<?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>IRCT20101204005305N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two methods using mineralized allogeneic bone graft with or without iPRF in the reconstruction of horizontal alveolar ridge defects.</public_title>
      <acronym></acronym>
      <scientific_title>Histomorphometrical and radiological comparison of  mineralized allogeneic bone graft with or without L-PRF in the reconstruction of horizontal alveolar ridge defects in a randomized controlled clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57707</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done with the minimization method. Randomization of 10 to 20 percent of the samples will be done in a simple way by tossing a coin, and then the participants will be divided into two intervention groups and control groups based on their gender in order to homogenize the groups, Blinding description: Two clinicians who are calibrated and blind to the study will perform all radiographic measurements. The demographic data of all radiographies will be removed and a code will be given to each radiography. A pathologist who is blind to the study will assess the prepared slides. For blindness, a code will be given to each slides.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Edentulous ridge  width.</hc_freetext>
      <i_freetext>Intervention 1: Control group: First a mid-crystal incision is made and then vertical release incisions with a gap tooth on each side to increase access. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used. The bone marrow is moistened with sterile saline solution before use. After placement of the target area, it is completely covered by absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish tissue replicator, Kish, Iran). The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. Soft tissue closure is initially done with Supa, Iran (Supalon, 5-0) nylon sutures with 3 techniques: Horizontal mattress, interrupted and crisscross. 6 months after the agglomeration process, the implants are placed during the second surgery. Intervention 2: Intervention group: First, blood is taken from the patient's cephalic vein and centrifugation is performed on it to inject platelet rich fibrin. Then, in the operation stage, a mid-crystal incision is made and then the vertical releasing incisions are struck with a gap tooth on each side to increase. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used with iPRF. The affected bone is moistened with sterile saline solution before use. After placing the desired area, it is completely covered by an absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish, Kish, Iran) tissue replicator. The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. The closure of the soft tissue is initially done with Supalon, Iran (Supalon 5-0) nylon sutures and with 3 horizontal mattress techniques, cut and crossed. 6 months after the agglomeration process, the implants are placed during the second operation.</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:
Part of the data is shared after the people are made unrecognizable.

When:
2023-2024

To whom:
Academic persons

Conditions:
No special access criteria

Where to obtain:
E-mail:mmohammadi28@yhoo.com

How to obtain:
There are not details

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street, Dental School</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>mmohammadi28@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>mmohammadi28@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>need to horizontal augmentation of alvolar bone for implant treatment (edentulous ridge width: 2/5 - 4 mm )</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of more than 10 cigarettes per day
Pregnancy
Uncontrolled periodontal disease
Use of bisphosphonate and corticosteroid
Chemotherapy and radiotherapy
Systematic diseases for example: non controlled diabetes; osteoporosis and immune deficiency</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Control group: First a mid-crystal incision is made and then vertical release incisions with a gap tooth on each side to increase access. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used. The bone marrow is moistened with sterile saline solution before use. After placement of the target area, it is completely covered by absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish tissue replicator, Kish, Iran). The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. Soft tissue closure is initially done with Supa, Iran (Supalon, 5-0) nylon sutures with 3 techniques: Horizontal mattress, interrupted and crisscross. 6 months after the agglomeration process, the implants are placed during the second surgery.</i_keyword>
      <i_keyword>Intervention group: First, blood is taken from the patient's cephalic vein and centrifugation is performed on it to inject platelet rich fibrin. Then, in the operation stage, a mid-crystal incision is made and then the vertical releasing incisions are struck with a gap tooth on each side to increase. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used with iPRF. The affected bone is moistened with sterile saline solution before use. After placing the desired area, it is completely covered by an absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish, Kish, Iran) tissue replicator. The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. The closure of the soft tissue is initially done with Supalon, Iran (Supalon 5-0) nylon sutures and with 3 horizontal mattress techniques, cut and crossed. 6 months after the agglomeration process, the implants are placed during the second operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Horizontal edentulous ridge width. Timepoint: Measurement of edentulous ridge width by CT scan of the patient at the beginning of the study and 6 months after reconstructive surgery. Method of measurement: Bone width measurement from CBCT radiograph.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-06</approval_date>
        <contact_name>Ethics committee of Kerman university of medical science</contact_name>
        <contact_address>Tahmasebabad crossroads, researches center Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
