Comparative evaluation of the effect of Hydroxyethylidene bisphosphonate (HEBP)-Sodium hypochlorite and neem leaf extract as root canal irrigants on post operative pain in symptomatic irreversible pulpitis: A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
研究概览
简要总结
Post-endodontic pain is a significant factor influencing the overall success of root canal therapy. It may result from microbial, mechanical, or chemical factors, including apical extrusion of debris, irrigants, or medicaments during instrumentation. Effective root canal treatment requires thorough debridement, smear layer removal, and three-dimensional obturation while ensuring minimal postoperative discomfortSodium hypochlorite (NaOCl) is widely used for its antimicrobial and tissue-dissolving properties but does not remove the smear layer; therefore, chelating agents such as EDTA are commonly used as adjuncts. However, conventional NaOCl–EDTA protocols may contribute to dentin erosion and postoperative pain. Etidronic acid (HEBP), a soft chelating agent, can be used in combination with NaOCl as a continuous chelator and may offer improved biocompatibility with reduced dentin erosion. Herbal alternatives such as Neem (Azadirachta indica) leaf extract possess antimicrobial and anti-inflammatory properties and may potentially reduce postoperative discomfort, though clinical evidence remains limited.This study is designed to evaluate and compare the effect of three final irrigating regimens—NaOCl with EDTA, NaOCl with HEBP, and Neem leaf extract—on postoperative pain in patients diagnosed with symptomatic irreversible pulpitis. The objective is to identify an irrigating protocol that ensures effective disinfection while minimizing postoperative pain and improving patient comfort.
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
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients requiring endodontic therapy of mandibular molars teeth diagnosed with symptomatic irreversible pulpitis with or without associated apical periodontitis 2.Systemically healthy patients presenting with moderate to severe pain, with a Visual Analog Scale (VAS) score ranging from 3 to 10 (on a 0–10 scale) 3.Systemicallly healthy patients aged between 18 and 55 years who provided written informed consent.
- •4.Teeth exhibiting tenderness on percussion but without well-defined periapical radiographic changes.
排除标准
- •1.Medically compromised patients.
- •2.Teeth exhibiting clearly defined periapical radiolucency, calcified root canals, associated with a sinus tract and periapical abscess.
- •3.Teeth with incomplete apex formation 4.Patients under analgesic medication at the time of assessment.
- •5.Patient on antibiotic therapy.
- •7.Patients failure to report for follow-up visits.
- •8.Patients unable to comply with post-operative pain assessment protocols (e.g., incomplete VAS records).
研究者
Avishkar Dhanraj Patil
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Hingna Nagpur Maharashtra