Efficacy of Lidocaine Hydrogel with Eugenol as a Topical Anesthetic for Pain Management During Crown Preparation in Pediatric Teeth Without Pulp Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain perception using VAS and Wong Baker scale
研究概览
简要总结
This randomized controlled trial assessed the efficacy of Lidocaine Hydrogel with Eugenol as a topical anesthetic for pain control during crown preparations in children (aged 5–10 years) without the need for pulpectomy or pulp therapy. The study compared two groups—one receiving the Lidocaine-Eugenol hydrogel and the other a control (standard care or placebo)—and evaluated pain response using validated scales (e.g., FLACC, Wong-Baker FACES, or physiological measures). The sample size was calculated to detect clinically meaningful differences in pain reduction while accounting for potential attrition. Results determined whether this combination provided faster, longer-lasting, or better-tolerated anesthesia compared to conventional methods, offering a potential minimally invasive alternative for managing discomfort during pediatric restorative procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient reporting to the dental operatory for the first time to minimize behavioural bias 2.Patients from the age group 5 to 10 3.Children not requiring pulp therapy procedures 4.Individuals without any cognitive or systemic disabilities.
排除标准
- •1.Children with prior dental experience 2.Patients with developmental or linguistic disorders who cannot communicate properly 3.Children with medications which affect behaviour 4.Medically and systematically compromised patients 5.Patients with cognitive impairments or special needs.
结局指标
主要结局
Pain perception using VAS and Wong Baker scale
时间窗: at baseline
次要结局
- at 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.)
研究者
Ashish Suresh
Saveetha Dental College and Hospitals