Comparative evaluation of efficacy, hemodynamic changes, and postoperative complications of 2 percent lidocaine using inferior alveolar nerve block and 4 percent articaine using intraosseous anaesthesia in mandibular primary molars of children aged 6 to 8 years: An in vivo, randomized, controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraosseous Anaesthesia using 4% articaine with needle guide system shows:
研究概览
简要总结
Effective pain management is crucial in pediatric dentistry to ensure a positive experience for young patients. The inferior alveolar nerve block (IANB) is commonly used to anesthetize mandibular teeth but has a notable failure rate, especially in children, due to anatomical variations and technical challenges. Studies indicate that IANB can fail in approximately 30% to 45% of cases, even when proper techniques are employed.
Intraosseous anesthesia (IOA) presents an alternative, involving the direct injection of anesthetic into the cancellous bone, potentially offering more reliable anesthesia for mandibular procedures. Recent advancements, such as the TuttleNumbNow (TNN) system, utilize specialized needles to facilitate this technique. Comparative studies have explored the efficacy of 4% articaine versus 2% lidocaine in pediatric patients. Some findings suggest that articaine may provide superior anesthetic success rates and faster onset compared to lidocaine.
However, very few studies have found no significant difference in efficacy between the two anesthetics when used for primary molar extractions in children. The proposed research aims to further evaluate these findings by comparing the efficacy, hemodynamic responses, and postoperative complications of 2% lidocaine via IANB and 4% articaine via IOA in children aged 6–8 undergoing mandibular primary molar procedures. The outcomes could inform best practices in pediatric dental anesthesia, potentially leading to improved patient comfort and treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 6-8 years Medically fit children Mentally capable of communication Having mandibular primary molar tooth that require pulp therapy Tooth without having any kind of history of infection (abscess) or swelling and no evidence of periapical pathosis or soft tissue infection/inflammation near the site of injection.
- •Children, who are cooperative enough to undergo dental procedures and parental informed written consent provided.
- •Tooth, which will give a baseline reading on pulp tester before administration of local anaesthetics.
排除标准
- •Medically and mentally compromised children.
- •History of significant behaviour management problems.
- •Evidence of infection near the proposed injection site as this might affect the efficacy of local anaesthesia like periodontal (periodontal pockets or tooth mobility), radiological alterations (bone loss or periapical radio transparencies).
- •Children who did not speak or understand local language.
- •Children who are allergic to 4% articaine.
结局指标
主要结局
Intraosseous Anaesthesia using 4% articaine with needle guide system shows:
时间窗: Evaluation will be done at the baseline and one week
Faster onset of action in mins
时间窗: Evaluation will be done at the baseline and one week
Better pain control during procedures using WBFS, VAS and SEM scale
时间窗: Evaluation will be done at the baseline and one week
次要结局
- Intraosseous Anaesthesia using 4% articaine with needle guide system showed:(Minimal hemodynamic changes like increase in heart rate)
研究者
Hinal Kanabar
Pacific Dental College And Hospital