<?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>IRCT201201094877N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-11</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of toothbrush wear on plaque control</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of effect of toothbrush wear on plaque control in dental faculty students.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5221</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>This study will be conducted in prospective interventional method. Twenty six participants are selected from dental students. We will use Butler toothbrush and oral disclosures which both of them are made in America, and Crest 7 toothpaste is made in Germany. Individuals will brush for 12 weeks two times a day. At the baseline and at 6, 9, 12 weeks plaque index will measured with O'Leary technique and with use of disclosure tablets. In 6, 9, 12 weeks Toothbrush wear index will measured with Rawls technique. In the Bass technique toothbrush is placed on the tooth with an angle of about 45 degrees. So brush strings penetrate to the gingival sulcus. Then will given short - range vibrating moves in the anterior – posterior toothbrush. In every area of the teeth, twenty moving is recommended. In the palatal and lingual maxillary and mandibular anterior teeth due to space constraints, the toothbrush put vertically and teeth are cleaned individually with tip. In occlusal surfaces, toothbrush placed horizontally and  with low range of back - forward motions cleaning operation is carried.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Poursaadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of dentistry, Isfahan University of Medical Sciences. Hezar Jerib Street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2870</telephone>
        <email>Saeid_P22@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Ahmad Moghareh Abed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of periodontology, School of dentistry, Isfahan University of Medical Sciences.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 1792 2870</telephone>
        <email>Mogharehabed@dnt.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1- not to use orthodontic brackets&#13;
2- not to use fixed partial dentures&#13;
3- not to use antibiotics or any mouthwashes&#13;
4- no need for surgery in the mouth during the study,&#13;
5- or not suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level.&#13;
6- only right handed people are chosen.&#13;
Exclusion criteria:&#13;
1- using of orthodontic brackets&#13;
2- using of antibiotics or any mouth washes&#13;
3- need for surgery in the mouth during the study&#13;
4- using of fixed partial dentures&#13;
5- suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level  &#13;
6- Left handed people</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>28 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k03.6 , k0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deposits [accretions] on teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study will be conducted in prospective interventional method. Twenty six participants are selected from dental students. We will use Butler toothbrush and oral disclosures which both of them are made in America, and Crest 7 toothpaste is made in Germany. Individuals will brush for 12 weeks two times a day. At the baseline and at 6, 9, 12 weeks plaque index will measured with O'Leary technique and with use of disclosure tablets. In 6, 9, 12 weeks Toothbrush wear index will measured with Rawls technique. In the Bass technique toothbrush is placed on the tooth with an angle of about 45 degrees. So brush strings penetrate to the gingival sulcus. Then will given short - range vibrating moves in the anterior – posterior toothbrush. In every area of the teeth, twenty moving is recommended. In the palatal and lingual maxillary and mandibular anterior teeth due to space constraints, the toothbrush put vertically and teeth are cleaned individually with tip. In occlusal surfaces, toothbrush placed horizontally and  with low range of back - forward motions cleaning operation is carried</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plaque index. Timepoint: The beginning of study, Sixth Week, Ninth Week and Week Twelve. Method of measurement: After using of the disclosing tablets, the plaque index will be calculated using the following equation:  100 × {(number of teeth × 4) / number of stained (non occlusal surfaces)}.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Toothbrush wear. Timepoint: Sixth Week, Ninth Week, Twelfth Weeks. Method of measurement: All dimensions of brushes will be measured by digital caliper individually. Then brush wear index will be calculated using the following: WI = (FLL-BLL) + (FFL-BFL) / BRL  WI, brush wear index  FLL, Brystal length in the surface  BLL, Brystal length at the base  FFL, Brystal width in the surface  BFL, Brystal width at the base  BRL, the height of Brystl.</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>Vice chancellor for research, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-14</approval_date>
        <contact_name>Ethics of Isfahan University of Medical Sciences</contact_name>
        <contact_address>School of dentistry, Isfahan University of Medical Sciences. Hezar Jerib Street. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
