Comparative Study to Evaluate the Anesthetic Efficacy and Pain Perception of Buffered 4 percent Articaine Versus Non-buffered 4 percent Articaine with Local Anesthesia in Children : A Randomised Split-Mouth Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain perception using VAS and FLACC scale
研究概览
简要总结
Effective pain management is a crucial aspect of pediatric dentistry, as it directly affects a child’s comfort, cooperation, and overall experience during dental procedures. Ensuring adequate anesthesia is essential to minimizing discomfort and anxiety, which can influence a child’s willingness to undergo treatment. Local anesthetics serve as the primary method for pain control in dentistry, with lidocaine being the most commonly used due to its well-documented safety and reliability. However, articaine has gained popularity in recent years due to its superior ability to diffuse through tissues, making it particularly beneficial in regions with dense bone structures.
One common challenge with local anesthesia is the discomfort associated with injections, as well as variability in the time it takes for the anesthetic to take effect and how long it lasts. To improve the efficiency and comfort of anesthesia, buffered anesthetic solutions have been introduced. These formulations work by adjusting the pH of the anesthetic to be closer to the body’s natural levels, which can help reduce pain during injection, speed up the onset of anesthesia, and improve its overall effectiveness.
The purpose of this study is to evaluate the clinical performance of buffered 4% articaine compared to non-buffered 4% Articaine in pediatric dental procedures using a randomized crossover split-mouth design. The study will focus on key factors such as the time it takes for the anesthetic to take effect, the level of pain experienced during injection, and the duration of numbness achieved. By analyzing these aspects, the research aims to determine whether buffered articaine offers significant advantages over conventional non-buffered articaine in managing pain for pediatric dental patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children who are between 6 to 12 years old 2.Healthy children (ASA I) 3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention 4.Willingness to participate in two sessions 5.No history of adverse reaction to anesthetic.
- •6.Children with no Physical or Cognitive disablities 7.Patient reporting to the dental operatory for the first time to minimize behavioural bias 8.Children requiring pulp therapy procedures.
排除标准
- •1.Allergy to articaine anesthetic drugs 2.Local anesthetic drug administered within the week before the session in which they participated 3.Highly symptomatic teeth 4.Localised Lesion at the site of infection 5.Children with prior dental experience 6.Patients with developmental or linguistic disorders who cannot communicate properly 7.Children with medications which affect behaviour 8.Medically and systematically compromised patients 9.Patients with cognitive impairments or special needs.
结局指标
主要结局
Pain perception using VAS and FLACC scale
时间窗: At baseline
次要结局
- The start of the action, duration of postoperative analgesia, & occurrence of any problems. The duration of(anesthesia was assessed by the feeling of numbness & the first sign of pain.)