NCT07698847

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Immediately before the educational intervention and immediately after the educational intervention on the same day

  • 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.

    Immediately before the educational intervention and immediately after the educational intervention on the same day

  • 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.

    Immediately before the educational intervention and immediately after the educational intervention on the same day

Secondary Outcomes (5)

  • Teach-Back Critical Elements Score

    Immediately after the educational intervention on the same day

  • Teach-Back Global Adequacy Rating

    Immediately after the educational intervention on the same day

  • Generability of the AI-Assisted Complaint Summary

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

  • Completeness of the AI-Assisted Complaint Summary

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

  • Clinician-Rated Usefulness of the AI-Assisted Complaint Summary

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

Study Arms (3)

Standardized Verbal Education

ACTIVE COMPARATOR

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

Leaflet-Based Education

EXPERIMENTAL

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

Video-Based Education

EXPERIMENTAL

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

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.

Standardized Verbal 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.

Leaflet-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.

Video-Based Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 39075457BACKGROUND

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

December 15, 2025

Primary Completion

March 12, 2026

Study Completion

April 24, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations