
        surface blocking with conventional scan body, zigzag with low profile scan body, standard
        strategy with low profile scan body) on the accuracy of the records obtained for a case of
        fixed rehabilitation on full-arch dental implants.
  
        HYPOTHESIS The null hypothesis will be that there are no significant differences in scanning
        accuracy (trueness and precision) between the different groups of digital impressions
        compared to the reference model (conventional impression with rigid splinting).
  
        The alternative hypothesis will be that there are significant differences in scanning
        accuracy (trueness and precision) between the different groups of digital impressions
        compared to the reference model (conventional impression with rigid splinting).
  
        MATERIAL AND METHOD A patient will be selected who is susceptible to rehabilitation with a
        fixed prosthesis on implants, in good general health (ASA I and ASA II), without joint
        problems or limitation of opening, and who, after reading the information sheet, the patient
        and informed consent, and clarified any doubts, voluntarily agree to participate in the
        study.
  
        A reference model will be taken with a high-precision conventional methodology such as Rigid
        Impression Splinting. A first impression will be taken with double-mix addition silicone
        (putty and fluid) with an open tray. From this record, a first model will be generated that
        will be used to splint the impression transfers with a rigid, low-shrinkage light-curing
        material, which will later be sectioned with discs. Subsequently, the transfers will be
        screwed with the splint in the mouth and rejoined using a low-shrinkage light-curing
        material, thus minimizing the possibility of accumulation of errors. A second impression will
        be taken dragging the entire set, and it will be cast in improved type IV plaster (GC
        Fujirock; GC), thus obtaining the master model. This model will be digitized using a
        laboratory scanner to get the reference digital model, against which the specimens resulting
        from the experimental groups will be compared.
  
        Six experimental groups will be created based on the strategy-scan body used (1.- zigzag with
        conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.-
        surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body
        (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with
        low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the
        patient's mouth, to be compared with the reference model, called the "master model".
  
        Based on previous studies, a sample size of n=15 is estimated for each group. A pilot study
        will be carried out with n=5, from which a statistical test (G* Power; University of
        Düsseldorf) will be carried out to calculate the sample size. All digitization procedures
        will be performed under lighting conditions of 1000 lux measured with a lux meter (LX1330B
        Light Meter; Dr. Meter Digital Illuminance) and at a constant temperature of 24 +/-2 ºC. Once
        the files are obtained, they will be exported with the reference format for a
        3-dimensional.STL (standard tessellation language) file to a metrology program (Geomagic
        Control X). The results will be compared with a reference file, and the deviations of the
        implant positions will be obtained using the best-fit algorithm. The mean square error (Root
        Mean Square) will be calculated.
  
        statistical plan Statistical tests will be developed to check the normal distribution of the
        samples, Shapiro-Wilk or Kolmogorov-Smirnov type. A priori tests will be carried out to
        verify the existence of statistically significant differences, and a posteriori for analyzing
        which groups such differences appear and their magnitude. Statistical power will be 95%, so
        those with p<.05 will be considered statistically significant differences. All statistical
        analysis will be performed using a statistical software program (IBM SPSS Statistics for
        Windows, v26; IBM Corp).
  
        VARIABLES COLLECTED AND DESCRIPTION OF THE ACTIONS TO BE CARRIED OUT AND FINAL DESTINATION OF
        THE SAMPLES The collected variable is the discrepancy in the position of the implants between
        the control model, reference, and the experimental groups, quantified as a Root Mean Square.
        The samples, in this case, files, will be saved anonymously on a hard drive, named so that
        the group to which they belong and the number of samples can be interpreted (Example:
        ZZ-SBL1). The scanning time and the number of frames will also be collected.
  
        SCHEDULE December 2022-March 2023: collection, sample preparation, development of
        experimental methodology, and data collection.
  
        April 2023-July 2023: Statistical analysis and writing of the manuscript.
  
        ETHICAL IMPLICATIONS To the best of the research team's knowledge, the most significant
        ethical implication lies in carrying out several recordings of the same patient. In this
        regard, it should be noted that, in addition to meeting the inclusion requirements, the
        participant wishes to participate completely voluntarily and know that the participant will
        not obtain any compensation, financial or in any other way. On the other hand, we must bear
        in mind that intraoral record-taking procedures with intraoral scanners can be considered
        harmless and painless, which simply means that the patient must keep his mouth open during
        the procedure.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Accuracy
  time frame: Up to 1 year
  description: Micrometers (root mean square deviations)
  measure: Number of photograms
  time frame: Up to 1 year
  description: Number of images
  measure: clinical scan time
  time frame: Up to 1 year
  description: Seconds (s)
  arm group label: scanning strategies
  arm group type: Experimental
  description: 6 experimental groups will be created based on the strategy-scan body used (1.- zigzag with conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.- surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the patient's mouth, to later be compared with the reference model, called the "master model".
  intervention type: Device
  intervention name: intraoral scan
  description: All the experimental groups will be developed with an intraoral scanner, a device that emits light and collects the image projected by that light, to build a 3-dimensional digital model. It is more comfortable than conventional impressions and it is a harmless, non-intrusive, and painless procedure.
  arm group label: scanning strategies
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Miguel Gómez-Polo, PhD, DDS
  role: Study Director
  affiliation: Universidad Complutense de Madrid
  last name: Miguel Gómez-Polo, PhD, DDS
  phone: +34 659390001
  email: mgomezpo@ucm.es
  last name: Miguel Gómez-Polo
  phone: +34 659390001
  email: mgomezpo@ucm.es
  facility: 
  status: Recruiting
  contact: 
  country: Spain
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  PMID: 37052054
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