<?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>IRCT20230624058570N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Mobile-based Application on Dental plaque, Gingivitis and White spot lesions in Pregnant Women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Mobile-based Self-care Application for Oral-dental Hygiene of Pregnant Women on Dental plaque, Gingivitis and White spot lesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research sample will be 70 pregnant women referring to the oral and dental health unit of the health network covered by Mazandaran University of Medical Sciences. The people of the sample group will be divided into two control groups (35 people) and intervention (35 people) with the randomization tool of the sealed envelope. In this study, the dentist providing the common principles of oral and dental hygiene and the dentist evaluating the results will not know about the presence of each patient in the control and intervention groups. Also, pregnant women will be blinded to grouping, Blinding description: In this study, the dentist providing the common principles of oral and dental hygiene and the dentist evaluating the results will not know about the presence of each patient in the control and intervention groups. Also, pregnant women will be blinded to grouping. Therefore, the present study will be conducted as a double-blind randomized clinical trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral-Dental Hygiene.</hc_freetext>
      <i_freetext>Intervention 1: Control group: People in the control group will receive the oral-dental hygiene principles orally by the dentist. In addition, brochures prepared about oral-dental hygiene will be given to the control group. Intervention 2: Intervention group: Pregnant women in the intervention group, in addition to receiving oral-dental hygiene principles and oral-dental hygiene brochures, will also receive a mobile-based self-care application.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of a systematic review along with the oral-dental health application and the effect of the mobile application on dental plaque, gingivitis index and white spot lesions in pregnant women.

When:
از سال 1400

To whom:
Researchers interested in the subject of this study

Conditions:
For use in selecting or designing a mobile -based self-care application on oral-dental hygiene for Pregnant Women

Where to obtain:
sadoughi.f@gmail.com

How to obtain:
After receiving the data request email, the data will be sent to the researcher within 1 week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farahnaz Sadoughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr St. (AJ), above Mirdamad, Rashid Yasmi St., Faculty of Medical Information and Management</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>02188883334</zip>
        <telephone>+98 21 8879 4301</telephone>
        <email>sadoughi.f@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Sadoughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr St. (AJ), above Mirdamad, Rashid Yasmi St., Faculty of Medical Information and Management</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>02188883334</zip>
        <telephone>+98 21 8879 4301</telephone>
        <email>sadoughi.f@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 25 and 35 years
Willingness to participate in the study
Having a smart phone
Ability to work with applications
Gestational age of the second and third trimesters of pregnancy (from the 15th week to the end of delivery)
Pregnant women without tooth decay and gum disease</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having mental and physical disability
Having oral and dental diseases
Using drugs that affect the accumulation of dental plaque, such as antibiotics and antibacterial mouthwashes</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>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: People in the control group will receive the oral-dental hygiene principles orally by the dentist. In addition, brochures prepared about oral-dental hygiene will be given to the control group.</i_keyword>
      <i_keyword>Intervention group: Pregnant women in the intervention group, in addition to receiving oral-dental hygiene principles and oral-dental hygiene brochures, will also receive a mobile-based self-care application.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental plaque index. Timepoint: At the beginning of the study (before the intervention), one month after using the application and three months after using the application. Method of measurement: Plaque disclosing tablet and Plaque ontrol record (O'Leary index).</prim_outcome>
      <prim_outcome>Gingival Index (GI). Timepoint: At the beginning of the study (before the intervention), one month after using the application and three months after using the application. Method of measurement: Loe and sillness index.</prim_outcome>
      <prim_outcome>White spot lesions. Timepoint: At the beginning of the study (before the intervention), one month after using the application and three months after using the application. Method of measurement: Visual examination method.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-12</approval_date>
        <contact_name>Ethics committee Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
