<?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>IRCT138903164106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-10-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Babol University of Medical Sciences</primary_sponsor>
      <public_title>Histologic and Histomorphometric Evaluation of  Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation</public_title>
      <acronym></acronym>
      <scientific_title>Histologic and Histomorphometric Evaluation of  Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Histologic and histomorphometric analysis of horizontal alveolar ridge augmentation.</hc_freetext>
      <i_freetext>After reflection of a full-thickness flap for gaining access to the buccal bone of edentulous ridge, Natix biomaterial is mixed with blood and saline and then placed on the area of bone defect. Then the augmneted area will be covered by Cytoplast resorbable membrane. Without any tension the flaps are tied together. 8 month after surgery, full thickness flaps are reflected for the purpose of implant surgery. Biopsy specimens in shape of a bone core are harvested from the area of implant insertion. Specimens are sended to laboratory for histologic and histomorphometric study..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Javad Mehrani Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Depatment of Periodontics, Faculty of dentistry,  Medical Uneversity, Ganjafrooz avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1222 4032</telephone>
        <email>j.mehrani@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences, Faculty of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Javad Mehrani Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Depatment of Periodontics, Faculty of dentistry,  Medical Uneversity, Ganjafrooz avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1222 4032</telephone>
        <email>j.mehrani@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- Patients ranging from 30 to 50 years old 2- Patients demanding implant treatment in posterior regions of mandibular alveolar ridge 3- Sufficient vertical height of bone in posterior mandibular region with inadequate buccolingual width (width of less than 5 mm and minimum width of 2 mm) 4- Healthy patients 5- Minimum of one augmentation site for each patient requiring implant treatment.   Exclusion criteria: 1- Patients having systemic conditions affecting healing such as: Uncontrolled Diabetes, Immune diseases, Systemic or local diseases of bone, history of Alcoholism, Patients taking Immunosuppressive or Anticoagulant medications 2- poor compliance 3- Patients having untreated active periodontal disease 4- Patients unable to maintain oral health status or not interested in maintaining oral health status.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of teeth and supporting structures</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After reflection of a full-thickness flap for gaining access to the buccal bone of edentulous ridge, Natix biomaterial is mixed with blood and saline and then placed on the area of bone defect. Then the augmneted area will be covered by Cytoplast resorbable membrane. Without any tension the flaps are tied together. 8 month after surgery, full thickness flaps are reflected for the purpose of implant surgery. Biopsy specimens in shape of a bone core are harvested from the area of implant insertion. Specimens are sended to laboratory for histologic and histomorphometric study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Histologic and Histomorphometric Evaluation of effect of Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation. Timepoint: 8 months after intervention. Method of measurement: Biopsy specimens are taken from the augmented site by Natix, and are stained with Hematoxilin &amp; Eosin and parameters such as: 1-amount of inflammation 2-existence or inexistence of foreign body reaction (giant cells and granulomatous reactions) 3-Bone vitality (Existence or inexistence of osteocytes in lacunaes) 4-Thickness of bone trabecules 5-Way of contact between bone-biomaterial (existence or inexistence of connective tissue between bone fragments) are analysed.</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>Vice chancellor for research, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>Periodontic Department, Faculty of Dentistry, Medical University, Ganjafrooz Avenue Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
