<?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>IRCT20221209056759N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-08</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Clinical comparison of sinus lift via piezosurgery and usual rotary techniques</public_title>
      <acronym></acronym>
      <scientific_title>Clinical comparison of sinus lift via piezosurgery and usual rotary techniques especially in terms of the pain after surgery in two sides of a single patient, in people who need bilateral sinus lift and implant in posterior sides of maxilla</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67344</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Other design features: With the exact design of the study in the form of split-mouth crossover, it is tried to eliminate intervening variables that may have confusing results, Randomization description: Block randomization method; It is with quadruple blocks with individual randomization unit. Excel software has also been used for randomization. Concealment has been done in such a way that two independent envelopes are available, one is available to the secretary and the other is available to the surgeon. With each patient's visit, the secretary assigns a row number to the patient based on the order of the visit (after meeting the entry and exit criteria). The surgeon has her own sealed envelope and acts based on it, Blinding description: Before participating in the trial, patients have a complete awareness of reciveing two therapeutic intervention through two surgical methodes; but they do not know that which surgery will be done first and which side (right or left) will get the surgery first.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sinus lift surgery.</hc_freetext>
      <i_freetext>Intervention group:Augmentin (Amoxicillin + Clavulanic acid) plus Acetaminophen 500 mg, is prescribed for all patients (three times a day or TDS) from one day before surgery until five days after surgery. On the day of surgery, after getting sufficient anesthesia by infiltration and anesthesia of posterior and middle superior alveolar nerves and also greater palatine nerve, patiant is prepared for surgery. 5 minutes before surgery, the patient keeps chlorhexidine mouthwash in his mouth for one minute. The surgical method is performed as a lateral_wall approach sinus lift. A crustal incision is made in the area of ​​the implant along with a vertical freeing incision in the distal of the flap. the mucoperiosteal flap is lifted. After complete reflection of the mucoperiosteal flap, osteotomy is performed in the lateral wall of the sinus using piezosurgery (US_11 LED piezo bone surgery Woodpecker) or rotary at a speed of 2000 rpm.After elevating the sinus membrane, implant is placed at the same time according to the manufacturer's protocol. Also, after evaluating the surgical site, Allogenous frozen-dried corticocancellous bone chips (from Iranian tissue product co. and particle size 1000-2000 micrometers) and absorbable membrane (from Brand Iranian tissue product co., size 20 x 30 mm and thickness 3. to 4. mm) is placed and the area is sutured with four-zero nylon thread..</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:
information gathered from the patients, is collected in the form of a file called sinus lift study data. All patient information can be provided after de-identification.

When:
Access will start from the year 1402.

To whom:
All people who want to access the data are allowed to do so.

Conditions:
In order to know the information obtained from the patients, they can use the data. The condition of accessing the data requires providing the person's purpose of access and research resume.

Where to obtain:
Applicants can request access to the data from Fateme Pooladvand. Email address: fatemepooladvand76@gmail.com They can also contact Dr. Ideh Talim Khani. Email address: ideatalimkhani@yahoo.com

How to obtain:
First, send their desired request. They must comply with the requested conditions and after conducting the necessary checks, this information will be provided to them. Consider the approximate and maximum time of 2 months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ideh Talimkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, 6th floor, Molavi medical building, Molavi Ave., Felestin Blvd., Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۶۶۵۳۹۹۲</zip>
        <telephone>+98 87 3322 7825</telephone>
        <email>ideatalimkhani@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ideh Talimkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, 6th floor, Molavi medical building, Molavi Ave., Felestin Blvd., Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۶۶۵۳۹۹۲</zip>
        <telephone>+98 87 3322 7825</telephone>
        <email>ideatalimkhani@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 18 years old
Needing bilateral sinus lift and implant for the posterior areas of maxilla
Systematically healthy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Immune system defect
Infection in poterior areas of maxilla
Sinusitis
Needing advanced bone surgery or transverse ridge augmentation
Destructive parafunctional habit
Pregnant or lactating women</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Augmentin (Amoxicillin + Clavulanic acid) plus Acetaminophen 500 mg, is prescribed for all patients (three times a day or TDS) from one day before surgery until five days after surgery. On the day of surgery, after getting sufficient anesthesia by infiltration and anesthesia of posterior and middle superior alveolar nerves and also greater palatine nerve, patiant is prepared for surgery. 5 minutes before surgery, the patient keeps chlorhexidine mouthwash in his mouth for one minute. The surgical method is performed as a lateral_wall approach sinus lift. A crustal incision is made in the area of ​​the implant along with a vertical freeing incision in the distal of the flap. the mucoperiosteal flap is lifted. After complete reflection of the mucoperiosteal flap, osteotomy is performed in the lateral wall of the sinus using piezosurgery (US_11 LED piezo bone surgery Woodpecker) or rotary at a speed of 2000 rpm.After elevating the sinus membrane, implant is placed at the same time according to the manufacturer's protocol. Also, after evaluating the surgical site, Allogenous frozen-dried corticocancellous bone chips (from Iranian tissue product co. and particle size 1000-2000 micrometers) and absorbable membrane (from Brand Iranian tissue product co., size 20 x 30 mm and thickness 3. to 4. mm) is placed and the area is sutured with four-zero nylon thread.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 24, 48, 72 hours and 1 week after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sinus perforation. Timepoint: During the surgery. Method of measurement: Surgeon's observation.</sec_outcome>
      <sec_outcome>Time of surgery. Timepoint: During surgery. Method of measurement: Minures.</sec_outcome>
      <sec_outcome>Field of view of the surgery. Timepoint: During the surgery. Method of measurement: Four point scale.</sec_outcome>
      <sec_outcome>Eating and sleeping. Timepoint: During the week after surgery. Method of measurement: Pittsburgh Sleep Quality Index and a valid questionnaire for Eating changes.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-02</approval_date>
        <contact_name>Ethics committe of Kurdistan University of medical sciences</contact_name>
        <contact_address>Ethics committe, second floor, medical faculty, Kurdistan medical University, Pasdaran Blvd Sanandaj Kurdistan Italy</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
