An interventional study of Printed Dental Trauma First-Aid Booklet in Dental Trauma; Traumatic Dental Injury; Parent Education / Emergency Decision-Making, sponsored by Lincoln University College. Not yet recruiting. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Lincoln University College · Not applicable, Interventional, and Other
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.
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.
Lincoln University College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Parental Knowledge of Dental Trauma Emergency Management 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.
Time frame: Baseline and 4 weeks after randomization (primary comparison at week 4)
Dental Trauma Emergency Decision-Making Accuracy at Week 4
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.
Time frame: 4 weeks after randomization (primary comparison); 12-week results recorded separately as follow-up
Knowledge Retention at Week 12
Change in PDTKQ score from week 4 to week 12 (0-100 scale; positive values indicate increased knowledge).
Time frame: 4 and 12 weeks after randomization
Parent Confidence in Dental Emergency Management
Study-specific 10-item confidence scale with responses scored 0-10 per item. Specify sum/mean and exact final range before submission.
Time frame: Baseline, 4 and 12 weeks after randomization
Satisfaction With Assigned Education Resource
Study-specific 12-item satisfaction survey administered in all three groups; define scoring and interpretation in the final protocol.
Time frame: 4 weeks after randomization
Usability of Digital Education Resource
System Usability Scale (SUS) completed in the app and AI chatbot arms only; report standard 0-100 SUS score (higher indicates greater perceived usability).
Time frame: 4 weeks after randomization
Engagement With Assigned Educational Resource
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.
Time frame: During the first 4 weeks after randomization
Correct Emergency Response to Tooth Avulsion
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.
Time frame: 4 and 12 weeks after randomization
Parent Anxiety About Managing Dental Emergencies
Single-item 0-10 numeric rating scale for anxiety, with higher values indicating greater anxiety; clarify exact question text in protocol.
Time frame: Baseline and 4 weeks after randomization
Knowledge Score at Week 12
PDTKQ total score 0-100, higher scores indicate better knowledge.
Time frame: 12 weeks after randomization
Emergency Decision-Making Accuracy at Week 12
Scenario test score 0-100, higher scores indicate better emergency decisions.
Time frame: 12 weeks after randomization
No study locations are listed for this record.
Plan to share: Yes — 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.
Time frame: From 12 months through 5 years after publication of the main trial results. No sharing before publication.
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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