<?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>IRCT20230310057665N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the occlusal adjustment on orthodontic's relaps by T-scan III</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of occlusal adjustment on relapse after orthodontic treatment by T-scan III</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, permutation block method is used to generate random allocation sequences of people to study groups. The random assignment sequence of people is performed using random allocation software and block size two. Permutation blocks method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks AB and BA. If the first block, AB, is chosen, the first is assigned to group A and the second to group B. And this process continues until the allocation of all samples. The feature of this method is that the two study groups will have equal numbers, Blinding description: Due to the nature of the work, the experimenter and the tested people cannot be blinded, and the people who analyze the results at the end of the work are blind. The cassettes are only given to the analyst by number.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating orthodontic relapse using T-scan III.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Inclusion criteria would be patients undergoing fixed orthodontic treatment with MBT prescription brackets with bimaxillary protrusion or with 4mm crowding or more. After debonding, a plaster mold would be created from both dentitions. Then they would be instructed to use their ESSIX VFR retainers for one month full-time and one-month part-time. One-month after debonding and wearing retainers full time, occlusal adjustment would be done by selectively grinding occlusal contacts to mitigate the precursors for potential orthodontic relapse and dental relationship would be then evaluated by T-scan device. Six months after debonding, plaster casts would be made again, and dental relations would be evaluated by T-scan device. By comparing the initial and final plaster casts, relapse would be assesed. Intervention 2: Control group: the conditions are completely similar to the intervention group, but after complete debonding, occlusal adjustment is not done, and patients are evaluated with a T-scan device immediately after debonding, 1 month after debonding, and 6 months after debonding, and also immediately after  debonding and 6 months after debonding, casting is done with alginate and the primary and secondary casts are compared to check the amount of relaps.</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>Arezoo Jahanbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry,in front of Mellat park,Vakilabad BLV</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>0098518829501</telephone>
        <email>JahanbinA@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Jahanbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry,in front of Mellat park,Vakilabad blv</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>JahanbinA@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 17-30 years of age
with class 1 dental malocclusion
with double jaw tooth protrusion or crowding more than 4 mm
underwent fixed orthodontic treatment
with extraction of 4 first premolar teeth of two jaws
underwent fixed orthodontic treatment with MBT 0.22 bracket system.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with parafunction habit
systemic disease
poor oral hygiene
Gingivitis or periodontal problems or deep caries that have spread to the cement enamel junction
Taking drugs that affect bone metabolism, such as drugs that prevent bone resorption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anomalies of dental arch relationship</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Inclusion criteria would be patients undergoing fixed orthodontic treatment with MBT prescription brackets with bimaxillary protrusion or with 4mm crowding or more. After debonding, a plaster mold would be created from both dentitions. Then they would be instructed to use their ESSIX VFR retainers for one month full-time and one-month part-time. One-month after debonding and wearing retainers full time, occlusal adjustment would be done by selectively grinding occlusal contacts to mitigate the precursors for potential orthodontic relapse and dental relationship would be then evaluated by T-scan device. Six months after debonding, plaster casts would be made again, and dental relations would be evaluated by T-scan device. By comparing the initial and final plaster casts, relapse would be assesed.</i_keyword>
      <i_keyword>Control group: the conditions are completely similar to the intervention group, but after complete debonding, occlusal adjustment is not done, and patients are evaluated with a T-scan device immediately after debonding, 1 month after debonding, and 6 months after debonding, and also immediately after  debonding and 6 months after debonding, casting is done with alginate and the primary and secondary casts are compared to check the amount of relaps.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intercanine width. Timepoint: Pre intervention,6months after intervention. Method of measurement: Image J software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Root paralleling. Timepoint: 1 month before the intervention and 6 months after the intervention. Method of measurement: Image J software.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-15</approval_date>
        <contact_name>Ethics Committee of Faculty of Dentistry, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Dentistry faculty,in front of Mellat park,Vakilabad blv,Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
