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临床试验/NCT07133919
NCT07133919招募中不适用

Evaluation of the Effect of Traditional Behavior Management Techniques and AI-Assisted Child-Friendly Communication on Dental Anxiety in Pediatric Dental Anesthesia Applications

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Pulse

研究概览

简要总结

This study compares the effects of traditional behavior management techniques and AI-assisted child-friendly communication on dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 6-12. The aim is to evaluate the effectiveness of AI-supported communication tools in reducing anxiety and improving comfort in pediatric dental treatments, potentially enhancing clinical outcomes and advancing technology use in pediatric dentistry.

详细描述

Successful pediatric dental treatment depends on effective therapeutic communication and tailored behavior management strategies based on the child's needs and the clinician's experience. Local anesthesia often induces dental anxiety, elevated physiological stress, and increased pain perception, which can impair treatment outcomes and contribute to dental phobia. Although traditional techniques like Tell-Show-Do and positive reinforcement are commonly used, their effectiveness may be limited in some children.

The integration of artificial intelligence (AI) and digital technologies has enabled personalized communication strategies adapted to children's cognitive and psychosocial development. AI tools such as ChatGPT act as distraction methods to reduce anxiety and stress during dental procedures. Furthermore, AI-enhanced audiovisual devices like virtual reality (VR) headsets have been shown to decrease dental anxiety, physiological stress responses, and pain perception in pediatric patients.

This study will be conducted with healthy children aged 7 to 12 who require inferior alveolar nerve block (IANB) anesthesia and have Frankl Behavior Rating Scale scores of 2 (negative) or 3 (positive). Demographic and dental data such as age, gender, and treated tooth numbers will be recorded prior to the procedure.

Participants will be randomly assigned into two groups: Group 1 (Control) and Group 2 (ChatGPT).

Control Group (Group 1):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Arm 1: Traditional Behavior Management (Control Group)

Other

干预措施: Traditional Behavior Management Techniques (Behavioral)

Arm 2: AI-Assisted Child-Friendly Communication

Experimental

干预措施: AI-Assisted Child-Friendly Communication (Behavioral)

结局指标

主要结局

Pulse

时间窗: 5 minutes

Throughout the session, pulse levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.

Oxygen Saturation

时间窗: 5 minutes

Throughout the session, saturation levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.

次要结局

  • Change in Facial Image Scale (FIS)" score(Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.)
  • Wong-Baker Faces Pain Rating Scale(within 5 minutes after completion of local anesthesia procedure.)
  • Modified Houpt Behavior Rating Scale score(During treatment)
  • Frankl Behavior Rating Scale(During treatment)
  • Change in "Venham Picture Test (VPT)" score(Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.)
  • Change in "Modified Child Dental Anxiety Scale - faces version (MCDAS-f)"(Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.)

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Carıkcıoglu

Associate Professor

Çanakkale Onsekiz Mart University

研究点 (1)

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