Anesthetic Effectiveness of Mental/incisive Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular I. and II. Premolars with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale
研究概览
简要总结
The goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. This study aims to address gaps in current evidence and clarify whether these anesthesia techniques differ in effectiveness and patient experience during endodontic procedures. The hypotheses include: (i) no difference in pain perception between IANB and MNB, (ii) no difference between first and second premolars with IANB, and (iii) no difference between first and second premolars with MNB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Individuals classified as ASA 1 or ASA
- •Age range of 18 to 65 years.
- •No known allergies to articaine or epinephrine.
- •Absence of facial paresthesia.
- •No use of analgesic medications within 6 hours prior to treatment.
- •No use of medications, such as tricyclic antidepressants or beta blockers, that may interfere with anesthesia.
- •No pathological conditions at the planned injection site.
- •Periodontal pocket depth of 3 mm or less.
- •Mandibular first or second premolars diagnosed with symptomatic irreversible pulpitis.
- •Teeth meeting Glickman's gingival health criteria upon periodontal examination.
- •Radiographically closed root apex with no detectable pathology.
- •Patients must be literate and able to comprehend the use of a pain scale to provide informed consent voluntarily.
排除标准
- •Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
- •Pregnancy.
- •Documented allergy to articaine with 1:100,000 epinephrine.
- •Evidence of periapical pathology or radiolucency observed in radiographs.
- •Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
- •Absence of reported lip numbness 10 minutes following IANB or MINB injection. Presence of a large restoration on the affected tooth.
结局指标
主要结局
Numerical Rating Scale
时间窗: Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.
The patients were asked to rate the pain experienced during endodontic access cavity preparation and pulp extirpation using a Numerical Rating Scale. The Numerical Rating Scale was printed on A4 paper, scaled to fit horizontally, with values from 0 to 10 displayed along a bar. The Numerical Rating Scale uses a 0 to 10 scale, with increments of one unit. Patients were instructed to mark '0' if they experienced no pain, select a value between "1" and "3" for mild pain, a value between "4" and "6" for moderate pain, and a value between "7" and "10" for severe pain.
次要结局
未报告次要终点
研究者
Tolga Sulek
Specialist of Endodontics
Cukurova University