Comparing a Mobile App, AI Chatbot, and Printed Materials to Improve Parents' Dental Trauma Knowledge and Emergency Decisions (TRAUMA-AI)

November 3, 2026 updated by: Bikash Chaurasia, Lincoln University College

Comparative Effectiveness of a Mobile Application, an Artificial Intelligence Chatbot, and Traditional Print Resources on Parental Knowledge and Emergency Decision-Making for Dental Trauma in Children: A Three-Arm, Parallel-Group, Randomized Controlled Trial

Dental trauma in children may require prompt decisions by parents or caregivers. This three-arm randomized trial will compare a mobile application, an artificial intelligence chatbot, and a printed dental-trauma first-aid booklet as methods of delivering parental education. Approximately 220 parents or legal guardians will be allocated in a 1:1:1 ratio and will receive their assigned educational resource over four weeks. Parental dental-trauma knowledge and accuracy of responses to simulated emergency scenarios will be assessed at four weeks, with follow-up assessments at 12 weeks. Additional measures include confidence, usability, engagement, recognition of avulsion management, and anxiety. The study is planned in Selangor, Malaysia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This interventional, parallel-group, three-arm randomized controlled trial will evaluate educational modalities for parents/legal guardians of children. Participants will be recruited from the paediatric dentistry outpatient clinic and community/school outreach in the Petaling Jaya/Kelana Jaya area. Participants will be allocated using a computer-generated, concealed 1:1:1 sequence with randomly varied permuted blocks of 3 and 6, stratified by child age category and parental education (final age categories to be reconciled). Arm 1 receives a smartphone app with approximately six short interactive modules, stepwise first-aid algorithms, audiovisual content and quizzes, plus a 10-minute orientation and reminders on days 7 and 14. Arm 2 receives access to an AI chatbot restricted to a curated, guideline-based dental-trauma knowledge base, providing interactive responses to parent questions; research staff review logs for safety. Arm 3 receives a roughly 12-page A5 printed dental-trauma first-aid booklet with a standardized two-minute handover and no scheduled reminders. All three resources address common dental injuries using the same core evidence-based guidance. The intervention period is four weeks and follow-up continues to 12 weeks after randomization. Outcomes will be assessed with study-specific knowledge and simulated decision-making instruments, confidence and satisfaction measures, and modality-specific engagement metrics. Outcome assessors and data analysts are intended to be blinded, while participants and educators cannot be masked. Analyses are planned under intention-to-treat principles, using adjusted comparisons at four weeks and mixed-effects models for repeated observations; the final analysis plan will specify multiplicity and missing-data handling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parent or legal guardian of at least one child aged 2-14 years [VERIFY against study summary of 2-12].
  • Able to read and understand Malay or English.
  • Has regular access to an internet-enabled smartphone.
  • Able and willing to provide written informed consent.
  • No previous formal training in first aid, nursing, medicine or dentistry.

Exclusion Criteria:

  • Formal healthcare, paramedical, nursing, medical or dental qualifications/training.
  • Structured dental-trauma or first-aid education in the preceding 6 months.
  • Unable to access or use the smartphone app or chatbot (e.g., no compatible device or internet access).
  • Parent of a child with special healthcare needs for whom emergency dental management differs substantially from standard guidance.
  • Declines informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dental Trauma First-Aid Mobile Application

Parents receive a purpose-built mobile application containing approximately six modules with guideline-based dental trauma recognition and first-aid instruction, videos, diagrams, decision algorithms and quizzes. A trained assistant provides an approximately 10-minute orientation. Participants are encouraged to complete the modules within two weeks and may access the app throughout four weeks, with reminders on days 7 and 14.
Behavioral: Printed Dental Trauma First-Aid Booklet

Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected.
Experimental: Dental Trauma AI Chatbot

Parents receive a link or QR code to an AI chatbot that answers free-text dental-trauma first-aid questions and offers guided scenarios based on a curated guideline-based knowledge base. Access is on demand throughout the four-week intervention; no minimum session count is required. Research staff review chat logs for safety.
Behavioral: Printed Dental Trauma First-Aid Booklet

Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected.
Active Comparator: Printed Dental Trauma First-Aid Booklet

