ToothacheNCT07698847
Patient Education and AI-Assisted Complaint Summaries in Endodontic Patients
A study testing Standardized Verbal Education, Leaflet-Based Education and Video-Based Education in people with Toothache and Dental Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Toothache, Dental Pain
- What is being tested?
- Standardized Verbal Education, Leaflet-Based Education and Video-Based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 24 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Toothache, Dental Pain
- Being tested
- Standardized Verbal Education, Leaflet-Based Education, Video-Based Education
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Verbal EducationBehavioural
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 EducationBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Video-Based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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, 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.
Measured: Immediately after the educational intervention on the same day
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.
Measured: Immediately after the educational intervention on the same day
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.
Measured: During the same clinical visit, after collection of standardized symptom information
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.
Measured: Immediately after generation of the AI-assisted complaint summary during the same clinical visit
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.
Measured: Immediately after review of the AI-assisted complaint summary during the same clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Dec 2025
- Primary completion12 Mar 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToothacheStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698847
- Sponsor's protocol ID
- 13.03.2026/104
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07698847
- Acronym / sponsor ID
- 13.03.2026/104
- Conditions
- Toothache, Dental Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized Verbal Education | Active comparator | Behavioral: Standardized Verbal EducationParticipants 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. |
| Leaflet-Based Education | Experimental | Behavioral: Leaflet-Based EducationParticipants 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. |
| Video-Based Education | Experimental | Behavioral: Video-Based EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Verbal EducationParticipants 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. | Behavioural | Standardized Verbal Education |
| Leaflet-Based EducationParticipants 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. | Behavioural | Leaflet-Based Education |
| Video-Based EducationParticipants 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. | Behavioural | Video-Based Education |
Primary outcome
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.
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.
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.
5 secondary outcomes
Teach-Back Critical Elements Score
Time frame: Immediately after the educational intervention on the same day
Teach-Back Global Adequacy Rating
Time frame: Immediately after the educational intervention on the same day
Generability of the AI-Assisted Complaint Summary
Time frame: During the same clinical visit, after collection of standardized symptom information
Completeness of the AI-Assisted Complaint Summary
Time frame: Immediately after generation of the AI-assisted complaint summary during the same clinical visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 39075457Nassar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Verbal Education, Leaflet-Based Education and Video-Based Education in people with Toothache and Dental Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Knowledge Score (time frame: Immediately before the educational intervention and immediately after the educational intervention on the same day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.