Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pain during endodontic access
研究概览
简要总结
This multicenter randomized trial compares the clinical effectiveness of intraligamentary injection versus inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. The goal is to determine which technique provides better pain control during endodontic treatment.
详细描述
Symptomatic irreversible pulpitis in mandibular molars presents a clinical challenge due to the difficulty in achieving profound anesthesia. This prospective, randomized, controlled clinical trial evaluates two anesthetic techniques-intraligamentary injection (ILA) versus inferior alveolar nerve block (IANB)-to compare their efficacy in eliminating pain during endodontic access. Patients will be enrolled from multiple dental centers following standardized inclusion and exclusion criteria. Pain will be assessed using validated scales. Statistical analysis will be conducted to determine significant differences in anesthetic success between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Presenting with symptomatic irreversible pulpitis in a mandibular molar
- •Vital response to cold testing
- •Ability to understand and provide informed consent
- •Available for follow-up and data collection
排除标准
- •Known allergy to lidocaine or epinephrine
- •Pregnancy or breastfeeding
- •Use of analgesics or anti-inflammatory drugs in the previous 6 hours
- •Non-vital or previously treated teeth
- •Significant systemic disease (ASA III or above)
- •History of psychiatric or neurological disorders affecting pain perception
研究组 & 干预措施
Intraligamentary Injection Group
Patients in this arm will receive intraligamentary anesthesia prior to endodontic access.
干预措施: Intraligamentary Injection (Procedure)
Inferior Alveolar Nerve Block Group
Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access.
干预措施: Inferior Alveolar Nerve Block (Procedure)
结局指标
主要结局
Pain during endodontic access
时间窗: Immediately after access cavity preparation (within 30 minutes of anesthesia)
Pain intensity experienced by the patient during endodontic access after the assigned anesthetic technique.
次要结局
- Need for supplementary anesthesia(During access or initial root canal instrumentation (within first 45 minutes))
- Patient satisfaction immediately after treatment(End of visit (within 1 hour))
- Postoperative pain at 7 days(Day 7 post-treatment)
- Patient satisfaction at 7 days(Day 7 post-treatment)
研究者
Guillem Esteve-Pardo
Principal Investigator - DDS, PhD (Bioengineering)
Aula Dental Avanzada