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CompletedNCT07698847Updated Jul 13, 2026

Patient Education and AI-Assisted Complaint Summaries in Endodontic Patients

An interventional study of Standardized Verbal Education and Leaflet-Based Education in Toothache and Dental Pain, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Cukurova University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Toothache
  • Dental Pain

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03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's enrollment of 120 is above the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Standardized Verbal Education

    Participants received a standardized 90-second verbal education session immediately after baseline assessment. The education covered warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain. The content and sequence were delivered using a standardized script.

    Behavioral: Standardized Verbal Education

  • Experimental
    Leaflet-Based Education

    Participants reviewed a written educational leaflet for 90 seconds immediately after baseline assessment. The leaflet contained the same core messages as the verbal education, including warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain.

    Behavioral: Leaflet-Based Education

  • Experimental
    Video-Based Education

    Participants watched a 90-second educational video immediately after baseline assessment. The video presented the same core messages as the verbal and leaflet-based education, including warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain.

    Behavioral: Video-Based Education

Interventions

  • BehavioralStandardized Verbal Education

    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.

  • BehavioralLeaflet-Based Education

    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.

  • BehavioralVideo-Based Education

    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.

06

What researchers measure

Primary outcomes

  1. Change in Patient Knowledge Score

    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.

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

  2. Change in Antibiotic Misconception Score

    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.

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

  3. Change in Anxiety Level

    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.

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

Secondary outcomes

  1. Teach-Back Critical Elements Score

    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.

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

  2. Teach-Back Global Adequacy Rating

    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.

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

  3. Generability of the AI-Assisted Complaint Summary

    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.

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

  4. Completeness of the AI-Assisted Complaint Summary

    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.

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

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

    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.

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

07

Study locations

1 site
  • Cukurova University
    Adana, Sarıçam 01250, Turkey (Türkiye)
08

References and documents

Publications

  • Nassar AA, Aboalshamat KT, Alsanei BS, Alghamdi AS, Fudah AA, Alhilou AM. The effect of educational animation compared to leaflets on patients' knowledge regarding root canal treatment: a randomized controlled trial. BMC Med Educ. 2024 Jul 29;24(1):808. doi: 10.1186/s12909-024-05812-5. PubMed 39075457 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07698847
Responsible party
Kübra Gürler (Principal Investigator, Cukurova University) — Principal investigator
First posted
Jul 13, 2026
Start date
Dec 15, 2025
Primary completion
Mar 12, 2026
Completion
Apr 24, 2026
Last update
Jul 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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