<?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>IRCT20220705055371N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-19</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of nylon and vicryl suture on the quality of wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of bacterial colonization in the quality of healing following the use of nylon and vicryl suturies in oral surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>29</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64606</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way and by using the option of generating random numbers on the Kitset.ir site and electronically. unit, candidates for bilateral wisdom tooth surgery. Based on the calculated sample size, random numbers are generated without repetition. Then, according to the generated numbers, a nylon suture thread is placed in the right side of the patient's jaw and in The left side of Vicryl suture thread is used and vice versa for the next number, Blinding description: The surgeon will know the suture used, but the patient does not know that a different suture will be used for him and what type of suture will be used on each side.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Comparison of the colonization of Staphylococcus aureus at the site of nylon and vicryl sutures in third molar surgeries. Condition 2: Comparison of colonization of enterococcus  bacteria at the site of nylon and vicryl sutures in third molar surgeries. Condition 3: Comparison of colonization of Escherichia coli [E. coli ]  bacteria at the site of nylon and vicryl sutures in third molar surgeries. Condition 4: Comparison of the colonization of Streptococcus mutans at the site of nylon and vicryl sutures in third molar surgeries. Condition 5: Comparison of the colonization of Other and unspecified infectious diseases grown at the site of nylon and vicryl sutures in third molar surgeries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Surgical site sutured with Vicryl suture. Intervention 2: Intervention group2: Surgical site with nylon suture.</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:
All data is potentially shareable after de-identifying individuals

When:
Access starts 6 months after the results are published

To whom:
The data will be accessible to researchers working in academic and scientific institutions and people who are also engaged in industry.

Conditions:
These data can be used with the intention of using them in medical work and after obtaining permission from the ethics committee and following legal procedures from the university and obtaining permission from the project manager and the research department of Babol Dental School.

Where to obtain:
To receive the desired documents, please send a message to the email below.
khashayarirload@yahoo.com

How to obtain:
After receiving the email and obtaining permission from the ethics committee and the research department of Babol University of Medical Sciences, documents or data files will be sent to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezo Javani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganj Afrooz St.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647754</zip>
        <telephone>+98 11 3223 5193</telephone>
        <email>m.kordinia@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezo Javani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganj Afrooz St.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647754</zip>
        <telephone>+98 11 3223 5193</telephone>
        <email>m.kordinia@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Good general health status
No specific systemic diseases or oral diseases 
Non-smoker</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age older than 35 years old
Poor health
Alcohol consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B95.6</hc_code>
      <hc_code>B95.2</hc_code>
      <hc_code>B96.2</hc_code>
      <hc_code>B95.4</hc_code>
      <hc_code>B99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Staphylococcus aureus as the cause of diseases classified elsewhere</hc_keyword>
      <hc_keyword>Enterococcus as the cause of diseases classified elsewhere</hc_keyword>
      <hc_keyword>Escherichia coli [E. coli ] as the cause of diseases classified elsewhere</hc_keyword>
      <hc_keyword>Other streptococcus as the cause of diseases classified elsewhere</hc_keyword>
      <hc_keyword>Other and unspecified infectious diseases</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: Surgical site sutured with Vicryl suture</i_keyword>
      <i_keyword>Intervention group2: Surgical site with nylon suture</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bacterial colonization rate. Timepoint: At the beginning of the study. Method of measurement: Based on preparation of warm slides and biochemical tests and according to diagnostic tables.</prim_outcome>
      <prim_outcome>The color of the oral mucosa. Timepoint: 7 days after tooth extraction. Method of measurement: Using the Hilling index modified from the article of Masse et al.</prim_outcome>
      <prim_outcome>The color and consistency of the restorative tissue. Timepoint: 7 days after tooth extraction. Method of measurement: Using the Hilling index modified from the article of Masse et al.</prim_outcome>
      <prim_outcome>The rate of pus discharge. Timepoint: 7 days after tooth extraction. Method of measurement: Using the Hilling index modified from the article of Masse et al.</prim_outcome>
      <prim_outcome>Bleeding rate. Timepoint: 7 days after tooth extraction. Method of measurement: Using the Hilling index modified from the article of Masse et al.</prim_outcome>
      <prim_outcome>Inflammatory reaction of tissue sample. Timepoint: 7 days after tooth extraction. Method of measurement: Observing the number of inflammatory cells under a microscope with a magnification of *400.</prim_outcome>
      <prim_outcome>Presence of bacterial colony in tissue sample. Timepoint: 7 days after tooth extraction. Method of measurement: The presence or absence of bacterial colonies under the microscope.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-04</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
