<?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>IRCT20260720070263N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-28</date_registration>
      <primary_sponsor>Foundation University Islamabad.</primary_sponsor>
      <public_title>Using an AI chatbot to facilitate case-based learning for undergraduate dental students.</public_title>
      <acronym>Chat-CBL TRIAL</acronym>
      <scientific_title>Effectiveness of Chatbot-facilitated Case based learning in Oral Pathology, a pilot randomized cross-over trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Other design features: Retrospective trial registration, Randomization description: Randomization

Participants were stratified according to previous Oral Pathology examination scores (high and
low academic performance) and randomly allocated in a 1:1 ratio using computer-generated
random numbers with permuted blocks of four.

Allocation Concealment
Group allocation was concealed using sequentially numbered opaque sealed envelopes
prepared by an independent researcher.

Blinding
Because of the nature of the educational intervention, participants and facilitators were not
blinded. Outcome assessment was performed using anonymized participant codes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Not applicable as outcomes are educational..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Participants were stratified based on their most recent Oral Pathology examination scores and randomized in a 1:1 ratio into two sequences: Sequence 1: Traditional CBL → Chatbot-CBL Description of Intervention :Phase 1 (Session 1 - Soft Tissue Pathology): Participants receive Traditional Case-Based Learning (CBL) guided by trained faculty facilitators using specific case materials, structures, and prompts. Washout Period: A two-week interval to minimize carryover effects. Phase 2 (Session 2 - Salivary Gland Pathology): Participants switch to Chatbot-CBL. Each group interacts with the chatbot using a shared device. The chatbot delivers case content stepwise (history, clinical findings, imaging, histopathology) and provides immediate feedback. Traditional CBL serves as control in sequence 1. Intervention 2: Intervention group 2: Sequence 2 (Chatbot-CBL → Traditional CBL) Description of Intervention: Phase 1 (Session 1 - Soft Tissue Pathology): Participants receive Chatbot-CBL. Each group interacts with the chatbot using a shared device. The chatbot delivers case content stepwise (history, clinical findings, imaging, histopathology) and provides immediate feedback. Washout Period: A two-week interval to minimize carryover effects .Phase 2 (Session 2 - Salivary Gland Pathology): Participants switch to Traditional CBL guided by trained faculty facilitators using identical case materials, structures, and prompts. Traditional CBL serves as control in this sequence 2.</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:
Data sharing statement mentioned at the end of manuscript i.e. available only on request.

When:
After publication of manuscript till 6 months.

To whom:
anyone working in academic institution.

Conditions:
Corresponding author can be contacted after article is published.

Where to obtain:
Contacting corresponding author.

How to obtain:
Anyone needing to replicate this study will contact the corresponding author via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amna Waheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>DHA 1, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>45000</zip>
        <telephone>+92 51 5788171</telephone>
        <email>amna.d891@gmail.com</email>
        <affiliation>Foundation University Islamabad.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amna Waheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>DHA Phase 1, Islamabad.</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>45000</zip>
        <telephone>+92 51 5788171</telephone>
        <email>amna.waheed@fui.edu.pk</email>
        <affiliation>Foundation University Islamabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Third-year BDS students.
Enrolled in the Oral Pathology course.
Able to understand English.
Provided written informed consent and willing to participate in both study sessions.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Third year BDS students who declined participation,
Or withdrew consent.
Or absent during either study session or the corresponding assessments.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Participants were stratified based on their most recent Oral Pathology examination scores and randomized in a 1:1 ratio into two sequences: Sequence 1: Traditional CBL → Chatbot-CBL Description of Intervention :Phase 1 (Session 1 - Soft Tissue Pathology): Participants receive Traditional Case-Based Learning (CBL) guided by trained faculty facilitators using specific case materials, structures, and prompts. Washout Period: A two-week interval to minimize carryover effects. Phase 2 (Session 2 - Salivary Gland Pathology): Participants switch to Chatbot-CBL. Each group interacts with the chatbot using a shared device. The chatbot delivers case content stepwise (history, clinical findings, imaging, histopathology) and provides immediate feedback. Traditional CBL serves as control in sequence 1.</i_keyword>
      <i_keyword>Intervention group 2: Sequence 2 (Chatbot-CBL → Traditional CBL) Description of Intervention: Phase 1 (Session 1 - Soft Tissue Pathology): Participants receive Chatbot-CBL. Each group interacts with the chatbot using a shared device. The chatbot delivers case content stepwise (history, clinical findings, imaging, histopathology) and provides immediate feedback. Washout Period: A two-week interval to minimize carryover effects .Phase 2 (Session 2 - Salivary Gland Pathology): Participants switch to Traditional CBL guided by trained faculty facilitators using identical case materials, structures, and prompts. Traditional CBL serves as control in this sequence 2.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome was the knowledge scores between both groups of students i.e. traditional case-based learning group and chat-bot facilitated case-based learning group. It was assessed using a 10-item multiple-choice question (MCQ) test administered before and after each case-based learning (CBL) session for both traditional and chatbot group. The MCQ assessment was developed specifically for this study based on the undergraduate Oral Pathology curriculum and reviewed for content validity by two subject experts. Timepoint: Knowledge was assessed using pre-test multiple-choice questions (MCQs) i.e. before the intervention; traditional &amp; chat-bot facilitated case-based learning (CBL) and after each intervention. Two weeks after the cross-over of groups in session 2 again pre and post-session knowledge assessed using MCQ as an instrument. Method of measurement: For both sessions MCQ based assessment was used which measured the knowledge scores obtained by students.</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>Foundation University Islamabad.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-19</approval_date>
        <contact_name>Foundation University School of Health Sciences Ethical Review Board.</contact_name>
        <contact_address>DHA 1, Islamabad. Islamabad. Islamabad. Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
