Comparison of the Effects of Submucosal and Intraligamentary Dexamethasone Administration on Anesthetic Success and Pain Control in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Success of Inferior Alveolar Nerve Block Anesthesia
研究概览
简要总结
Symptomatic irreversible pulpitis is associated with a high incidence of inadequate pulpal anesthesia during endodontic treatment, particularly in mandibular molar teeth. Failure to achieve profound anesthesia may result in increased intraoperative pain and patient discomfort. Corticosteroids have been suggested as adjunctive agents to improve pain control and reduce inflammatory responses; however, the influence of different local administration techniques on anesthetic success and postoperative pain remains unclear.
The aim of this randomized controlled clinical trial is to compare the effects of submucosal and intraligamentary dexamethasone administration on anesthetic success and pain control in patients with symptomatic irreversible pulpitis. A total of 84 participants requiring root canal treatment of mandibular first or second molars diagnosed with symptomatic irreversible pulpitis will be randomly allocated to one of three groups: (1) inferior alveolar nerve block (IANB) followed by submucosal saline injection (control group), (2) IANB followed by submucosal dexamethasone injection, and (3) IANB followed by intraligamentary dexamethasone injection.
All participants will receive standardized endodontic treatment under local anesthesia. The primary outcome measure is anesthetic success during access cavity preparation and pulp extirpation. Secondary outcome measures include postoperative pain intensity at 6, 12, 24, 48, and 72 hours, and postoperative analgesic consumption. The results of this study may provide evidence regarding the effectiveness of different local dexamethasone administration techniques and contribute to improved pain management strategies in endodontic practice.
详细描述
Symptomatic irreversible pulpitis is associated with a high incidence of failure of inferior alveolar nerve block anesthesia, particularly in mandibular molars, resulting in pain during endodontic treatment and the frequent need for supplemental anesthesia. Corticosteroids have been investigated as adjunctive agents because of their anti-inflammatory properties and their potential to improve anesthetic success and reduce postoperative pain. However, limited evidence is available regarding the influence of different local administration techniques on these outcomes.
This prospective, randomized, controlled, single-blind clinical trial aims to compare the effects of submucosal and intraligamentary administration of dexamethasone on anesthetic success and postoperative pain following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis of mandibular first or second molars.
Eighty-four participants will be randomly allocated into three parallel groups (28 participants per group):
Group 1 (Control): Inferior alveolar nerve block followed by submucosal injection of normal saline (placebo).
Group 2: Inferior alveolar nerve block followed by submucosal injection of dexamethasone.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 65 years.
- •ASA I or ASA II systemic health status.
- •Symptomatic irreversible pulpitis in a mandibular molar tooth.
- •Positive response to pulp sensibility tests.
- •Preoperative pain score greater than 54 mm on the Heft-Parker Visual Analog Scale (HP-VAS).
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Pregnancy or lactation.
- •Allergy or contraindication to articaine, dexamethasone, or study-related medications.
- •Use of analgesics, anti-inflammatory drugs, or antibiotics within the previous 12 hours.
- •Presence of periapical radiolucency or diagnosis of pulpal necrosis.
- •Significant systemic disease (ASA III or higher).
- •Inability to complete pain assessment forms or follow study procedures.
研究组 & 干预措施
Control Group
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
干预措施: Saline (0.9%, sterile, for infusion) (Drug)
Intraligamentary Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
干预措施: Dexamethasone (Drug)
Submucosal Dexamethasone
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Success of Inferior Alveolar Nerve Block Anesthesia
时间窗: Periprocedural (during access cavity preparation and pulp extirpation)
Anesthetic success will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation. Successful anesthesia is defined as no pain or mild pain (HP-VAS \<54 mm) without the need for supplemental anesthesia. Moderate or severe pain (HP-VAS ≥54 mm) or the need for supplemental anesthesia will be considered anesthetic failure.
次要结局
- Postoperative Pain Intensity(6, 12, 24, 48, and 72 hours after treatment)
- Need for Postoperative Analgesic Medication(Up to 72 hours after treatment)