<?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>IRCT20180630040290N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-03</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of concentrated serum on histological and clinical characteristics of dental tissue</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Autologous concentrated serum on the histological and clinical characteristics of soft tissue after Horizontal Bone Augmentation and Socket Preservation surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random sampling method is available among people referring to the periodontics department of Tabriz Dental School. The method of randomization is simple and its unit is individual. Our tool is to randomize the table of random numbers. Also, treatment was assigned to patients randomly.
The type of treatment was identified by code A (intervention) and B (control) and placed inside sealed envelopes; The envelopes were then placed in a bag and shaken. Then, it was accidentally taken out of the bag, and after observing the code, the treatment was given to the patient. The evaluator was not aware of the type of treatment, Blinding description: The present study is one-way blind and the evaluator will also be is not informed about the type of treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Horizontal alveolar bone loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in need of horizontal ridge reconstruction surgery and silent protection on both sides of the ridge are selected and placed for implant placement. An ACS-impregnated collagen membrane is then applied to one side.During the first week after surgery, the clinical features of soft tissue such as pain in the area with Visual analogue scale (VAS) and other clinical symptoms such as swelling, redness, sensation of the wound, etc. are evaluated with REEDA index and report results. Becomes.Also, 4 months after surgery during implant surgery, a piece of soft tissue is punched at the implant site and sent to the laboratory to examine the histological characteristics of the soft tissue. Intervention 2: Control group: Patients in need of horizontal ridge reconstruction surgery and silent protection on both sides of the ridge are selected and placed for implant placement. On the opposite side, only the collagen membrane is used.During the first week after surgery, the clinical features of soft tissue such as pain in the area with Visual analogue scale (VAS) and other clinical symptoms such as swelling, redness, sensation of the wound, etc. are evaluated with REEDA index and report results. Becomes.Also, 4 months after surgery during implant surgery, a piece of soft tissue is punched at the implant site and sent to the laboratory to examine the histological characteristics of the soft tissue.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir reza Babaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>amirezababaloo@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The amount of bone needed for reconstruction is the same on both sides.
Candidate patients extract teeth on both sides of the jaw
Partial edentulous patients on both sides of the jaw</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>smokers
Pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K06.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Horizontal alveolar bone loss</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in need of horizontal ridge reconstruction surgery and silent protection on both sides of the ridge are selected and placed for implant placement. An ACS-impregnated collagen membrane is then applied to one side.During the first week after surgery, the clinical features of soft tissue such as pain in the area with Visual analogue scale (VAS) and other clinical symptoms such as swelling, redness, sensation of the wound, etc. are evaluated with REEDA index and report results. Becomes.Also, 4 months after surgery during implant surgery, a piece of soft tissue is punched at the implant site and sent to the laboratory to examine the histological characteristics of the soft tissue.</i_keyword>
      <i_keyword>Control group: Patients in need of horizontal ridge reconstruction surgery and silent protection on both sides of the ridge are selected and placed for implant placement. On the opposite side, only the collagen membrane is used.During the first week after surgery, the clinical features of soft tissue such as pain in the area with Visual analogue scale (VAS) and other clinical symptoms such as swelling, redness, sensation of the wound, etc. are evaluated with REEDA index and report results. Becomes.Also, 4 months after surgery during implant surgery, a piece of soft tissue is punched at the implant site and sent to the laboratory to examine the histological characteristics of the soft tissue.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain measurement. Timepoint: During a week. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Clinical symptoms. Timepoint: During a week. Method of measurement: REEDA (Redness, edema, ecchymosis, discharge from the wound, approximation).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Histological features. Timepoint: 4 months later. Method of measurement: Pathology laboratory.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-12</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
