<?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>IRCT20221228056958N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-03</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of platelet rich fibrin on soft tissue quality after immediate implant placement</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of platelet-rich fibrin (L-PRF) plug on the level of alveolar crest keratinized gingiva in immediate implant placement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: randomization will be block (blocks of 4) and individually
Randomization tool: random allocation software 2
Using the software, codes A and B will be generated, where code A means applying the intervention group and code B means applying the control group for each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. After the arrival of each patient, the doctor will open the envelope and apply the intended treatment, Blinding description: In this study, the researcher is unaware of the type of treatment performed on the patient, and this information is kept with the surgeon.</study_design>
      <phase>3</phase>
      <hc_freetext>Lack of keratinized gingiva around the implant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the crest or at most 0.5 mm below the corset (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). After placing the implant, it will be placed on it as a platelet and leukocyte-rich fibrin plug (L-PRF). The surgeon will administer platelet and leukocyte-rich fibrin (L-PRF). Intervention 2: Control group: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the corset or at most 0.5 mm below the crest (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). In the first group, after placing the implant, an additional step will not be performed, and the flap will be displaced coronally just to avoid exposing the implant.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Najme Sadat Valed Saravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>mazandaran university of medical scienses, jooybar 3 ways, sari</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>n.valed@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Najme Sadat Valed Saravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>mazandaran university of medical scienses, jooybar 3 ways, sari</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>n.valed@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with systemic health (class 1 according to the ASA classification)
cooperative
good oral hygiene and absence of acute infection
Patients with teeth indicated for extraction due to terminal periodontal disease, root fracture, or root resorption
Patients who were willing to visit again.
Patients should not have untreated periodontal disease.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with compromised systemic conditions (ASA 2,3,4,5,6)
inadequate oral hygiene and presence of acute infection
Patients without teeth indicated for extraction or unwilling for implant treatment
Patients unwilling to visit again
Patients with untreated periodontal disease
Uncooperative</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: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the crest or at most 0.5 mm below the corset (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). After placing the implant, it will be placed on it as a platelet and leukocyte-rich fibrin plug (L-PRF). The surgeon will administer platelet and leukocyte-rich fibrin (L-PRF).</i_keyword>
      <i_keyword>Control group: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the corset or at most 0.5 mm below the crest (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). In the first group, after placing the implant, an additional step will not be performed, and the flap will be displaced coronally just to avoid exposing the implant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Keratinized gingiva width. Timepoint: Before tooth extraction, 2 weeks after healing abutment placement. Method of measurement: Using a periodontal probe and the Rolling technique.</prim_outcome>
      <prim_outcome>Keratinized gingiva thichness. Timepoint: Before tooth extraction, 2 weeks after healing abutment placement. Method of measurement: Using a Williams periodontal probe that goes into the tissue until it reaches the bone.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-11</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Sari, Jouybar three ways, Mazandaran University of Medical Sciences sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
