<?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>IRCT20230926059527N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-30</date_registration>
      <primary_sponsor>AFID</primary_sponsor>
      <public_title>Maxillary Sinus Lifting: A Comparison Of Success Rate of Direct Versus Indirect Sinus Lifting for Vertical Bone Augmentation in Patients Receiving Dental Implants</public_title>
      <acronym></acronym>
      <scientific_title>Maxillary Sinus Lifting: A Comparison Of Success Rate of Direct Versus Indirect Sinus Lifting for Vertical Bone Augmentation in Patients Receiving Dental Implants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was performed by using lottery method(Lottery chits with even and odd numbers were used. Patients with even number chits were placed in one group and with odd number chits in the second group).Allocation concealment was done using folded chits. Patients in first group got sinus lifting done by Direct Method and in second group Indirect Sinus lifting was performed, Blinding description: Patients were blinded as they were not informed about the treatment modality used for management of their ailment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Missing tooth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Direct Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After Caldwellluc incision the bony window will be created. After lifting the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures. Intervention 2: Intervention group 2: Indirect Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After extraction of the tooth the same socket will be used to lift the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures.</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>Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi Near Lalkurti</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ammar Yasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AFID, CMH Rawalpindi Near Lalkurti</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 346 7330822</telephone>
        <email>seirraalphayankee@gmail.com</email>
        <affiliation>Armed Forces Institute of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having physical status 1 according to ASA classification
HaviBone Height Less than 5mm in Maxillary Molar Region</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women, nursing mothers &amp; smokers
Patient with infection in Maxillary Molar Region
Patients Having Sinus Pathology
Patient with medications that can alter pain perception</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complete loss of teeth</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 1: Direct Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After Caldwellluc incision the bony window will be created. After lifting the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures</i_keyword>
      <i_keyword>Intervention group 2: Indirect Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After extraction of the tooth the same socket will be used to lift the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post Op Pain. Timepoint: 3rd and 5th Day after Intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Gingival inflammation. Timepoint: 3rd and 5th Day after Intervention. Method of measurement: Gingival Index.</prim_outcome>
      <prim_outcome>Swelling. Timepoint: 3rd and 5th Day after Intervention. Method of measurement: Observed Clinically.</prim_outcome>
      <prim_outcome>Implant Stability. Timepoint: 03 Months after Intervention. Method of measurement: Glickemans method.</prim_outcome>
      <prim_outcome>Per Op patient Compliance. Timepoint: immediately after intervention. Method of measurement: Licekrts Scale.</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>AFID</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-19</approval_date>
        <contact_name>Ethical Committee of AFID</contact_name>
        <contact_address>AFID CMH Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
