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/NCT06011031</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU- Rec ID 210317</org_study_id>
      <nct_id>NCT06011031</nct_id>
    </id_info>
    <brief_title>Assessment of Novaloc and Locator Attachment Systems</brief_title>
    <official_title>Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the current study is to assess the effect of two types of attachments (Locator,&#xD;
        Novaloc) on the supporting structures both mechanically using stress strain analysis and&#xD;
        biologically through measuring bone height using cbct.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        14 Completely edentulous patients will be divided into two groups each group contains seven&#xD;
        patients: Group One: Each patient will be restored with 4 implant retained maxillary&#xD;
        overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.&#xD;
  &#xD;
        Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using&#xD;
        Nylon retention insert attachment system and Bone Level Ti implants.&#xD;
  &#xD;
        Bone height in millimeters will then be evaluated around each implant using cone beam&#xD;
        computed tomography at the time of placement of attachments, 6 months, 1 year&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 5, 2021</start_date>
    <completion_date type="Anticipated">December 5, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 5, 2023</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>This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>bone level change around implants</measure>
      <time_frame>Through study completion an average 1 year.</time_frame>
      <description>measurement of bone height mesial, distal to each implant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>Through study completion an average 1 year.</time_frame>
      <description>Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Completely Edentulous Maxilla</condition>
    <arm_group>
      <arm_group_label>Novaloc attachment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a newly developed device &quot;novaloc attachment system&quot;made of peek material and amorphous diamond like carbon.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>locator attachment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Novaloc attachment</intervention_name>
      <description>Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment</description>
      <arm_group_label>Novaloc attachment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Locator attachment</intervention_name>
      <description>Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment</description>
      <arm_group_label>locator attachment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Completely edentulous patient with u shaped dental arch.&#xD;
  &#xD;
            -  Systemically free.&#xD;
  &#xD;
            -  Patients completed all extraction at least 6 months before surgery.&#xD;
  &#xD;
            -  Patients Tempromandibular joint is free from any disease.&#xD;
  &#xD;
            -  Patient's mouth opening is proper for accessibility during surgery and implant&#xD;
               placement.&#xD;
  &#xD;
            -  Sufficient bone level (length, and width) at implant placement site.&#xD;
  &#xD;
            -  Presence of enough bone height at implant site close to the maxillary sinus.&#xD;
  &#xD;
            -  Absence of sinus pneumatization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Heavy smoker.&#xD;
  &#xD;
            -  Patients with bone diseases.&#xD;
  &#xD;
            -  Patients having a history of parafunctional habits.&#xD;
  &#xD;
            -  Patients with diabetes mellitus.&#xD;
  &#xD;
            -  Patients on chemotherapy or radiotherapy.&#xD;
  &#xD;
            -  Patients on any medications that reduce wound healing.&#xD;
  &#xD;
            -  Patients without sufficient bone level (height, width).&#xD;
  &#xD;
            -  Patients with sinus pneumatization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hany Ibrahim Eid, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Noha Helmy Nawwar, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed Mohamed Osama, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatma Fouad Sadek, AssistantLec</last_name>
      <role>Principal Investigator</role>
      <affiliation>Egyptian Russian University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Prosthodontics Department Faculty of Dentistry Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <zip>11591</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>implant overdenture</keyword>
    <keyword>maxilla</keyword>
    <keyword>novaloc</keyword>
    <keyword>locator</keyword>
    <keyword>peek</keyword>
    <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>Yes</sharing_ipd>
      <ipd_description>once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>1 year following publishing</ipd_time_frame>
      <ipd_access_criteria>researchers , students or post graduates</ipd_access_criteria>
    </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/NCT06011031
  org study id: FDASU- Rec ID 210317
  nct id: NCT06011031
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study is to assess the effect of two types of attachments (Locator,
        Novaloc) on the supporting structures both mechanically using stress strain analysis and
        biologically through measuring bone height using cbct.
  14 Completely edentulous patients will be divided into two groups each group contains seven
        patients: Group One: Each patient will be restored with 4 implant retained maxillary
        overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.
  
        Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using
        Nylon retention insert attachment system and Bone Level Ti implants.
  
        Bone height in millimeters will then be evaluated around each implant using cone beam
        computed tomography at the time of placement of attachments, 6 months, 1 year
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups
  measure: bone level change around implants
  time frame: Through study completion an average 1 year.
  description: measurement of bone height mesial, distal to each implant
  measure: patient satisfaction
  time frame: Through study completion an average 1 year.
  description: Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.
  arm group label: Novaloc attachment
  arm group type: Experimental
  description: a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.
  arm group label: locator attachment
  arm group type: Active Comparator
  description: a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees
  intervention type: Device
  intervention name: Novaloc attachment
  description: Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
  arm group label: Novaloc attachment
  intervention type: Device
  intervention name: Locator attachment
  description: Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
  arm group label: locator attachment
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hany Ibrahim Eid, Prof
  role: Study Director
  affiliation: Ain Shams University
  last name: Noha Helmy Nawwar, Prof
  role: Study Director
  affiliation: Ain Shams University
  last name: Ahmed Mohamed Osama, Prof
  role: Study Director
  affiliation: Ain Shams University
  last name: Fatma Fouad Sadek, AssistantLec
  role: Principal Investigator
  affiliation: Egyptian Russian University
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Mouth, Edentulous
  sharing ipd: Yes
  ipd description: once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 1 year following publishing
  ipd access criteria: researchers , students or post graduates