AI-supported child-friendly communication to reduce dental anxiety during local anesthesia in children
Evaluation of the Effect of Traditional Behavior Management Techniques and AI-Assisted Child-Friendly Communication on Dental Anxiety in Pediatric Dental Anesthesia Applications
This compares AI-assisted child-friendly communication with traditional behavior techniques to see if it reduces anxiety, stress, and pain during local anesthesia in children aged 6–12.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Çanakkale Onsekiz Mart University Academic / other |
| Locations | 1 site (Çanakkale, Kepez) |
| Trial ID | NCT07133919 on ClinicalTrials.gov |
What this trial studies
Healthy children aged 6–12 who need an inferior alveolar nerve block for restorative mandibular treatment and are on their first dental visit will be enrolled and randomized to either traditional behavior management or an AI-assisted child-friendly communication intervention. Baseline demographic and dental data plus Frankl behavior scores will be recorded, and physiological stress, self-reported pain, and observable anxiety markers will be measured around the anesthesia procedure. The AI arm uses conversational/distractive AI tools and possibly audiovisual aids to tailor communication to the child's developmental level, while the control arm receives standard Tell-Show-Do and positive reinforcement techniques. Outcomes will compare anxiety, physiological stress responses, and pain perception between groups.
Who should consider this trial
Good fit: Systemically healthy children aged 6–12 in mixed dentition on their first dental visit who require inferior alveolar nerve block for mandibular restorative procedures and have Frankl behavior scores of 2 or 3 are ideal candidates.
Not a fit: Children outside the 6–12 age range, those with prior local anesthesia experience, severe behavior problems (Frankl score 1) or extreme uncooperativeness, systemic health issues, or who do not require an IANB are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower anxiety and pain during injections and make dental visits more comfortable and cooperative for children.
How similar studies have performed: Previous work using AI-enhanced audiovisual tools like virtual reality has reduced pediatric dental anxiety and pain, but application of conversational AI tools such as ChatGPT in this context is relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children volunteers and their parents/legal guardians who have read and signed the informed consent form and agreed to participate in the study * Systemically healthy children aged 6-12 years in the mixed dentition period * Children requiring restorative dental procedures (including pulpotomy, pulp capping, or composite restorations) on mandibular teeth under inferior alveolar nerve block local anesthesia * Children who are attending their first dental visit and demonstrate behavior rated as 2 (negative) or 3 (positive) according to the Frankl Behavior Rating Scale (Categories: 1 - definitely negative; 2 - negative; 3 - positive; 4 - definitely positive) Behaviors will be categorized as positive (+) or negative (-) based on the Frankl Behavior Rating Scale (Wright's modification) * Children receiving local anesthesia for the first time Exclusion Criteria: * Children volunteers and their parents/legal guardians who read the informed consent form but declined to participate in the study * Children with systemic diseases requiring continuous medication * Children with mental or cognitive impairments, as well as those with visual or hearing disabilities * Children who, after oral prophylaxis at the first visit, exhibit "definitely negative" (Frankl 1) or "definitely positive" (Frankl 4) behavior according to the Frankl Behavior Rating Scale * Children with previous experience of local anesthesia
Where this trial is running
Çanakkale, Kepez
- Canakkale Onsekiz Mart University — Çanakkale, Kepez, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Burak Çarıkçıoğlu, Associate Professor
- Email: carikcioglub@gmail.com
- Phone: 00905054956091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.