Kapov Grace, Linton Kasey, Gatewood Christopher, Liu Chuwen, Strauman Timothy, Hodges Eric, Graves Christina, Sawicki Caroline, Wu Di, Divaris Kimon, Jacox Laura Anne
Department of Orthodontics, Adams School of Dentistry, University of North Carolina, 270 Brauer Hall, CB #270, Chapel Hill, NC, 25799, USA.
Department of Biomedical Sciences, Adams School of Dentistry, University of North Carolina, CB #7455, Chapel Hill, NC, 27599, USA.
Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.
Between 6 and 22% of children are affected by dental anxiety. Dental anxiety is a significant barrier to dental care and is associated with dental avoidance and negative oral health outcomes. Pharmacological methods of anxiety management are costly, carry risks of adverse outcomes, and may not be acceptable to some families. Alternative non-pharmacological methods are needed for the safe and effective delivery of dental care. Although there is an abundance of literature regarding animal-assisted therapy (AAT) in medicine, only preliminary studies on AAT exist in dentistry. To identify optimal outcome measures for evaluating AAT in pediatric dental contexts, a randomized controlled trial protocol was developed.
A prospective randomized controlled trial protocol was developed to examine the impact of AAT on objective (heart rate, salivary stress and pain markers, and observational coding) and subjective self-reported measures of anxiety, pain, and dental expectations in pediatric patients. The study is designed to enroll 180 pediatric patients (4-8 years old), randomized into three arms (n = 60 per arm) with stratification by age (< 6.5 vs ≥ 6.5) and gender (block size = 4). Two therapy protocols (+ Short AAT and + Long AAT exposures) will be compared relative to an active control (coloring a dog picture) during a diagnostic dental visit consisting of an oral exam, dental cleaning, and simulated bitewing intraoral radiographs.
This study will provide information on optimal outcome measures to evaluate the impact of AAT on dental anxiety and behavior in pediatric dental patients. Determining the effects of AAT in pediatric dental care may provide a safe, non-pharmacological method of anxiety and behavior management, with broad translational impact.
This trial was registered on ClinicalTrials.gov with number NCT05464888, on 15 July 2022 (first submitted to ClinicalTrials.gov) and 19 July 2022 (first posted to ClinicalTrials.gov).
6%至22%的儿童受到牙科焦虑的影响。牙科焦虑是获得牙科护理的重大障碍,与回避牙科治疗及负面的口腔健康结果相关。管理焦虑的药物方法成本高昂,存在不良后果风险,且可能不为一些家庭所接受。需要替代性的非药物方法来安全有效地提供牙科护理。尽管有大量关于医学中动物辅助疗法(AAT)的文献,但牙科领域仅有关于AAT的初步研究。为确定评估儿科牙科环境中AAT的最佳结果指标,制定了一项随机对照试验方案。
制定了一项前瞻性随机对照试验方案,以研究AAT对儿科患者焦虑、疼痛和牙科期望的客观指标(心率、唾液应激和疼痛标志物以及观察编码)和主观自我报告指标的影响。该研究计划招募180名儿科患者(4至8岁),随机分为三组(每组n = 60),按年龄(<6.5岁与≥6.5岁)和性别分层(区组大小 = 4)。在一次包括口腔检查、牙齿清洁和模拟咬翼片口腔X光片的诊断性牙科就诊期间,将两种治疗方案(+短时间AAT暴露和+长时间AAT暴露)与积极对照(给狗的图片上色)进行比较。
本研究将提供有关评估AAT对儿科牙科患者牙科焦虑和行为影响的最佳结果指标的信息。确定AAT在儿科牙科护理中的效果可能提供一种安全的、非药物的焦虑和行为管理方法,具有广泛的转化影响。
本试验于2022年7月15日(首次提交至ClinicalTrials.gov)和2022年7月19日(首次发布至ClinicalTrials.gov)在ClinicalTrials.gov上注册,注册号为NCT05464888。