<?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>IRCT20210822052251N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-03</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of motivational interviewing on dental plaque index of adolescentes with bipolar mood disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effect of motivational interviewing on dental plaque index of adolescentes with bipolar mood disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: Participants, The person examining the adolescent's dental plaque index and the person who analyzes the data will not know in which study group the examined people are. Therefore, the study will be double-sided blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar mood disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in addition to receiving traditional health education, the intervention group will participate in 2 sessions of oral health education through interviews with an interval of 1 month and will receive motivation with the guidance of the Lental model. Motivational interviews will take approximately 15-20 minutes. Oral health information and instructions will be given to the patient during the motivational interview (depending on the patient). The questionnaire prepared for the study will be used as a title to start the interview. Addressing the five dimensions of Lonthal interview theory, this letter follows the principles of motivation (physicians 'empathy, contradiction of patients' importance and values ​​with their own opinion, and lack of direct argument or confrontation). The questionnaire will consist of five questions: 1- What is dental health for you? 2. What are the factors that contribute to oral health? 3- What are the consequences of dental problems for you in daily life? 4. What kind of oral care do you do for your gums regularly, even daily, and what factors may increase your gum and tooth problems? 5- What treatment methods can you have to restore healthy teeth and gums? Explanations of conversion methods will naturally be considered during the next discussion that will be created (for example, in the brushing test method). After a month, the dentist will make an appointment for an oral examination, and in the second initial session, the dental plaque index will be evaluated and recorded by a physician from a unique grouping, and will be recorded as a new thing according to the amount of plaque reduction during these periods. شد. The motivational interview will address the problems encountered while brushing and creating a feeling of improvement in the patient's use of the disease. After a month, he will be examined again by a dentist who is unaware of the groupings and his dental plaque index will be evaluated and recorded. Intervention 2: Control group: these people will receive routine hygiene training, which includes training to brush with the modified bass technique, flossing, and also showing the mouth using a mirror. After a week, the participants will be examined by a dentist and their dental plaque index will be evaluated and recorded.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kamran Delavizbonab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Golghasht avenue, Daneshgah street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3776 2825</telephone>
        <email>kamran.delaviz@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Yasamineh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Prosthesis section, Dentistry Faculty, Golgasht Street, Tabriz, Iran</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3334 6977</telephone>
        <email>yasamineh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering bipolar mood disorder
Adolescents  in the age range of 12 to 18 years
IQ above 70 adolescents which will be determined by raven test intelligence screening
written informed consent from the parent or legal guardian and oral assent from the adolescent
Cooperation and participation of adolescent in CBT classes</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of orthodontic applications
Existence of major psychiatric pathology other than BMD in adolescent
Taking other psychiatric medications by the adolescent
Lack of cooperation of the adolescent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar affective disorder, current episode hypomanic</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in addition to receiving traditional health education, the intervention group will participate in 2 sessions of oral health education through interviews with an interval of 1 month and will receive motivation with the guidance of the Lental model. Motivational interviews will take approximately 15-20 minutes. Oral health information and instructions will be given to the patient during the motivational interview (depending on the patient). The questionnaire prepared for the study will be used as a title to start the interview. Addressing the five dimensions of Lonthal interview theory, this letter follows the principles of motivation (physicians 'empathy, contradiction of patients' importance and values ​​with their own opinion, and lack of direct argument or confrontation). The questionnaire will consist of five questions: 1- What is dental health for you? 2. What are the factors that contribute to oral health? 3- What are the consequences of dental problems for you in daily life? 4. What kind of oral care do you do for your gums regularly, even daily, and what factors may increase your gum and tooth problems? 5- What treatment methods can you have to restore healthy teeth and gums? Explanations of conversion methods will naturally be considered during the next discussion that will be created (for example, in the brushing test method). After a month, the dentist will make an appointment for an oral examination, and in the second initial session, the dental plaque index will be evaluated and recorded by a physician from a unique grouping, and will be recorded as a new thing according to the amount of plaque reduction during these periods. شد. The motivational interview will address the problems encountered while brushing and creating a feeling of improvement in the patient's use of the disease. After a month, he will be examined again by a dentist who is unaware of the groupings and his dental plaque index will be evaluated and recorded.</i_keyword>
      <i_keyword>Control group: these people will receive routine hygiene training, which includes training to brush with the modified bass technique, flossing, and also showing the mouth using a mirror. After a week, the participants will be examined by a dentist and their dental plaque index will be evaluated and recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental plaque index. Timepoint: Before the intervention and one month after the end of the CBTsessions. Method of measurement: Disclosing solution.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-18</approval_date>
        <contact_name>Ethics committee of Tabriz university of medical sciences</contact_name>
        <contact_address>Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
