<?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>IRCT20191204045602N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-27</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Platelet-Rich Fibrin versus Allogeneic Bone Grafts in stability of one stage implant placement</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between sinus augmentation with Platelet-Rich Fibrin versus Allogeneic Bone Grafts in stability of one stage implant placement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with sealed envelope and random allocation, Blinding description: The double-blind study is designed so that the examiners and statisticians are blind to the two study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Implant stability measurement.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients receive 2 grams of amoxicillin prophylactically one hour before surgery. After injection of Local anesthesia , a crystal incision is placed with an anterior releasing incision on both sides of the maxilla. The complete mucopestal flap is removed. Lateral should be created with complete safety and as much as possible without perforation of Schneiderin membranes. Then Schneiderin membrane lift will be performed on 2 sides.On the PRF side is the PRF plug. Then the implants with the same length and diameter (diameter 4.5 and length 12) from BIOTECH brand (kontact biotech dental implant, France with standard protocol according to the manufacturer's guideline with a speed of 800 rpm and a crack of 20 N will be installed on both sides. After surgery, the patient will be advised to use a cold compress at the surgical site and the antibiotic Ko Amoxiclav 375 mg in 20 pieces and gelofen analgesic and chlorhexidine mouthwash 0.12 % Will be prescribed for one week. Intervention 2: Control group:All patients receive 2 grams of amoxicillin prophylactically one hour before surgery. After injection of Local anesthesia, a crystal incision is made with an anterior releasing incision on both sides of the maxilla. The complete mucopestal flap is removed. The sinus lift in each patient is performed laterally on both sides using the TOLA SINUS KIT until the window. Lateral with complete safety and as much as possible without perforation of Schneiderin membranes, then Schneiderin membrane lift will be performed on 2 sides to strengthen the membrane on the opposite side of CENO BONE collagen membranes with a thickness of 0.2-0.6 mm with dimensions of 20 ˟ 20 mm .FDBA bone powder is placed with a particle size of 500-1000 µm, then the implants with the same length and diameter (diameter 4.5 and length 12) will be installed according to the standard protocol according to the manufacturer's guideline with a speed of 800 rpm and a crack of 20 N on both sides. The abutment will be closed on both sides, followed by a suture. After surgery, the patient will be advised to use a cold compress at the surgical site and will be prescribed the antibiotic Co Amoxiclav 375 mg in 20 pieces and gelofen analgesic and 0.12% chlorhexidine mouthwash for one week.</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:
Ability to share the main outcome

When:
Since 2022

To whom:
All people related to university centers

Conditions:
All people related to university centers

Where to obtain:
qazvin dental school maxillofacial department

How to obtain:
Must email the researcher to send the data as a file
aida_karagah@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>aida karagah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin, Bahonar Boulevard</address>
        <city>qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3323 9252</telephone>
        <email>Aida_karagah@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>aida karagah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin, Bahonar Boulevard</address>
        <city>qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419915315</zip>
        <telephone>+98 28 3323 5292</telephone>
        <email>Aida_karagah@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who need bilateral sinus augmentation
patients with adequate interocclusal and mesiodistal distance for implant placement
adequate width for implant placement
5 mm residual bone in each side</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>diabetic patients
patients with history of bone grafts
immunosupressive patients and corticosteroid users
patients with history of chemotherapy or radiotherapy</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>Intervention group:Patients receive 2 grams of amoxicillin prophylactically one hour before surgery. After injection of Local anesthesia , a crystal incision is placed with an anterior releasing incision on both sides of the maxilla. The complete mucopestal flap is removed. Lateral should be created with complete safety and as much as possible without perforation of Schneiderin membranes. Then Schneiderin membrane lift will be performed on 2 sides.On the PRF side is the PRF plug. Then the implants with the same length and diameter (diameter 4.5 and length 12) from BIOTECH brand (kontact biotech dental implant, France with standard protocol according to the manufacturer's guideline with a speed of 800 rpm and a crack of 20 N will be installed on both sides. After surgery, the patient will be advised to use a cold compress at the surgical site and the antibiotic Ko Amoxiclav 375 mg in 20 pieces and gelofen analgesic and chlorhexidine mouthwash 0.12 % Will be prescribed for one week.</i_keyword>
      <i_keyword>Control group:All patients receive 2 grams of amoxicillin prophylactically one hour before surgery. After injection of Local anesthesia, a crystal incision is made with an anterior releasing incision on both sides of the maxilla. The complete mucopestal flap is removed. The sinus lift in each patient is performed laterally on both sides using the TOLA SINUS KIT until the window. Lateral with complete safety and as much as possible without perforation of Schneiderin membranes, then Schneiderin membrane lift will be performed on 2 sides to strengthen the membrane on the opposite side of CENO BONE collagen membranes with a thickness of 0.2-0.6 mm with dimensions of 20 ˟ 20 mm .FDBA bone powder is placed with a particle size of 500-1000 µm, then the implants with the same length and diameter (diameter 4.5 and length 12) will be installed according to the standard protocol according to the manufacturer's guideline with a speed of 800 rpm and a crack of 20 N on both sides. The abutment will be closed on both sides, followed by a suture. After surgery, the patient will be advised to use a cold compress at the surgical site and will be prescribed the antibiotic Co Amoxiclav 375 mg in 20 pieces and gelofen analgesic and 0.12% chlorhexidine mouthwash for one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stability. Timepoint: Immediately after surgery and 2, 4 and 6 months later. Method of measurement: Stability: With ostell device, the degree of stability (ISQ) is measured based on resonance frequency analysis.</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>qazvin university if medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-23</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>qazvin,blvd bahonar qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
