<?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>IRCT20230428058016N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-05</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of educational program on improving the oral and dental health of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>Designing, implementing and evaluation an educational program to improve the oral and dental health of the elderly in Hamadan city in 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>577</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69868</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method in this study is a multi-stage cluster. Sampling will be done using a random number table. For this purpose, a list of all comprehensive health centers will be received first, and a two-digit code will be given to each comprehensive health center (codes 01 to 35 for comprehensive health centers). To choose a comprehensive health center, refer to the table of random numbers and select the starting point. The starting point will be done by closing the eyes and placing a finger or the tip of the pen on the table. Then it will move in the direction of the line based on the adjacent two-digit numbers. In this path, two types of numbers are encountered, one of which is smaller than the total number of comprehensive health centers and the other type is larger than the number of comprehensive health centers. Only smaller numbers will be selected for sampling. The selected number is actually the central code that is selected as a sample. Then, the elderly of each center will be included in the study based on having the entry and exit criteria.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: The second intervention group: The training program in this group will include 6 face-to-face training sessions for the elderly during four months. Also, a brochure will be prepared for geriatric nurses, which will provide tips on the importance of oral and dental hygiene and its role in public health, and the goals and implementation of the intervention program. Interventions in the elderly are carried out with the help of support groups. The elderly will be trained in the following areas: the importance of oral and dental hygiene, knowledge of tooth and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases . Intervention 2: Control group: Receive routine programs and training.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
People who intend to use the study data for review articles and meta-analysis

Where to obtain:
Mahboubeh Babaei email

How to obtain:
After checking the requester's email by Zeinab Mosayebi, if the conditions are met, the data will be sent to them 3 days later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboubeh Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan university of medical sciences, Fahmideh St</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۶۷۸</zip>
        <telephone>+98 81 3252 0182</telephone>
        <email>m.babaee74@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan university of medical sciences, Fahmideh St</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۶۷۸</zip>
        <telephone>+98 81 3252 0182</telephone>
        <email>m.babaee74@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age of 65 years
Having informed consent</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with complete edentulism</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>Intervention group:Intervention group: The second intervention group: The training program in this group will include 6 face-to-face training sessions for the elderly during four months. Also, a brochure will be prepared for geriatric nurses, which will provide tips on the importance of oral and dental hygiene and its role in public health, and the goals and implementation of the intervention program. Interventions in the elderly are carried out with the help of support groups. The elderly will be trained in the following areas: the importance of oral and dental hygiene, knowledge of tooth and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases .</i_keyword>
      <i_keyword>Control group: Receive routine programs and training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people who brushed twice a day with a toothpaste containing fluoride. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
      <prim_outcome>Use dental floss at least once a day. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
      <prim_outcome>Mouthwash use. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determining the rate of periodontal tissue health of each person. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Clinical examination by a dentist.</sec_outcome>
      <sec_outcome>Determining the rate of dental debris and calculus in each person. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Clinical examination by a dentist.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-08</approval_date>
        <contact_name>Ethics committee of Hamadan University of medical sciences</contact_name>
        <contact_address>Hamadan University of medical science, Shahid Fahmide Boulevards Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
