Halabi Manal Al, Hussein Iyad, Salami Anas, Awad Rawan, Alderei Najla, Wahab Ahtiq, Kowash Mawlood
Hamdan Bin Mohammed College of Dental Medicine.
College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.
Medicine (Baltimore). 2019 Aug;98(35):e16978. doi: 10.1097/MD.0000000000016978.
Inhalation sedation is a proven safe method for reducing children's dental anxiety and has been used worldwide for decades. There is controversy regarding the use of acclimatization or familiarization visits for dental sedation treatment pathways for children. This may increase acceptance to the treatment based on desensitization and acclimatization principles underpinning many behavior management techniques. This study aims to identify whether, an inhalation sedation acclimatization visit is effective in reducing the stress level in anxious children as measured by salivary Alpha Amylase and Cortisol levels.
The study is a single-center, single blinded, parallel group 2 arm clinical trial. Children in need of inhalation sedation aged 5 to 15 years from September 2019 through March 2020 attending the Postgraduate Pediatric Clinic at the Hamdan Bin Mohammed College of Dental Medicine, in Dubai, will be allocated randomly and equally to either:At the initial visit a salivary sample will be collected at the beginning of the visit and the sedation need score will be recorded using the pediatric indicator of sedation need. Treatment for both groups will commence at the second visit. Salivary samples will be collected 15 minutes before the start of the treatment and 15 minutes after the conclusion of the treatment. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment using Frankl rating behavior scale and physiological anxiety related changes will be recorded using salivary Alpha Amylase and Cortisol levels. Mean changes of physiologic anxiety levels and corresponding 95% confidence intervals will be determined to compare the 2 treatments (sedation with familiarization and sedation without familiarization).
This is will be the first study to measure the effect of the acclimatization visit of nitrous oxide inhalation sedation on the level of physiological anxiety and the behavior of the pediatric patients during treatment.
吸入镇静是一种经证实的减轻儿童牙科焦虑的安全方法，已在全球使用数十年。对于儿童牙科镇静治疗途径中使用适应或熟悉就诊环节存在争议。基于许多行为管理技术所依据的脱敏和适应原则，这可能会提高对治疗的接受度。本研究旨在确定吸入镇静适应就诊是否能有效降低焦虑儿童的应激水平，这通过唾液α淀粉酶和皮质醇水平来衡量。
该研究是一项单中心、单盲、平行组双臂临床试验。2019年9月至2020年3月期间，在迪拜哈姆丹·本·穆罕默德牙科学院研究生儿科诊所需要吸入镇静的5至15岁儿童将被随机且平均分配到以下两组：在初次就诊时，将在就诊开始时采集唾液样本，并使用儿科镇静需求指标记录镇静需求评分。两组的治疗均在第二次就诊时开始。将在治疗开始前15分钟和治疗结束后15分钟采集唾液样本。将记录以下结果：牙科治疗的完成情况、使用弗兰克行为评级量表在基线和治疗后的焦虑评分，以及使用唾液α淀粉酶和皮质醇水平记录与生理焦虑相关的变化。将确定生理焦虑水平的平均变化及相应的95%置信区间，以比较两种治疗方法（有熟悉就诊环节的镇静和无熟悉就诊环节的镇静）。
这将是第一项测量一氧化二氮吸入镇静适应就诊对儿科患者治疗期间生理焦虑水平和行为影响的研究。
