<?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>IRCT20190712044177N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Periodontal tissue thickness in orthodontics</public_title>
      <acronym></acronym>
      <scientific_title>Periodontal phenotype modification in orthodontic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thin periodontal phenotype in orthodontic patients.</hc_freetext>
      <i_freetext>Intervention group: All patients receive phase I periodontal therapy. In cases that surgery would be performed during orthodontic treatment, active treatment would be interrupted 3 weeks prior to the surgery and be postponed for 4 months following surgical intervention. Patients rinse their mouth with 0.2% chlorhexidine for 1 minute right before local anesthesia administration (20 mg/mL lidocaine with 1:80,000 epinephrine). An intracrevicular incision with a no.15c scalpel would be used to raise a full-thickness flap extended to two adjacent teeth mesiodistally and 5 mm beyond the mucogingival junction (MGJ) apically. Periosteal incisions would be made for passive flap advancement. The facial aspects of the interdental papillae would be deepithelialized with a microblade to allow final positioning of the flap margin coronal to the cementoenamel junction (CEJ). The exposed root surfaces would be thoroughly planed with a periodontal curette. Demineralized freeze-dried bone allograft (DFDBA; 500-1000 μm; Iranian Tissue Product Co., Tehran, Iran) would beplaced on the bone surface and be covered with a xenogeneic collagen matrix (Mucoderm®, Botiss Biomaterials, Germany). The collagen matrix would be secured with sling sutures (4-0 PLGA, Ethicon, Johnson &amp; Johnson, NJ, USA). Flap closure would be achieved with internal vertical mattress sutures (4-0 Nylon, Ethicon, Johnson &amp; Johnson, NJ, USA) at interdental areas..</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Kadkhodazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo Blvd, Evin, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2240 3075</telephone>
        <email>mahdi.sbmu@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Kadkhodazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo Blvd, Evin, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2240 3075</telephone>
        <email>mahdi.sbmu@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>≥18 years of age
Thin periodontal phenotype
Absence of gingival inflammation
Probing depth ≤ 3 mm
O’Leary plaque index &lt; 20%</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Poor oral hygiene
Cairo classification II/III gingival recession
Compromised immune system, systemic diseases, or intake of medications
Allergy to antibiotics or other medications to be prescribed
Pregnancy or breastfeeding in women
Presence of parafunctional habits (bruxism or clenching)
History of periodontal surgery over the past 12 months
Carious cervical lesions
External root resorption
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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: All patients receive phase I periodontal therapy. In cases that surgery would be performed during orthodontic treatment, active treatment would be interrupted 3 weeks prior to the surgery and be postponed for 4 months following surgical intervention. Patients rinse their mouth with 0.2% chlorhexidine for 1 minute right before local anesthesia administration (20 mg/mL lidocaine with 1:80,000 epinephrine). An intracrevicular incision with a no.15c scalpel would be used to raise a full-thickness flap extended to two adjacent teeth mesiodistally and 5 mm beyond the mucogingival junction (MGJ) apically. Periosteal incisions would be made for passive flap advancement. The facial aspects of the interdental papillae would be deepithelialized with a microblade to allow final positioning of the flap margin coronal to the cementoenamel junction (CEJ). The exposed root surfaces would be thoroughly planed with a periodontal curette. Demineralized freeze-dried bone allograft (DFDBA; 500-1000 μm; Iranian Tissue Product Co., Tehran, Iran) would beplaced on the bone surface and be covered with a xenogeneic collagen matrix (Mucoderm®, Botiss Biomaterials, Germany). The collagen matrix would be secured with sling sutures (4-0 PLGA, Ethicon, Johnson &amp; Johnson, NJ, USA). Flap closure would be achieved with internal vertical mattress sutures (4-0 Nylon, Ethicon, Johnson &amp; Johnson, NJ, USA) at interdental areas.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tissue thickness. Timepoint: At least 6 months postoperatively. Method of measurement: Gingival thickness would be measured using a an endodontic spreader placed in the center of a silicone stopper and inserted perpendicularly from the midbuccal point (3 mm apical to the gingival margin) through the soft tissues to reach a hard surface.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Probing depth; bleeding on probing; O’Leary plaque index; gingival recession; vestibular depth. Timepoint: At least 6 months postoperatively. Method of measurement: Probing depth would be measured at 4 points (mesial, distal, midbuccal, and midlingual) from the gingival margin to the bottom of the sulcus. Subsequently, a mean value of the measurements would be calculated for each tooth. Bleeding on probing would be recorded within 60 seconds of probing depth measurement. Gingival recession would be measured from gingival margin to the cementoenamel junction. Vestibular depth would be measured from the midbuccal gingival margin to the mucobuccal fold, while a retractor was placed in the mouth and teeth would be in occlusion. The periodontal probe would be held vertically across the vestibule in line with the axis of each tooth.</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>2020-02-01</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Daneshjoo Blv., Evin, Shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
