<?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>IRCT20210204050239N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in dental implants</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial to investigate the effect of the remaining bony walls of the maxillary sinus on the quality of the formed bone in single maxillary posterior teeth implants, compared to multiple maxillary posterior teeth implants after sinus lift</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients whose undergoing dental implants treatment and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.</study_design>
      <phase>2</phase>
      <hc_freetext>Teeth implants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group I will receive sinus lift surgery for single posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 5 bony walls (medial, lateral, mesial, distal, and inferior). Intervention 2: Intervention group: Intervention group II will receive sinus lift surgery for multiple posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 3 bony walls (medial, lateral, and inferior).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information on the main outcome or the like can be shared.

When:
6 months after printing results

To whom:
Our data will only be available to researchers working at science centers and universities.

Conditions:
Our data will be available for scholars working at science centers and universities.

Where to obtain:
Mehran Farhadi the data analysis to the applicants via email: Mehran.farhaadi74@gmail.com

How to obtain:
Applicants can respond to the email of the respondent and receive a response within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehran Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3883 2300</telephone>
        <email>Mehran.farhaadi74@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehran Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3883 2300</telephone>
        <email>Mehran.farhaadi74@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged range of 20-50 years
Patients candidate for maxillary posterior teeth implants with a minimum of 2-4 mm alveolar bone thickness according to CBCT with a need for the sinus lift</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of systemic diseases
Patients who cannot undergo routine oral surgery
Patients who smoke more than 10 cigarettes daily
The presence of sinusitis
Pregnant and breastfeeding women
History of allergies
Membrane perforations more than 2 mm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of other specified functional implants</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: Intervention group I will receive sinus lift surgery for single posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 5 bony walls (medial, lateral, mesial, distal, and inferior).</i_keyword>
      <i_keyword>Intervention group: Intervention group II will receive sinus lift surgery for multiple posterior maxillary implants with a residual alveolar bone thickness of 2-4 mm and 3 bony walls (medial, lateral, and inferior).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The bone mineral density formed. Timepoint: 6 months after the intervention. Method of measurement: Cone beam computed tomography.</prim_outcome>
      <prim_outcome>The rate of angiogenesis. Timepoint: 6 months after the intervention. Method of measurement: Histological osteogenesis with hematoxylin-eosin staining.</prim_outcome>
      <prim_outcome>Number of osteoblasts per unit area. Timepoint: 6 months after the intervention. Method of measurement: Histological osteogenesis with hematoxylin-eosin staining.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Implant stability in the bone graft. Timepoint: Immediately and 4 months after the intervention. Method of measurement: Osstell Mentor.</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>2019-10-02</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
