<?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>IRCT2015031621494N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-17</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology of Babol University of Medical Sciences</primary_sponsor>
      <public_title>A histologic, histomorphometric and radiographic comparison between two complex of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral ridge augmentation: a preliminary study.</public_title>
      <acronym></acronym>
      <scientific_title>A histologic, histomorphometric and radiographic comparison between two complex of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral ridge augmentation: a preliminary study.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18831</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>4</phase>
      <hc_freetext>Lateral alveolar ridge augmentation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cenobone/ Cenomembrane.   &#13;
In this group, Cenobone granules with size of 150 to 1000 microns (Mineralized Cortico Cancellous powder) which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Cenomembrane with thickness of 0.2 to 0.6 microns which originates from allogenic pericardium, is placed over the graft materials. Both bone powder and absorbable membrane are products of Hamanandsaz Baft Kish, Iran. Intervention 2: Intervention group:Bio Oss/ Bio Gide.                 &#13;
In this group, Bio Oss granules with size of 500 to 1000 microns which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Bio Gide membrane with standard thickness which originates from pig collagen, is placed over the graft materials. Both bone powder and absorbable membrane are products of Geistlich Biomaterials (Bio Oss, Geistlich Pharma AG, Wolhusen, Switzerland).</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 Seyed Mohammad Ali Tabatabaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176- 47745</zip>
        <telephone>+98 11 3229 1408</telephone>
        <email>ma.tabatabaei@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Babak Amoeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176- 47745</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>amoian@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Subjects within the age range of 30 to 50 years, and with sufficient alveolar bone height who have alveolar ridge width of 2 to 4 mm in the area at a distance of 3 mm from the ridge crest are included in the study.&#13;
Exclusion criteria: Patients with certain systemic conditions which affect healing process are excluded from the survey, including: Uncontrolled diabetes; immune disorders; alcohol addiction; drug abuse; current smoking; pregnancy; immune suppressor or anticoagulant drugs consumption. Additionally, patients with poor compliance; sufferers from active periodontal diseases which complicate oral hygiene; and subjects who don't want to participate in the study are excluded.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k08.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atrophy of edentulous ridge</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: Cenobone/ Cenomembrane.   &#13;
In this group, Cenobone granules with size of 150 to 1000 microns (Mineralized Cortico Cancellous powder) which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Cenomembrane with thickness of 0.2 to 0.6 microns which originates from allogenic pericardium, is placed over the graft materials. Both bone powder and absorbable membrane are products of Hamanandsaz Baft Kish, Iran.</i_keyword>
      <i_keyword>Intervention group:Bio Oss/ Bio Gide.                 &#13;
In this group, Bio Oss granules with size of 500 to 1000 microns which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Bio Gide membrane with standard thickness which originates from pig collagen, is placed over the graft materials. Both bone powder and absorbable membrane are products of Geistlich Biomaterials (Bio Oss, Geistlich Pharma AG, Wolhusen, Switzerland).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lateral ridge augmentation. Timepoint: Six months following grafting. Method of measurement: Radiographic, histologic, and histomorphometric measures.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Trabecular thickness. Timepoint: Six months following grafting. Method of measurement: Histomorphometric evaluation six months following grafting.</sec_outcome>
      <sec_outcome>Number of blood vessels. Timepoint: Six months following grafting. Method of measurement: Evaluation in microscopic fields, six months following grafting.</sec_outcome>
      <sec_outcome>Extent of inflammation. Timepoint: Six months following grafting. Method of measurement: Evaluation in microscopic fields, six months following grafting.</sec_outcome>
      <sec_outcome>Foreign body reaction. Timepoint: Six months following grafting. Method of measurement: Evaluation in microscopic fields, six months following grafting.</sec_outcome>
      <sec_outcome>Bone vitality. Timepoint: Six months following grafting. Method of measurement: Evaluation in microscopic fields, six months following grafting.</sec_outcome>
      <sec_outcome>Biomaterial/bone contact. Timepoint: Six months following grafting. Method of measurement: Evaluation in microscopic fields, six months following grafting.</sec_outcome>
      <sec_outcome>Biomaterial/bone radiographic density. Timepoint: Six months following grafting. Method of measurement: CBCT examination, six months following grafting.</sec_outcome>
      <sec_outcome>Percentage of biomaterial remnants. Timepoint: Six months following grafting. Method of measurement: Histomorphometric evaluation six months following grafting.</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 and Technology of Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-07</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Ethics committee, Babol University of Medical Sciences, Ganj Afrooz St., Babol. Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
