<?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>IRCT20180714040460N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of hyaluronic acid gel</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of hyaluronic acid gel on the stability of dental implants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be selected from among the patients who have two posterior edentulous areas (teeth 4 to 7) in the upper or lower jaw with specific entry and exit criteria who are candidates for receiving implants in these areas. The sampling method is based on the target and continues until the desired number is reached, and then randomization is done using a coin in each person to allocate two areas to the test and control groups, Blinding description: The placement of the implant and the times determined by an examiner who was completely blinded to the surgical procedure are performed.</study_design>
      <phase>2</phase>
      <hc_freetext>Investigating the effect of hyaluronic acid gel on the stability of dental implants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 16 patients who are candidates for implant treatment, who have two posterior edentulous areas in the upper or lower jaw without the need for bone, without fenestration and synthesis and bone infection, are selected. In the intervention group, after preparing the osteotomy cavity according to the company's drilling sequence, the implants are randomly placed in one of the cavities with 0.4 ml of hyaluronic acid gel. Intervention 2: Control group:16 patients who are candidates for implant treatment, who have two posterior edentulous areas in the upper or lower jaw, without the need for bone, without fenestration and synthesis and bone infection, are selected. In the control group, after preparing the osteotomy cavity according to the drilling sequence of the company, the implants are placed in the cavities without any changes.</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>Nima Nadafpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, 10th Neyestan Ave., Pasdaran Ave.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>n_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima Nadafpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Pasdaran St., Nistan 9th</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998798331</zip>
        <telephone>+98 21 2676 7768</telephone>
        <email>n_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years of age 
Patients with O'LEARY Index (plaque control index) less than 20%
Having two posterior edentulous areas in the upper or lower jaw (teeth 4 to 7)
No need for BONE AUGMENTATION and no fenestration and desensation
No need for BONE AUGMENTATION and no fenestration and desensation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic disease such as uncontrolled diabetes, malignancy, head and neck radiotherapy, autoimmune disease that makes soft and hard tissue repair difficult 
Pregnancy
Need GBR
The implant cannot be placed in one step and it needs to be submerged
Presence of pain, swelling and infection in the surgical area
Smoking
Alcohol consumption
Use of steroids and drugs affecting periodontal tissues and bisphosphonates</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries on pit and fissure surface penetrating into dentin</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: 16 patients who are candidates for implant treatment, who have two posterior edentulous areas in the upper or lower jaw without the need for bone, without fenestration and synthesis and bone infection, are selected. In the intervention group, after preparing the osteotomy cavity according to the company's drilling sequence, the implants are randomly placed in one of the cavities with 0.4 ml of hyaluronic acid gel.</i_keyword>
      <i_keyword>Control group:16 patients who are candidates for implant treatment, who have two posterior edentulous areas in the upper or lower jaw, without the need for bone, without fenestration and synthesis and bone infection, are selected. In the control group, after preparing the osteotomy cavity according to the drilling sequence of the company, the implants are placed in the cavities without any changes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Implant stability (based on ISQ changes). Timepoint: Before the intervention and after 2, 4 and 8 weeks after placing the fixture. Method of measurement: Penguin RFA device.</prim_outcome>
      <prim_outcome>Hyaluronic acid. Timepoint: Before starting the intervention. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Implant stability (based on ISQ changes). Timepoint: Before the intervention and after 2, 4 and 8 weeks after placing the fixture. Method of measurement: Penguin RFA device.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-30</approval_date>
        <contact_name>Ethics Committee of Tehran Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>No. 9, Nistan 9th, Pasdaran St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
