AI-supported child-friendly communication to reduce dental anxiety during local anesthesia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Canakkale Onsekiz Mart University
  Çanakkale, Kepez, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Burak Çarıkçıoğlu, Associate Professor
• Email: carikcioglub@gmail.com
• Phone: 00905054956091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.