<?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>IRCT20170419033535N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Freeze-Dried Bone Allograft on new bone formation after tooth extraction</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Healing Time on New Bone Formation after Tooth Extraction with Freeze-Dried Bone Allograft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Dividing the samples completely randomly into two groups of 3 months (Intervention group) and 4 months (Control group) by dropping the coin and hiding the card until the patients were recalled, Blinding description: All individuals involved in this research, such as Clinicians, Outcome Evaluators, Data Analyzers, Safety Committees, and Data Monitoring, have been unaware of the randomization process of samples, and only researchers and therapists in this study have compared the time Sampling and referral of patients are well known.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Evaluation of bone formation with FDBA after tooth extraction..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group includes 20 dental samples need to be extracted and required Implant treatment. The dental socket (after  tooth extraction) is filled with FDBA, from Hamanand Saz Baft Kish company, Iran, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (3 months) and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is  delivered to the Pathology Laboratory. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material. Intervention 2: Control group: This group includes 20 dental samples need to be extracted and required implant treatment. The dental socket (after  tooth extraction) is filled with FDBA, from Hamanand Saz Baft Kish company, Iran, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (4 months) , and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is  delivered to the Pathology Laboratory. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material.</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:
Comparison of short-term effects (3 months, intervention group) and long-term effects (4 months, control group)  of FDBA application on Histopathology of bone formation following tooth extraction in patients referring to dental unit of Islamic Azad University of Tehran in 1396-1397.

When:
6 months after printing results

To whom:
All people who need data can apply for them.

Conditions:
Analyzes that do not harm our data.

Where to obtain:
Faculty of Dentistry Islamic Azad University of Tehran

How to obtain:
Visit the Faculty of Dentistry, Islamic Azad University of Tehran and  request there, and will access the data within 1 week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omid Moghadas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ninth Neyestan  Avenue, Pasdaran Street, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>o_moghaddas@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Omid Moghadas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ninth Neyestan  Avenue, Pasdaran Street, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>o_moghaddas@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single-rooted teeth needing extraction
Patient desiring restoration with Dental implant
Adequate space for Restoration</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients not fulfilling inclusion criteria or not compliant with necessary procedural follow-up
Active Systemic/Local infection not including Periodontitis
Medical conditions or medications known to alter soft tissue or bony healing (Poorly controlled Diabetes Mellitus [DM], Bisphosphonates, Immunosuppressives, etc.)
Teeth with short roots or roots that were Malpositioned such that the Core Biopsy might include bone along the Socket Wall. Females of childbearing age without Tubal Ligation, Menopause, or Hysterectomy were required to have a Negative Pregnancy Test prior to Surgery.
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atrophy of edentulous alveolar 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: This group includes 20 dental samples need to be extracted and required Implant treatment. The dental socket (after  tooth extraction) is filled with FDBA, from Hamanand Saz Baft Kish company, Iran, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (3 months) and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is  delivered to the Pathology Laboratory. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material.</i_keyword>
      <i_keyword>Control group: This group includes 20 dental samples need to be extracted and required implant treatment. The dental socket (after  tooth extraction) is filled with FDBA, from Hamanand Saz Baft Kish company, Iran, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (4 months) , and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is  delivered to the Pathology Laboratory. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of Bone Formation. Timepoint: 3 months and 4 months. Method of measurement: Calculated by Optical Microscope.</prim_outcome>
      <prim_outcome>The amount of Residual Graft. Timepoint: 3 months and 4 months. Method of measurement: Calculated by Optical Microscope.</prim_outcome>
      <prim_outcome>The amount of Connective Tissue and Inflammation Rate. Timepoint: 3 months and 4 months. Method of measurement: Calculated by Optical Microscope.</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>2017-06-18</approval_date>
        <contact_name>Faculty of Dentistry Islamic Azad University of Tehran</contact_name>
        <contact_address>Ninth Neyestan  Avenue, Pasdaran Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