Parents receive an approximately 12-page A5 printed booklet with the same core dental-trauma first-aid education. A standardized two-minute handover is provided, without scheduled follow-up reminders; booklet use is self-directed over four weeks.
Behavioral: Printed Dental Trauma First-Aid Booklet

Printed educational material with diagrams and action checklists for dental avulsion, luxation, fractures and soft-tissue injury. Self-reported reading frequency and duration are collected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parental Knowledge of Dental Trauma Emergency Management at Week 4
Time Frame: Baseline and 4 weeks after randomization (primary comparison at week 4)

Measured by the study-specific 20-item Parental Dental Trauma Knowledge Questionnaire (PDTKQ), comprising multiple-choice items based on dental-trauma first-aid guidance. Scores range from 0 to 100; higher scores indicate better knowledge. Primary analysis compares week-4 scores between randomized groups, adjusting for baseline scores.
Baseline and 4 weeks after randomization (primary comparison at week 4)
Dental Trauma Emergency Decision-Making Accuracy at Week 4
Time Frame: 4 weeks after randomization (primary comparison); 12-week results recorded separately as follow-up

Measured by a study-specific Dental Trauma Emergency Decision-Making Scenario Test comprising five clinical vignettes addressing avulsion, luxation, crown/root fracture and soft-tissue injury. Scored from 0 to 100 for correctness, completeness and timeliness; higher scores represent more accurate decisions.
4 weeks after randomization (primary comparison); 12-week results recorded separately as follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge Retention at Week 12
Time Frame: 4 and 12 weeks after randomization

Change in PDTKQ score from week 4 to week 12 (0-100 scale; positive values indicate increased knowledge).
4 and 12 weeks after randomization
Parent Confidence in Dental Emergency Management
Time Frame: Baseline, 4 and 12 weeks after randomization

Study-specific 10-item confidence scale with responses scored 0-10 per item. Specify sum/mean and exact final range before submission.
Baseline, 4 and 12 weeks after randomization
Satisfaction With Assigned Education Resource
Time Frame: 4 weeks after randomization

Study-specific 12-item satisfaction survey administered in all three groups; define scoring and interpretation in the final protocol.
4 weeks after randomization
Usability of Digital Education Resource
Time Frame: 4 weeks after randomization

System Usability Scale (SUS) completed in the app and AI chatbot arms only; report standard 0-100 SUS score (higher indicates greater perceived usability).
4 weeks after randomization
Engagement With Assigned Educational Resource
Time Frame: During the first 4 weeks after randomization

For app: sessions, modules completed and time on task; for chatbot: sessions and messages; for print: self-reported reading frequency and time. Modality-specific metrics are not directly equivalent and may require separate outcome records.
During the first 4 weeks after randomization
Correct Emergency Response to Tooth Avulsion
Time Frame: 4 and 12 weeks after randomization

Prespecified avulsion-vignette subscore from decision-making scenario test, assessing appropriate immediate management. The scoring range must be specified. Distinguish primary-tooth versus permanent-tooth avulsion in the final wording.
4 and 12 weeks after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Anxiety About Managing Dental Emergencies
Time Frame: Baseline and 4 weeks after randomization

Single-item 0-10 numeric rating scale for anxiety, with higher values indicating greater anxiety; clarify exact question text in protocol.
Baseline and 4 weeks after randomization
Knowledge Score at Week 12
Time Frame: 12 weeks after randomization

PDTKQ total score 0-100, higher scores indicate better knowledge.
12 weeks after randomization
Emergency Decision-Making Accuracy at Week 12
Time Frame: 12 weeks after randomization

Scenario test score 0-100, higher scores indicate better emergency decisions.
12 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lincoln University College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bikash Chaurasia, MDS, Lincoln University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUC/SOD/2026/18222/CT4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant-level data for primary and secondary outcomes, with selected demographic and baseline variables, may be shared after publication subject to review of a scientifically sound proposal and an executed data-use/confidentiality agreement.

IPD Sharing Time Frame

From 12 months through 5 years after publication of the main trial results. No sharing before publication.

IPD Sharing Access Criteria

Qualified researchers may submit a methodologically sound proposal to the principal investigator. Requests will be reviewed by the principal investigator and primary sponsor and require approval and a signed data-access/confidentiality agreement. Contact: drbikashaiims@gmail.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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