Pain perception during local anestheisa administration using computer controlled local anesthesia delivery system Star Pen and Buzzy system in pediatric dental procedures a- Randomised Clinical Trial.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- To compare and evaluate pain perception during local anaesthesia administration using a computer controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures
研究概览
简要总结
Pain is a complex, multidimensional concept that can vary in quality, intensity, duration, location, and unpleasantness. Moreover, the ideas of pain pertinent to children differ from those applicable to adults, possibly due to different cognitive development levels. In dentistry, the most common way to relieve this pain is through local anaesthesia (LA). In particular, needle-related procedures are significant sources of fear and anxiety in children. Extreme pain could result in short or long-term physiological, psychological, and emotional outcomes, especially after a needle experience during the first dental visit, which will adversely impact the child’s overall oral health and well-being.
Various techniques have been attempted to effectively control the pain during injection, such as buffering, warming, and adjusting the rate of local anaesthetic infiltration; application of topical anaesthetic vibration using modern devices like Dental Vibe and VibraJect and use of a computer-controlled anaesthetic delivery system.
However, these advanced techniques involve a high cost. Despite dental advancements, pain and anxiety continue to be problems with injections. However, no standard injection method has been established.
Hence, the present study was planned to compare and evaluate pain perception during local anaesthesia administration using a computer-controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures.
Aim To compare and evaluate pain perception during local anaesthesia administration using a computer-controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures
Objectives1. To compare the pain experience in children undergoing local anaesthetic administration in the Buzzy and Star pen groups.
2.To determine and compare the dental anxiety in children undergoing local anaesthetic administration in the Buzzy and Star pen groups.
The randomised clinical trial will be done with 118 children in the Department of Paediatric and Preventive Dentistry at Narayana Dental College and Hospital in Nellore.
Informed consent will be obtained from the parents of the children who are willing to participate in the study.
Children between the ages of 4 and 9 who require pulpectomy and extraction and need local infiltration will be randomly split into two groups.
Group 1 Buzzy device, and Group 2 Star Pen with 59 children in each group. After that, the area to be injected will be anaesthetized by applying 2% lignocaine hydrochloride topical gel for 15 to 20 sec. In Group 1, the children were initially introduced to the device by demonstrating its function in simple words; next, the child will be allowed to play with the Buzzy for familiarisation with the device. Later, the device will be connected to the frozen wing and placed extra orally above the cheek region, where the LA of 1.8 mL of 2% lidocaine with 1:100,000 adrenaline will be administered using manual injection. Whereas, in group 2, after topical application of LA, the infiltration will be given using a computerised controlled local anaesthetic device the star pen, which has an algorithm control with constant pressure feedback technology.
Finally, pain perception in both groups will be recorded using the Memoji Pain Scale immediately after the injection. Anxiety will be recorded using the RMS pictorial scale. Physiological parameters will be recorded using a pulse oximeter before, during, and after LA administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Children in the range of 4-9 years
- •The requirement of local anesthetic administration in the maxilla and mandible for pulp therapies and extraction of primary teeth
- •Children who had no prior experience with local anesthesia administration
- •Children who gave their permission and whose parents provided a written informed consent
- •According to the Frankl behavior rating scale, children who fall under positive and negative categories.
排除标准
- •Children with any systemic diseases and mental illness
- •Children with any previous dental pain or problems entailing emergency dental treatments 3.
结局指标
主要结局
To compare and evaluate pain perception during local anaesthesia administration using a computer controlled local anaesthesia delivery system Star Pen and the Buzzy system in paediatric dental procedures
时间窗: Pain perception in both groups will be recorded using the Memoji Pain Scale immediately after the injection
次要结局
- To determine and compare the dental anxiety in children undergoing local anesthetic administration in the Star pen and the Buzzy system(Anxiety will be recorded using the RMS pictorial scale before, during and after injection)
研究者
D K Lekha
Narayana Dental College and Hospital
