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Completed

NCT Number: NCT07698847

Patient Education and AI-Assisted Complaint Summaries in Endodontic Patients

The goal of this randomized clinical trial is to compare the same-day effects of three standardized patient education methods in adults presenting to an endodontic clinic with toothache.

The main questions it aims to answer are:

* Does standardized verbal education improve patients' knowledge, reduce antibiotic-related misconceptions, and reduce anxiety? * Does leaflet-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety? * Does video-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety? * Does teach-back performance differ according to the method used to deliver patient education? * Can an AI-assisted three-sentence complaint summary be generated reliably and used as a feasible clinician-facing communication support tool?

Participants will be randomly assigned to one of three patient education groups.

In the verbal education group, participants will receive a standardized 90-second verbal explanation covering warning signs, appropriate home-care measures, avoidance of potentially harmful practices, and appropriate antibiotic use.

In the leaflet-based education group, participants will review a written leaflet containing the same core educational messages for 90 seconds.

In the video-based education group, participants will watch a short video presenting the same core educational messages for 90 seconds.

Knowledge level, antibiotic-related misconceptions, and anxiety will be assessed immediately before and immediately after the educational intervention. After education, participants will also be asked to restate the main messages in their own words using a teach-back procedure.

In addition, symptom information collected using standardized prompts will be entered into an artificial intelligence tool to generate a concise three-sentence complaint summary. The feasibility, completeness, and clinician-rated usefulness of these summaries will be evaluated as process outcomes. AI-generated summaries will not be used for diagnosis, triage, or treatment decisions.

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Key information

Conditions

Toothache Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reported pain of at least 1 point on a 0-10 numeric rating scale (NRS ≥ 1) at presentation,
  • Were aged 18-65 years,
  • Had sufficient cognitive capacity to complete the questionnaires, and
  • Provided written informed consent.

Exclusion criteria

  • Reported no pain at presentation (NRS = 0) or presented electively/asymptomatically,
  • Required immediate emergency clinical evaluation due to signs suggestive of urgent intervention (e.g., marked diffuse swelling, dysphagia, dyspnea),
  • Had substantial communication or cognitive difficulties preventing completion of the measures, or
  • Were repeat participants (i.e., the same patient re-entering the study).

Treatment and study plan

Standardized Verbal Education

Behavioral

Participants received a standardized 90-second verbal education session immediately after baseline assessment. The education included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain. A standardized script was used to ensure consistency of content and sequence.

Leaflet-Based Education

Behavioral

Participants reviewed a written educational leaflet for 90 seconds immediately after baseline assessment. The leaflet included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain. The educational content was equivalent to that provided in the verbal and video groups.

Video-based education

Behavioral

Participants watched a 90-second educational video immediately after baseline assessment. The video included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain. The educational content was equivalent to that provided in the verbal and leaflet-based education groups.

Primary outcomes

  1. Change in Patient Knowledge Score

    Time frame: Immediately before the educational intervention and immediately after the educational intervention on the same day

    Patient knowledge will be assessed using an 8-item questionnaire developed according to the standardized educational content. Each item will be scored as 1 for a correct response and 0 for an incorrect or unsure response, yielding a total score ranging from 0 to 8. Higher scores indicate greater knowledge. The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the verbal, leaflet-based, and video-based education groups.

  2. Change in Antibiotic Misconception Score

    Time frame: Immediately before the educational intervention and immediately after the educational intervention on the same day

    Antibiotic-related misconceptions will be assessed using a 5-item Likert-type scale. Each item will be rated from 1 to 5, yielding a total score ranging from 5 to 25. Higher scores indicate stronger endorsement of antibiotic-related misconceptions. The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the three education groups.

  3. Change in Anxiety Level

    Time frame: Immediately before the educational intervention and immediately after the educational intervention on the same day

    Anxiety related to the presenting dental pain will be assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates no anxiety and 10 indicates the worst imaginable anxiety. The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the verbal, leaflet-based, and video-based education groups.

Secondary outcomes

  1. Teach-Back Critical Elements Score

    Time frame: Immediately after the educational intervention on the same day

    Immediately after the educational intervention, participants will be asked to restate the main educational messages in their own words within approximately 20-30 seconds. Teach-back performance will be evaluated using five predefined critical elements. Each element will be scored as present or absent, yielding a total score ranging from 0 to 5. Higher scores indicate more complete recall of the educational content.

  2. Teach-Back Global Adequacy Rating

    Time frame: Immediately after the educational intervention on the same day

    The overall adequacy of the participant's teach-back response will be rated on a 3-point scale ranging from 0 to 2. A score of 0 indicates an incorrect, unsafe, or markedly incomplete response; a score of 1 indicates a partially correct response with missing critical elements; and a score of 2 indicates a correct and adequate response.

  3. Generability of the AI-Assisted Complaint Summary

    Time frame: During the same clinical visit, after collection of standardized symptom information

    The ability to generate a concise three-sentence AI-assisted complaint summary from standardized, de-identified symptom information will be recorded as generated or not generated. The proportion of successfully generated summaries will be calculated for all participants.

  4. Completeness of the AI-Assisted Complaint Summary

    Time frame: Immediately after generation of the AI-assisted complaint summary during the same clinical visit

    The completeness of each AI-assisted complaint summary will be assessed according to the presence of five predefined symptom-related components. The completeness score will range from 0 to 5, with higher scores indicating more complete coverage of the required information.

  5. Clinician-Rated Usefulness of the AI-Assisted Complaint Summary

    Time frame: Immediately after review of the AI-assisted complaint summary during the same clinical visit

    The usefulness of the AI-assisted complaint summary for structuring the clinical encounter will be rated by a single endodontist on a numeric rating scale ranging from 0 to 10, where 0 indicates not useful at all and 10 indicates extremely useful.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

The Effect of Different Patient Education Methods in Patients Presenting to an Endodontic Clinic With Toothache and the Feasibility of an AI-Assisted Complaint Summary

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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