<?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>IRCT20200125046247N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-15</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the use of collagen membranes in comparison with non-use of membranes in sinus floor surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the use of collagen membranes on the osteotomy window in the open sinus lift approach.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is based on random number table.
Randomization type: Simple randomization.This method uses simple randomization models such as tap or line, use of random numbers table or computer randomization methods, and each client for example with throws coin, tap and line,put it in the intervention or control group or It is very simple to implement, Blinding description: This is a double blind study.
Statistical analyst and pathologist evaluator were blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Study on Maxillary Sinus Lift Surgery..</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group:" No collagen membrane use over the bone window in open sinus lift surgery.                                                                                                at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place                                                           and Without covering the bone window by the membrane, the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture. Intervention 2: "Control group:" Use of absorbed collagen membrane with a diameter of 0.2–0.4 mm over the bone window in open sinus lift surgery.                                                                      at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place.the bone window was covered with collagen membrane, then the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I am currently a student, I do not think of anything else other than the thesis,After the thesis i will decide to publish this article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Jabbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 54-14th gooya,gooya street,malekabad blv</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9186654773</zip>
        <telephone>+98 51 3602 7437</telephone>
        <email>negin.jb73@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Mojgan Kazemian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry,opposite Mellat Park, Vakilabad Boulevard,Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٩۴٨٩۵٩</zip>
        <telephone>+98 915 515 7022</telephone>
        <email>kazemianmz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The remaining bone height is 3 to 5 mm.
Good oral hygiene.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Radiotherapy in the head and neck area.
Uncontrolled diabetes.
Pregnancy.
Pathological lesion or sinus disease.
Uncontrolled periodontal disease.
History of chemotherapy in the last 12 months before surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XXI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Factors influencing health status and contact with health services</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group:" No collagen membrane use over the bone window in open sinus lift surgery.                                                                                                at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place                                                           and Without covering the bone window by the membrane, the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture.</i_keyword>
      <i_keyword>"Control group:" Use of absorbed collagen membrane with a diameter of 0.2–0.4 mm over the bone window in open sinus lift surgery.                                                                      at first the crestal incision was made in the maxillary posterior tooth and lateral sinus wall and two mesial and distal liberator incisions were made for better access, and then the mucopriosteal flap was raised as full-thickness for lateral sinus wall exposure from the bone. Then the bone window was created according to the dimensions of the area. After exposure of the Schneiderin membrane, using sinus membrane brushes, the sinus membrane was separated from the bone and the bone window was directed upward. Then, coarse-grained allografts of size 1000–2000.(Mineralized and Demineralized Blend) was Compressed in Place.the bone window was covered with collagen membrane, then the mucoperiosteal flap was placed over the area and finally sutured with a 3-0 suture.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of newly formed bone in patients undergoing sinus lift surgery. Timepoint: Measurement of newly formed bone is performed 6 months after sinus lift surgery and at implant placement time. Method of measurement: The amount of newly formed bone in each slide was calculated by the image j software. It gives a number that specifies the surface area of ​​each slide. Finally, the number obtained for each patient that represents the amount of newly formed bone is entered into the Statistical Package for Social Sciences(spss)software.</prim_outcome>
      <prim_outcome>The amount of connective tissue in patients undergoing sinus lift surgery. Timepoint: Measurement of connective tissue is performed 6 months after sinus lift surgery and at implant placement time. Method of measurement: The amount of connective tissue in each slide was calculated by image j software. It gives us a number that specifies the ​​surface area of each slide. Finally, the numbers obtained for each patient indicating the amount of connective tissue are entered into the Statistical Package for Social Sciences(spss) software.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-19</approval_date>
        <contact_name>Mashhad Dental School Ethics Committee</contact_name>
        <contact_address>Faculty of Dentistry,opposite mellat park,vakilabad blv,mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
