Determination of the Effect of Two Different Methods of Dental Anaesthesia on Pain Level in Paediatric Patients: A Cross-over, Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- level of opiorphin (from saliva samples)
研究概览
简要总结
Background: Needles are the most feared tools, making anaesthetic injection a worrying practice.
Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that painless anaesthesia.
Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine the anxiety levels and pain experienced by the patients, visual and behavior scales were used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon signed-rank tests were used. p<0.05 was considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 8-10 years,
- •systemically healthy,
- •had undergone dental treatment (except for extraction) previously but with at least 1 week passed since then
- •were compatible enough to undergo therapy in the clinic in a sitting position,
- •had infection between the roots with a rate over 1/3, had 2/3 root formation,
- •had been indicated for extraction of the maxillary primary molar teeth (55/65 No. teeth),
- •did not have acute and/or subacute infection of the related or other teeth or mouth and surrounding tissues
排除标准
- •who scored above 41 in the state anxiety subscale and above 44 in the trait anxiety subscale of the Spielberger State-Trait Anxiety Scale (SSAS-SAAS)
- •not meeting the inclusion criteria
结局指标
主要结局
level of opiorphin (from saliva samples)
时间窗: one year
Score of scales (face, legs, activity, cry, consolability)
时间窗: one year
(0-10) (0= relaxed, 10=severe discomfort)
Score of scales (frankl behavior rating scale)
时间窗: one year
(1-4) (1= definitely negative, 4=definitely positive)
heart rate (pulse oximeter)
时间窗: one year
Score of scales (wong baker faces pain rating scale)
时间窗: one year
(0-10) (0= no hurt, 10= hurts worst)
次要结局
未报告次要终点
研究者
Nagehan Yilmaz
Assistant Prof
Karadeniz Technical University