<?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>IRCT20230714058773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-02</date_registration>
      <primary_sponsor>Armed forces institute of dentistry CMH Rawalpindi</primary_sponsor>
      <public_title>Comparison of Soft Tissue Healing in Immediate Implant Placement in Fresh Extraction Socket with and without the Use of Platelet-Rich Fibrin</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Soft Tissue Healing in Immediate Implant Placement in Fresh Extraction Socket with and without the Use of Platelet-Rich Fibrin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72340</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Implant Placement, Extraction Socket, Platelet-Rich Fibrin.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume  bone height and width, good oral hygiene, immediate implant placement was done after extraction with the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score. Intervention 2: Control group: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume  bone height and width, good oral hygiene, immediate implant placement was done after extraction without the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam@hotmail.com</email>
        <affiliation>Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>tehminamaryam@hotmail.com</email>
        <affiliation>Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of maxillary or mandibular tooth
Tooth indicated for extraction without any active infection
Presence of adequate and harmonious gingival architecture with the surrounding dentition
Adequate bone volume  bone height and width
Good oral hygiene</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Edentulous Patients .	.
Patients on chemotherapy
Patients on radiotherapy
Systemic diseases such as diabetes
Habit of Smoking
Any active infection surrounding tooth indicated for extraction
Poor oral hygiene</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of tooth-root and mandibular implants</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: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume  bone height and width, good oral hygiene, immediate implant placement was done after extraction with the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score.</i_keyword>
      <i_keyword>Control group: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume  bone height and width, good oral hygiene, immediate implant placement was done after extraction without the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cover screw exposure. Timepoint: 0 and 7th post op day. Method of measurement: Will be measured as frequency and percentage. Chi-Square test will be applied to compare qualitative variable like Cover screw exposure on 7th post op day between two groups.</prim_outcome>
      <prim_outcome>Pink esthetic score. Timepoint: 3rd and 6th month after intervention. Method of measurement: Will be measured as frequency and percentage. Chi-Square test will be applied to compare qualitative variable like Pink esthetic score after 3 and 6 months follow up between two groups.</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>Armed forces institute of dentistry CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-19</approval_date>
        <contact_name>Ethics committee of armed forces institute of dentistry CMH Rawalpindi</contact_name>
        <contact_address>Range road Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
