<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200825048522N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of immediate and delayed implantation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Immediate and Delayed Implantation on Insertion Torque and Primary Stability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50524</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Treatment of edentulous with implant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The site to receive the implant immediately. After the atroumatic extraction of the tooth and then the full thickness flaps will be prepared under local anesthesia and the osteotomy areas will be prepared according to the manufacturer&amp;#39;s instructions. Exploratory examination of the socket after extraction will be performed by the probe to identify defects - especially in the buccal wall - which in this study are considered immediate contraindications. According to the existing protocol for one-step surgery, two implants will be placed in each patient by a calibrated torque wrench for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again. Intervention 2: Control group: On the edentulous side, full-thickness flaps will then be provided under local anesthesia, and osteotomy areas will be prepared according to the manufacturer's instructions. A scale will be placed for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values ​​calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Seifollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.58, Jafary alley, Afshary Ave., Pasadaran, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666833138</zip>
        <telephone>+98 21 2277 6996</telephone>
        <email>seifollahisahar1375@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Seifollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.58, Jafary alley, Afshary Ave., Pasadaran, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666833138</zip>
        <telephone>+98 21 2277 6996</telephone>
        <email>seifollahisahar1375@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy systemic conditions
Have at least one hopeless tooth to extract
An edentulous area with similar position in jaw and  bone density to area with hopeless tooth</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heavy smoker
Uncontrolled diabetes
Ridge augmentation necessity
Long term use of NASIDs
Lake of space from opposite jaw that cannot use implant
Oral or intravenous use of Bisphosphonate
Untreatment periodental disease
Malocclusion
Severe cavities
Periapical lesions
Unacceptable occlusion because of over eruption or tilt of teeth to edentulous area</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The site to receive the implant immediately. After the atroumatic extraction of the tooth and then the full thickness flaps will be prepared under local anesthesia and the osteotomy areas will be prepared according to the manufacturer&amp;#39;s instructions. Exploratory examination of the socket after extraction will be performed by the probe to identify defects - especially in the buccal wall - which in this study are considered immediate contraindications. According to the existing protocol for one-step surgery, two implants will be placed in each patient by a calibrated torque wrench for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again.</i_keyword>
      <i_keyword>Control group: On the edentulous side, full-thickness flaps will then be provided under local anesthesia, and osteotomy areas will be prepared according to the manufacturer's instructions. A scale will be placed for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values ​​calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measure of primary stability of immediate implantation. Timepoint: Immediatly after insertion of implant. Method of measurement: Using Osstell and numbered torque wrench.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-23</approval_date>
        <contact_name>Iran national committe for ethics in biomedical research</contact_name>
        <contact_address>NO.58, Jafary alley, Afshary Ave., Pasadaran, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
