Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Anesthetic efficacy
研究概览
简要总结
This randomized controlled trial aims to compare the anesthetic efficacy of 2% lignocaine administered through an inferior alveolar nerve block (IANB) in one group of participants with 4% articaine delivered via primary buccal infiltration in other group in patients with symptomatic irreversible pulpitis in mandibular first molars.
详细描述
This single-blinded randomized controlled trial evaluates the comparative anesthetic efficacy of two routinely used local anesthetic techniques for mandibular first molars diagnosed with symptomatic irreversible pulpitis. Inferior alveolar nerve block (IANB) using 2% lidocaine is a standard but technique-sensitive approach with reported failure rates of 20-25%, often influenced by anatomical variations and pulpal inflammation. Primary buccal infiltration with 4% articaine has emerged as a promising alternative due to superior bone penetration and favorable clinical outcomes in several studies, though evidence in adult South Asian populations remains limited.
A total of 330 systemically healthy adults (ASA I, aged 18-55 years) meeting strict diagnostic criteria for symptomatic irreversible pulpitis will be enrolled. Participants will be randomized into two groups:
- Group 1: 2% lidocaine (1:80,000 epinephrine) via IANB
- Group 2: 4% articaine (1:100,000 epinephrine) via primary buccal infiltration
All injections will be standardized to 1.8 mL delivered over 60 seconds using 27-gauge needles by a single experienced clinician. Topical anesthesia with benzocaine 20% will be used prior to injection. Dental anxiety will be screened using Corah's DAS, and patients with high or phobic anxiety scores will be excluded.
Fifteen minutes after administration, soft-tissue anesthesia will be confirmed (lip numbness for IANB and buccal probe response for infiltration). Pulpal anesthesia will be objectively assessed using an electric pulp tester (EPT) and subjectively using the Heft-Parker Visual Analogue Scale (VAS) at multiple treatment stages: baseline, post-injection, access preparation, pulp chamber entry, and root canal instrumentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the type of local anesthetic technique administered. They will not be informed whether they received an IANB with 2% Lignocaine or Buccal Infilteration with 4% Articaine. The operator and investigator can not be blindeddue to the nature of the procedure.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients classified as ASA I, aged 18-55 years.
- •Permanent mandibular first molar tooth requiring endodontic therapy.
- •Diagnosed with symptomatic irreversible pulpitis without swelling or sinus.
- •Normal periapical radiographic appearance (no evidence of periapical pathology).
- •Moderate pain as assessed by the Heft-Parker VAS (>54 mm and <114 mm).
- •Lingering pain or prolonged response to cold testing (lasting more than 10 seconds).
- •Positive response to electric pulp testing.
- •Outcome assessed must be pulpal anesthesia
排除标准
- •• Pregnant or lactating mothers.
- •Teeth with reversible pulpitis, previously treated, or with calcified canals.
- •Teeth with severe periodontal disease or periapical radiolucency.
- •Patients who have taken analgesics or anti-inflammatory drugs within 6 hours before the treatment visit.
- •Patients on medications that could potentially interact with the anesthetic solution (e.g., antihypertensives, anticoagulants).
- •History of allergy to 4% articaine, lidocaine, or epinephrine.
- •Systemic diseases, immunocompromised states, or significant anxiety/mental health disorders.
- •History of vasovagal syncope on local anesthetic administration
研究组 & 干预措施
ARM 2 : 4% Articaine with 1:100,000 epinephrine
Participants in this group will receive 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar.
干预措施: INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine (Other)
ARM 1 : 2%Lignocaine 1:80,000 epinephrine
: 2% Lignocaine Inferior Alveolar Nerve Block (IANB) Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine.
干预措施: INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine (Other)
结局指标
主要结局
Anesthetic efficacy
时间窗: 1 hour after administration of anesthetic agent
Description: Patients will be assigned to one of the two groups . Group 1: 2%Lignocaine 1;80,000 epinephrine 1.8 ml IANB Group 2: 4%Articaine 1:100,000 epinephrine 1.8 ml Primary buccal infilteration Efficacy will be considered if there are 2 consecutive non-responsive readings during 60 mins duration , usually measured on EPT 15 mins after administration of anesthesia . Any pain felt during the procedure will be measured according to Heft-Parker VAS and moderate-severe pain reported (VAS ≥ 55) will be regarded unsuccessful . Time Frame: 1 hour after administration of local anesthetic agent .
次要结局
- Duration of anesthesia(1 hour 30 mins)
研究者
Sadia Shehzadi
Dr. Sadia Shehzadi
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi