<?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>IRCT20241204063947N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Socket Preservation with Collagen and Its Impact on Post-Extraction Healing</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Evaluation of the Impact of Socket Preservation Using Collagen-Based Clot Retention Compared to Conventional Methods on Wound Healing Following Tooth Extraction in Patients Requiring Tooth Extraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The treatment boxes are sealed with 10-digit codes, and each code contains either the original treatment (clot-preserving collagen) or the alternative treatment (no clot-preserving collagen). The researcher will ensure that patients are completely unaware of their treatment by closely monitoring the treatment process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atraumatic tooth extraction, soft tissue healing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The tooth extraction was performed conservatively and bilaterally. On one side, the dental socket was managed using natural collagen (Collacone, Botiss Biomaterials, Germany). For this purpose, after administering local anesthesia with (Persocaine-E; Daroupakhsh, Tehran, Iran), the periodontal ligaments were separated using a periosteal elevator, and the tooth was extracted conservatively using universal forceps (Aesculap Co, USA) with vertical and rotational pressure. In the intervention group, a piece of Collacone with dimensions (e.g., 10 × 10 × 5 mm, if specified) was placed inside the dental socket. The socket opening was then closed using 4-0 Vicryl absorbable sutures (Ethicon, Johnson &amp; Johnson, NJ, USA) in a horizontal mattress technique. Intervention 2: Control group: The same surgical and suturing procedures were followed, but no collagen material was applied.Postoperative care instructions, including oral hygiene guidelines, dietary recommendations, and pain management with Gelofen (Ibuprofen 400 mg, Daana Pharma, Iran), were provided. Sutures were removed one week postoperatively.</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 We do not share the data. Individual participant data will not be published due to ethical considerations and patient privacy concerns.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 23871</telephone>
        <email>zeinabbakhtiari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 23871</telephone>
        <email>zeinabbakhtiari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy people without systemic diseases
Adults aged 18 to 65 years
Patients undergoing simple tooth extraction
Patients who are candidates for extraction of bilateral premolars for orthodontic treatment
Patients who provided full and informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are prohibited from performing dental procedures
History of allergy to collagen or related substances
Presence of active oral infections
Using immunosuppressive drugs or antibiotics
Smoking</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>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The tooth extraction was performed conservatively and bilaterally. On one side, the dental socket was managed using natural collagen (Collacone, Botiss Biomaterials, Germany). For this purpose, after administering local anesthesia with (Persocaine-E; Daroupakhsh, Tehran, Iran), the periodontal ligaments were separated using a periosteal elevator, and the tooth was extracted conservatively using universal forceps (Aesculap Co, USA) with vertical and rotational pressure. In the intervention group, a piece of Collacone with dimensions (e.g., 10 × 10 × 5 mm, if specified) was placed inside the dental socket. The socket opening was then closed using 4-0 Vicryl absorbable sutures (Ethicon, Johnson &amp; Johnson, NJ, USA) in a horizontal mattress technique.</i_keyword>
      <i_keyword>Control group: The same surgical and suturing procedures were followed, but no collagen material was applied.Postoperative care instructions, including oral hygiene guidelines, dietary recommendations, and pain management with Gelofen (Ibuprofen 400 mg, Daana Pharma, Iran), were provided. Sutures were removed one week postoperatively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Soft tissue healing. Timepoint: At baseline (immediately post-extraction), and at 14 and 28 days after the procedure. Method of measurement: Wound closure and presence of any signs of infection or inflammation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain level. Timepoint: At baseline (immediately post-extraction), and at 14 and 28 days after the procedure. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Infection rate. Timepoint: At baseline (immediately post-extraction), and at 14 and 28 days after the procedure. Method of measurement: Clinical evaluation for signs of infection such as redness, swelling, pus, or increased pain at the extraction site.</sec_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: At baseline (immediately post-extraction), and at 14 and 28 days after the procedure. Method of measurement: 5-point Likert scale, where 1 is "very dissatisfied" and 5 is "very satisfied.".</sec_outcome>
      <sec_outcome>Swelling. Timepoint: At baseline (immediately post-extraction), and at 14 and 28 days after the procedure. Method of measurement: Visual Analogue Scale.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-20</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
